Current Openings
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Responsibilities:
- Manage activities of multidisciplinary product development teams to achieve project timelines, from feasibility/proposal stage through clinical development.
- Identify opportunities to improve efficiency, remove barriers and enable the cross-functional team to execute on goals and objectives.
- Generate and manage project timelines.Proactively identify critical path activities and resource requirements to ensure successful delivery of program goals and objectives.
- Identify program timeline, resource, budget, and key technical risks as well as mitigations; communicate risks and mitigations to leadership, and work with team members to implement solutions.
- Facilitate project meetings, keep team members focused on the highest value-driving activities to align on decisions as quickly as feasible
- Track project progress and achievements – present on project status at regular intervals
Requirements:
- Minimum 3-5 years of prior project/program management experience in the Life Sciences (Biotech, Biopharma or Med Device)
- Demonstrated experience managing complex, large-scale development projects with cross-functional teams.
- An innovative mindset to recognize and solve unexpected challenges in a timely manner.
- Demonstrated expertise in delivering value to the organization and benefit to patients.
- Excellent cross-functional expertise, analytical thinking, and agile mindset to manage rapidly changing and competing priorities.
- Experienced in leading projects involving manufacturing scale-up and tech transfer, regulatory submissions, and clinical studies.
- Enthusiastic about cell and gene therapy discovery and development
- Excellent oral & written communication skills
- B.S. required; advanced degree (M.S./Ph.D.) within an engineering or scientific discipline is a plus.
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Sigilon Therapeutics is seeking a Scientist to join the Assays group, which develops and performs biological assays for multiple therapeutic programs across the company.
Responsibilities
- Independently develop and perform standardized protocols for quantifying and assessing the activity of therapeutic proteins, including ELISA / MSD, cell-based assays, and biochemical/enzymatic assays.
- Assess scientific literature in a variety of therapeutic areas to design experiments and develop/optimize assays.
- Analyze, interpret, and present experimental data in multidisciplinary team meetings.
- Write and review SOPs, study reports, posters/publications, and technical sections of regulatory filings.
- Coordinate with molecular / cell biology, engineering, and in vivo team members to ensure timely delivery of assay data.
- Manage projects with external labs and assay transfers.
- Review internally / externally generated analytical data for accuracy.
- Maintain detailed records in electronic lab notebook and sample management system.
- Evaluate and facilitate the adoption of new technology/equipment to expand the capabilities of the Assays group.
Requirements
- Ph.D. in biochemistry, cell biology, molecular biology, or related discipline.
- At least 2 years of experience in the pharmaceutical/biotechnology industry, specifically in developing bioassay protocols.
- Experience with cell and molecular biology techniques, including ELISA / MSD, Western blot, mammalian cell culture, and other gene/protein expression assays.
- Experience with plate-based readers and analysis software, such as SoftMax Pro, BioTek Gen5, GraphPad Prism, and Excel.
- Exceptional attention to detail, particularly as it relates to the accuracy and precision of assays.
- Experience with assay qualification and validation in a GLP environment is a plus.
- Ability to work effectively with minimal supervision after initial training.
- Ability to set priorities and multi-task activities to effectively manage workflows and deliverables.
- Strong team orientation, with excellent written and oral communication skills.
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Sigilon Therapeutics is searching for an energized and highly motivated candidate Assistant/Associate Scientist to be part of a team focused on developing a novel therapeutic product for diabetes utilizing Sigilon’s Afibromer™ technology combined with leading edge pancreatic islet cell technology. The candidate should have experience with cell culture and with cellular and biochemical assays.
Responsibilities
- Establish protocols and SOPs for laboratory procedures and assays
- Perform cell-based and biochemical assays, including cell viability, ELISA, functional assays, immunohistochemistry, and qPCR
- Prepare critical reagents for execution of assays and laboratory activities
- Help maintain laboratory equipment
- Demonstrate understanding and application of relevant scientific literature to the design of experimental protocols
- Make observations, evaluate data, interpret results and document in a well-maintained laboratory notebook
- Present results of experiments and findings in multidisciplinary team meetings
- Coordinate with a collaborative team of scientists to ensure the completion of the team’s research objectives
- Comply with standard laboratory practices and company policies
Requirements
- BS or MS degree with a focus in biology, biochemistry, bioengineering, or related field
- 1+ years laboratory experience in industry or academia
- Experience in cell culture and cell-based and biochemical assays, e.g. ELISA, microscopy, immunohistochemistry, qPCR
- Outstanding interpersonal skills and established collaborative working habits
- High attention to detail and ability to operate independently
- Excellent oral and written communication skills
- Must enjoy coming to work and having fun while creating therapies that improve the lives of patients
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Sigilon Therapeutics is seeking an experienced and energetic individual to lead all aspects of the execution and management of Phase 1-4 clinical trials in rare diseases. The successful candidate must have excellent communication skills and the ability to work independently in a highly interactive and fast-paced environment.
Responsibilities:
- Manage all aspects of CRO/vendor selection, including request for proposal, CRO evaluation and selection
- Manage all aspects of clinical trials from study start-up to close-out while adhering to FDA, EMEA, GCP, and ICH guidelines
- Oversee CRO and vendor activities, including day-to-day management as well as review of metrics/key performance indicators (KPIs)
- Participate in start-up activities to ensure efficient and accurate study timelines and timely site activation
- Serve as a point of escalation for study teams and CROs
- Review and contribute to authorship of clinical study protocols, informed consent forms (ICFs), study manuals, clinical study reports (CSRs) and other clinical documents, as necessary
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationship
- Attend monitoring visits as needed
- Effectively communicate and interact with Key Opinion Leaders
- Collaborate with the cross-functional team at Sigilon to ensure close communication and accurate planning for upcoming and/or ongoing studies
- Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings
- Facilitate risk assessment planning and timely resolution of issues
- Participate in Case Report Form design, user acceptance testing in partnership with the CRO
- Ability to travel (~ 20%) post COVID
Requirement/Qualifications:
- Bachelor’s degree in life sciences or healthcare related field
- At least 5 years clinical research experience in a CRO or pharmaceutical company, with at least 3 years direct experience managing complex, international studies
- Experience in gene and cell therapy product and/or rare disease is desirable
- Proven experience overseeing CROs and managing all operational aspects of clinical studies
- Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close-out procedures
- Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations as required
- Experience working closely with study sites, Key Opinion Leaders (KOLs) and external vendors
- Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
- Proven ability to work independently, take initiative, and effectively handle multiple priorities
- Excellent interpersonal/team skills, strong organizational skills
- Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
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Sigilon Therapeutics is seeking an Assistant/Associate Scientist to join the Bioanalytics group, which develops and performs biological assays for multiple therapeutic programs across the company.
Responsibilities
- Perform standardized protocols for quantifying and assessing the activity of therapeutic proteins, including ELISA/MSD, cell-based assays, and biochemical/enzymatic assays.
- Prepare and manage inventory of critical reagents.
- Assist with assay development and internal/external assay transfers.
- Analyze, interpret, and present experimental data in multidisciplinary team meetings.
- Coordinate with cell biology, engineering, and in vivo team members to manage assay request queue and ensure timely delivery of assay data.
- Maintain detailed records in electronic laboratory notebook and sample management system.
Requirements
- BS/MS in biochemistry, cell biology, molecular biology, or related discipline.
- 0 - 3 years of experience in the pharmaceutical/biotechnology industry, specifically in performing bioanalytical assays.
- Experience with biochemical and cell/molecular biology techniques, including ELISA/MSD, Western blot, mammalian cell culture, and other gene/protein expression assays.
- Experience with plate-based readers and analysis software, such as SoftMax Pro, BioTek Gen5, GraphPad Prism, and Excel.
- Exceptional attention to detail, particularly as it relates to the accuracy and precision of assays.
- Experience with assay qualification/validation or sample analysis in a GLP environment is a plus.
- Ability to work effectively with minimal supervision after initial training.
- Ability to set priorities and multi-task activities to effectively manage workflows and deliverables.
- Strong team orientation, with excellent written and oral communication skills.
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Sigilon Therapeutics is searching for an energized and highly motivated Process Engineer to be part of the CMC team focused onenhancing and evolving the manufacturing process for Sigilon’s encapsulated allogeneic cell therapy platform. Key objectives will be to provide process engineering support across the CMC group in developing robust and scalable cell therapy bioprocesses.
Responsibilities:
- Identify and evaluate appropriate process equipment and design alternatives for scale-up based on “design of manufacturability” principles.
- Provide process engineering support for PD in executing laboratory studies that support the evaluation, development, and implementation of new technologies for cell therapy manufacturing.
- Maintain and set up devices for biopolymer encapsulation systems.
- Conduct experiments in support of developing, evaluating, and characterizing processes. Utilize statistical software in the design and evaluation of data.
- Provide process engineering support for troubleshooting technical issues associated with key process equipment.
- Provide engineering support internally and externally with GMP Manufacturers. Aid in the transfer of process equipment know how to CMOs.
- Assist scale-up activities in collaboration with Process Development teams.
- Establish methods for process trending, statistical models, and best practices for GMP operations.
- Ensure phase-appropriate manufacturing, with an appreciation of late-stage manufacturing including process characterization and process validation activities.
Requirements
- B.Sc./M.Sc. degree with a focus in chemical/process engineering or related discipline.
- Must have 5+ years of industry experience in drug product development and/or manufacturing.
- Experience in biomaterials, tissue engineering or microfluidic systems integration is desirable.
- Hands-on experience with bioreactors is a plus.
- Desired to have experience in cell and gene therapy or biologics.
- Desired to have experience working in a multi-disciplinary CMC team.
- Must have strong attention to detail.
- Excellent oral and written communication skills
- Outstanding interpersonal skills and established collaborative working habits.
- Knowledge of or experience with lean / six sigma practices
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Sigilon Therapeutics is looking for an experienced Process Development scientist/engineer to be part of our CMC technical team. The role reports to the Head of Process Development and is responsible for developing and implementing organizational processes/procedures that enable technical teams to effectively progress programs from preclinical stages through commercialization. In addition, the position requires a hands-on approach in the development and execution of experiments to realize strategic process improvements, optimize outcomes, and define Critical Quality Attributes. The ideal candidate should possess a strong development background and the ability to successfully interface with multidisciplinary teams. Key objectives are to enhance and evolve the manufacturing processes for Sigilon’s encapsulated allogeneic cell therapy platform by providing the team with the necessary technical information, experimental expertise, and procedural tools for success.
KEY RESPONSIBILITIES
- Oversee the development and implementation of technical SOPs and procedures
- Assist Process Development team in implementing Best Practices
- Manage Process Development CAPEX budget
- Conduct experiments to support strategic process optimization
- Hands-on participation in implementing new technologies
- Implement Lean Sigma/Six Sigma practices
- Assist in designing and procuring equipment
- Participate on project teams as needed
- Develop and maintain metrics to track technical progress
- Coach and mentor team members on development practices
- Assist teams with planning, and trouble-shooting
- Review technical documents and provide feedback and guidance to technical teams
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
- PhD in chemistry, biology, engineering, or a related discipline with a minimum of five years of development experience
- Hands-on experience with Lean Sigma or Six Sigma practices
- Experience with creating SOPs and implementing development procedures
- Excellent communications skills
- Strong trouble-shooting skills
- Breadth of knowledge across bioprocessing technologies
- Working knowledge of biologics CMC regulations and cGMP requirements
- Ability to communicate and represent group to a variety of stakeholders
- Ability to work with cross-functional teams
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Sigilon Therapeutics is searching for an energized and motivated part time assistant to be part of a team focused on developing a novel therapeutic product for diabetes utilizing Sigilon’s Afibromer™ technology combined with leading edge pancreatic islet cell technology. The candidate should have excellent attention to detail and organizational skill. 3-4 days a week with mutually agreeable schedule to be determined.
Responsibilities
- Order and organize reagents
- Prepare critical reagents for execution of assays and laboratory activities
- Help maintain laboratory equipment
- Observe and track experimental progress using microscopy, cell counting, and simple molecular biology protocols and keep track of result in an electronic laboratory notebook
- Coordinate with a collaborative team of scientists to ensure the completion of the team’s research objectives
- Comply with standard laboratory practices and company policies
Requirements
- BA, BS or MS degree, focus in biology, biochemistry, bioengineering, or related field a plus but not required
- No laboratory experience needed, we will train
- High attention to detail and ability to operate independently
- Outstanding interpersonal skills and established collaborative working habits
- Excellent oral and written communication skills
- Must enjoy coming to work and having fun while creating therapies that improve the lives of patients
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The position will be responsible for leading our efforts on clonal cell line development and characterization. A successful candidate has experience with single cell cloning and related technologies as well as a deep understanding of transfection and protein expression strategies. Experience with many molecular biology techniques for cell line characterization is a must. This role will require excellent organizational and documentation skills. Presentation of written and oral summaries of progress in team meetings as well as to management is expected. This employee will maintain a safe laboratory environment.
Responsibilities:
- Clonal isolation of cell lines and screening of clones. Use of single cell sorters, FACs, and cell growth imaging instruments.
- Establishing transfection protocols.
- Tissue culture of primary cells and cell lines.
- Participate in the scale-up up of clones.
- Characterization of clones using multiple molecular biology techniques including Western blot, ELISA, activity assays, genomic DNA extraction, ddPCR.
- Exceptional documentation and tracking of cell lines via work instructions while keeping a close working relationship with Quality.
- Demonstrate understanding and application of relevant scientific literature to improve the cloning process.
- Understand biology of a multitude of rare diseases and protein expression strategies to help team improve engineered cell lines.
- Present status updates and data in multidisciplinary team meetings.
- Comply with standard laboratory practices and company policies.
Requirements:
- B.Sc. or M.Sc. (5+ years industry experience)
- Experience in tissue culture, single cell cloning and screening, cell-based assays, qPCR, western-blotting, ELISA, enzymatic assays and flow cytometry.
- Impeccable record keeping and written documentation.
- Organized, flexible, and able to prioritize.
- Outstanding interpersonal skills and established collaborative working habits.
- Excellent oral and written communication skills
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We are looking for a motivated immunologist with a passion for innovation to develop novel cell-based therapies for the treatment of immune-mediated diseases.
Responsibilities
- Lead a team of 2 scientists.
- Conceive, design, and conduct PoC experiments to generate data that support PK, efficacy & safety of therapeutic products in preclinical models of inflammatory disease.
- Critically analyze and interpret data, able to prioritize experiments and design follow-up experiments leading to project advancement.
- Manage external projects with CROs and external collaborators.
- Regularly communicate and present results to leadership teams
- Development and execution of primary immune cell-based assays for determining the activity of therapeutic proteins
- Open approach, ability, and eagerness to learn novel techniques or analysis tools based on project needs.
- Contribute to optimizing protocols, tools, and/or development of new methods.
- Work collaboratively in a fast-moving, highly interactive matrixed dynamic business environment and changing project portfolios
- Maintain familiarity with scientific and technical literature pertinent to the projects
Requirements
- Ph.D. degree or post-doctoral training in Immunology
- Post-doctoral or Industry experience highly desirable
- Proven track record exemplified by high-quality publications
- Expertise in cell engineering
- Experience in standard immunology assays such as flow cytometry, ELISA etc…
- Experience in executing in vivo studies in pre-clinical models of inflammatory / autoimmune diseases.
- Outstanding interpersonal skills and established collaborative working habits.
- Excellent oral and written communication skills
- Must enjoy coming to work and having fun while creating therapies that improve the lives of patients
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The Quality Assurance (QA) Associate Manager/Manager is responsible for providing quality assurance on-site support at Contract Manufacturing Organizations (CMOs) within the Quality Operations organization. Actively provides CMO on-site operational support and quality assurance oversight related to manufacturing and product release. Acts as a Person in Plant (PIP) during tech transfer and cGMP manufacturing activities and acts as ‘eyes and ears’ for Sigilon internal stakeholders at CMO. Has a working knowledge of GMP quality assurance best practices, non-conformances, CAPA management, vendor collaboration, as well as experience working within a cGMP manufacturing environment. Excellent communication skills and ability to work in a highly interactive and matrixed environment. Presentation of written and oral summaries of progress in team meetings as well as to management is expected.
We seeking candidates based in Pennsylvania/New Jersey only.
Responsibilities:
- Liaise with Sigilon Associate Director of Manufacturing Sciences and Technology (MSAT) onsite PIP,Supply Chain (External Manufacturing, Patient Supply, etc.), Process Development (PD), Project Management for required on-site support at CMO facility manufacturing, product release, non-conformances, and CAPA management
- Provide onsiteCMO support (including shift-hours and some off-hours days to resolve urgent quality issues) during tech transfer activities and leading up to and during cGMP manufacturing and product release
- Review and approval of Master Batch Records (MBR)
- Reviewand approvalofexecutedbatchrecordsfor drug substance /drug product, and CertificateofAnalysis/Testing/Compliance(CoA,CoT& CoC).
- Review of environmental monitoring (EM) processes and data related to Sigilon projects and suites
- Review and track training records of CMO personnel working on Sigilon projects to ensure conformance to CMO SOPs and Client Operating Procedures (COPs)
- Work with External Manufacturing to track CMO performance prior and input on vendor performance as part of the business review process.
- Collaborate with other Sigilon PIP to identify and escalate business-critical issues at CMO affecting Quality, Compliance, Operations and Management
- Perform data integrity verifications from CMO for critical documents such as regulatory IND/BLA filings
- Support the investigation of exceptions and determine root causes, implement CAPAs and drive to closure.
- Assist in the creation and maintenance of Standard Operating Procedures, collaborate with CMO to create and review Client Operating Procedures.
- Vendor audits: schedule, lead vendor audits, prepare audit reports and follow up on audit findings.
- Additional responsibilities as required
Requirements
- B.S./B.A. degree
in a scientific discipline, with 5+ years of previous experience in quality assurance and systems in an FDA regulated or similar environment preferred. - Working knowledge of the relevant industry and government regulations, including 21 CFR 11. cGMP, GDP, CFRs, Annex 13, ICH E6 (R2). Uses industry knowledge to drive best-practices within the company
- Demonstrated project skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams
- Understand comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, CFRs, Annex 13, ICH E6 (R2), etc)
- Experience in interacting with Health and Regulatory Authorities (e.g. inspections)
- Experience in deviation investigation and CAPA implementation
- Possess strong attention to detail and have exceptional interpersonal, organizational, and communication skills
- An energetic self-starter who is adept at multi-tasking, has a track record of productivity, and capable of working both independently and as part of multiple collaborative teams.
- Strong technical background in aseptic operations
- Travel up to 50%
Special considerations:
Candidate must possess effective communication skills and proven abilities in interfacing with colleagues in several different departments and managing multiple projects/priorities. Must be methodical, well organized, and detail-oriented. Individuals must be highly self-motivated, readily adaptable to a fast-paced, multidisciplinary team-based environment, and capable of working autonomously with little direct supervision.
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Sigilon Therapeutics is seeking a proven leader with expertise in pharmaceutical/biotechnology quality assurance, excellent communication skills, and the ability to work independently in a highly interactive and matrixed environment. The incumbent will serve as integral member of the Quality Group, focusing on oversight of Contract Manufacturing Organizations (CMOs), leading vendor audits, review approval of batch records for drug substance /drug product, and Certificate of Analysis/Testing/Compliance (CoA, CoT & CoC). This role will require daily interaction with stakeholders including but not limited to CMC Analytics, Biology, Clinical Operations, Contract Manufacturing Organizations (CMOs), Clinical Research Organizations (CROs), and External Testing Laboratories.
Presentation of written and oral summaries of progress in team meetings as well as to management is expected. Supporting Quality initiatives as well as leading and participating in Quality projects as required.
Responsibilities:
- Vendor Management and Oversight
- Qualification of prospective vendors in accordance with Sigilon GMP tiering; questionnaires, assessments in collaboration with stakeholders.
- Preparation, negotiation, and execution of vendor quality agreements
- Independently manage quality oversight for multiple programs at multiple CMOs concurrently
- Vendor audits: schedule, lead vendor audits, prepare audit reports and follow up on audit findings.
- Initiation, tracking, and approval of CMO non conformances, manufacturing/testing CAPAs, and audit related corrective actions
- In collaboration with internal stakeholders track vendor performance, create KPIs, metrics, and provide updates to senior management on an ongoing basis.
- Quality Management System (QMS) Documentation Oversight and Compliance
- Collaborate with cross functional teams and outside contractors to ensure that relevant Sigilon computer systems are compliant with global regulations including but not limited to FDA 21CFR Part 11, GAMP5, EU Volume 4 GMP Annex 11: Computerized Systems. Assist in development and review of Computer System Validation (CSV) documentation.
- Oversee tech transfer implementation of QMS processes and procedures related to CMOs
- Liaison between CMO and Sigilon for training needs and compliance
- Internal Audits
- Prepare, conduct, and produce reports for process audits of key Sigilon departments and workflows on a scheduled basis to confirm compliance with the established SOPs
- Such audits include but are not limited to CMC Analytics, Biology, Engineering, IT, Manufacturing. Ensure all findings are resolved effectively in a timely manner.
Requirements
- B.S./B.A. Degree
in scientific discipline, with 8+ years of previous experience in quality assurance and systems in an FDA regulated or similar environment preferred. - Demonstrated Computer System Validation (CSV) operational expertise and experience.
- Demonstrated vendor management, auditing operational experience
- Experience with electronic document management systems, quality management systems, and electronic learning management systems (LMS). Working knowledge of relevant industry and government regulations including: 21 CFR 11. cGMP, GDP, CFRs, Annex 13, ICH E6 (R2). Uses industry knowledge to drive best-practices within company
- Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams
- Understand comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, CFRs, Annex 13, ICH E6 (R2), etc)
- Experience in interacting with Health and Regulatory Authorities (e.g. inspections)
- Experience in deviation investigation and CAPA implementation
- Possess a strong attention to detail and have exceptional interpersonal, organizational and communication skills
- An energetic self-starter who is adept at multi-tasking, has a track record of productivity and capable of working both independently and as part of multiple collaborative teams
- Ability to prioritize responsibilities to meet project deadlines and flexibility to react quickly to changing research needs
- Travel up to 25% (post-covid)
- Special considerations:
Candidate must possess effective communication skills, and proven abilities in interfacing with colleagues in several different departments and managing multiple projects/priorities. Must be methodical, well organized and detail oriented. Individual must be highly self-motivated, readily adaptable to a fast-paced, multidisciplinary team-based environment and capable of working autonomously with little direct supervision
- Vendor Management and Oversight
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The Associate Director of Manufacturing Sciences and Technology (MSAT) is responsible for providing manufacturing and materials management on-site support at Contract Manufacturing Organizations (CMOs) within the Supply Chain organization. Actively provides CMO on-site operational support to CMC & Analytics including Supply Chain and Process Development. Acts as a Person in Plant (PIP) during tech transfer and cGMP manufacturing activities and acts as ‘eyes and ears’ for Sigilon internal stakeholders at CMO. Has a working knowledge of manufacturing and supply chain best practices, vendor collaboration, as well as experience working within a cGMP manufacturing environment. Excellent communication skills and ability to work in a highly interactive and matrixed environment. Presentation of written and oral summaries of progress in team meetings as well as to management is expected.
Pennsylvania/New Jersey based candidates prefered.
Responsibilities:
- Liaise with Supply Chain (External Manufacturing, Patient Supply, etc), Process Development (PD), Project Management and Quality for required on-site support at CMO facility for manufacturing and materials management activities
- Provide onsiteCMO support (including shift-hours and some off-hours days to resolve urgent issues), during tech transfer activities and leading up to and during cGMP manufacturing
- In collaboration with PD and other technical staff provides on-floor Person in Plant (PIP) oversight during manufacturing activities
- Provide training to CMO personnel on Sigilon manufacturing, labeling, and distribution processes
- Work with External Manufacturing and Quality to track CMO performance prior and input on vendor performance as part of business revie process
- Identify and escalate business-critical issues at CMO effecting Compliance, Operations and Management
- Collaborate with CMO and internal stakeholders on implementation of processes and changes including but not limited to change controls and impact assessments
- Reviews manufacturing batch records and verifies process data from CMO for critical documents such as regulatory IND/BLA filings
- Support the investigation of exceptions and determine root causes, implement CAPAs and drive to closure. Follow-up of change control ton ensure timely implementation in line with regulatory and stock management constraints
- Lead cross functional projects and process improvements related to supply chain and manufacturing activities
- Assist in the creation and maintenance of Standard Operating Procedures
- Additional responsibilities as required
Requirements:
- MS in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.) is required with minimum 8 years biotech/pharmaceutical cGMP manufacturing experience. An advanced degree (PhD) is preferred
- Certification in Project Management (e.g. PMI certification) and process improvement methodologies (e.g. Six Sigma) is a plus
- Must have prior experience and proficiency in biologics/sterile manufacturing, and a proven track record solving complex technical issues. Experience across the cell therapy supply chain preferred
- Strong technical background in aseptic operations
- Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams
- Understand comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, etc)
- Experience in deviation investigation and CAPA implementation
- Possess a strong attention to detail and have exceptional interpersonal, organizational and communication skills
- An energetic self-starter who is adept at multi-tasking, has a track record of productivity and capable of working both independently and as part of multiple collaborative teams
- Strong collaboration and excellent team skills to be successful in cross-functional environment
- Ability to prioritize responsibilities to meet project deadlines and flexibility to react quickly to changing research needs
- Flexibility to work shift hours required to cover critical process steps
- Travel up to 50%
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Responsibilities:
- Manage team of research associates of various levels and Scientists
- Design studies and work with the team to execute studies for regulatory submissions
- Prepare nonclinical sections of regulatory submissions
- Working with subject matter experts, lead model development specific for different therapeutic areas
- Present and defend study designs at cross-functional team meetings and management meetings
- Coordinate short-term scheduling and long-term planning for in-house and out-sourced studies
- Review contracts and invoices from external vivarium support staff and for out-sourced studies
- In a matrix environment, collaborate with team members and coordinate assigned activities with other teams to ensure timely completion
- Oversee and perform preclinicalin vivo studies in rodents, which require surgery, necropsy, test article administration, and blood and tissue collection for analysis
- Develop/lead development of histology and/or imaging techniques specific to different disease states
- Understand and ensure compliance with IACUC protocols and EHS regulations
- Make observations, evaluate data, interpret results and document in a well-maintained laboratory notebook and study reports in timely fashion
- Comply with standard laboratory practices and company policies
- Participate in discussions to optimize protocols, tools, or methods for project advancement
- Apply relevant scientific literature to the design of experimental protocols
- Present study results of experiments and findings in multidisciplinary team meetings
Requirements:
- PhD in biology, bioengineering, or similar degree + ≥ 7 years industry experience
- M.S. in biology, bioengineering, or similar degree + ≥ 10 years industry experience
- 3+ years managing personnel
- Experience directing biotech/contract research organizations
- Proficiency in rodent handling, blood collection, tissue harvesting and processing of biological samples forex vivo analysis is required
- Experience in rodent surgery, especially laparotomy is highly desirable
- Outstanding sense of urgency, interpersonal skills and established collaborativeworking habitsin a dynamic, matrixed environment
- Excellent oral and written communication skills and time management
- Must enjoy coming to work and having fun while creating therapies that improve the lives of patients
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Sigilon Therapeutics is searching for an energized and highly motivated Assistant/ Associate Scientist to be part of a team focused on developing a novel therapeutic product for Rare Disease utilizing Sigilon’s Afibromer™ technology. The candidate should have experience in CNS, including cell culture experience, functional cellular analyses, sample preparation for analyses of samples from in vivo/ in vitro work.
Responsibilities
- Tissue culture of primary cells and recombinant cell lines
- Perform and interpret data from cell-based assays and molecular biology assays
- Make observations, evaluate data, interpret results and document in a well-maintained laboratory notebook
- Participate in the coordination of assigned research with other teams as necessary to ensure the completion of the team’s research projects
- Comply with standard laboratory practices and company policies
Requirements
- BS or MS degree in the biological sciences
- CNS experience preferred
- Previous experience in industry or academia investigating with rare diseases field, includingsample preparation and analysis from in vitro and in vivo is a plus
- Outstanding interpersonal skills and established collaborative working habits
- Skills in MS Office: Word, PowerPoint, Excel, Outlook
- Ability to work and succeed within a matrixed organization
- Must enjoy coming to work and having fun while creating therapies that improve the lives of patients
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The successful candidate will work in our Rare Disease group and will be working on CNS platform. Developing applications and tools addressing the delivery of proteins cross Blood Brain Barrier. Expertise with some or all the following techniques is essential: cell culture, cell-based assays, RNAi technology, imaging, molecular cloning.
Responsibilities:
- Lead the efforts identifying, researching and developing pipeline indications for Sigilon platform technology.
- Accountable for design, implementation, and interpretation of key go/no-go preclinical experiments directed to advancing new disease areas and indications – both in vitro and in vivo disease models
- Own the relationships with internal and external KOLs.
- Investigate and condense complex disease areas for presentation to leadership.
- Responsible for keeping up with literature and cutting-edge techniques.
Requirements:
- Ph.D. degree required in a biological field of study.
- Experience in CNS is preferred.
- Strong and diverse understanding of disease pathophysiology.
- Experience with cell therapies and in vivo disease models a plus.
- Outstanding interpersonal skills and established collaborativeworking habits.
- Excellent oral and written communication skills.
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Sigilon is a clinical-stage biotechnology company pioneering a new class of therapeutics and seeking to develop functional cures for patients with chronic diseases by providing stable and durable levels of therapeutic molecules to patients. Sigilon has developed its Shielded Living Therapeutics, or SLTx,platform, which combines advanced cell engineering with cutting-edge innovations in biocompatible materials and enables our product candidates to produce a wide range of therapeutic molecules that may be missing or deficient, such as proteins, antibodies and hormones. The company is designing product candidates to be off-the-shelf, durable, controllable and redosable, without requiring modification of the patient’s genes or immunosuppression. The lead product candidate, SIG-001, is designed to prevent bleeding episodes in patients with moderate-severe to severe Hemophilia A by continuously secreting human FVIII. The company received acceptance of its IND submission in the United States in August 2020 and its CTA in the United Kingdom in May 2020. Sigilon initiated a Phase 1/2 clinical study of SIG-001 in Hemophilia A, with the first patient dosed in October 2020.
Job Summary:
The Senior Director/VP, Investor Relations is an important leadership role at Sigilon Therapeutics. This person will report to the Chief Financial Officer and work closely with the CEO and senior management team. S/He will have overall responsibility for shaping the investor communication strategy, manage interactions with buy-side, sell-side and other constituents, with the aim of increasing shareholder value and enhancing Sigilon’s image in the investment community.
Key Responsibilities:
- Work closely with the senior leadership team on the development, integration and execution of the investor relations strategy
- Create and manage a targeting strategy for prospective investors; establish and nurture close relationships with key investors and Wall Street analysts
- Track Wall Street analysts’ models, estimates, and pipeline expectations
- Continual refinement of messaging and market positioning based on company performance, market perception, expectations, peer performance and relative valuation
- Partner with senior leadership and work cross-functionally to support specific investor relation activities and creation of investor communications and events including analyst days, scientific meeting investor events and other investor focused communications
- Originate and maintain investor-facing materials, including all press releases, investor presentations, conference call scripts, Q&As, IR website and backgrounders
- Work in close partnership with internal legal team to review IR-related external communications and related 8-K filings
- Maintain master investor list and target communication lists; Track all investor interactions
- Prepare executive management for investor events and earnings calls; Accompany and support senior executives at investor conferences and be a resource for information; Own and prepare investor presentations and key investor messages by working with multiple functional groups
- Keep abreast of industry trends and competitive landscape to both proactively and reactively adjust plans, messaging and manage relationships that may be impacted
Qualifications:
- 6+ years’ experience in the life sciences industry with a focus on investor relations, finance, equity research or investment banking
- MBA and experience in the life sciences industry /or advanced science degree preferred
- Experience successfully evolving an investor relations strategy as necessary for a rapidly growing and expanding business
- Existing relationships within the financial, industry analyst, media, and institutional investor communities particularly in life sciences
- Capable of independently writing clear, concise and error-free documents; Develop complex documents such as press releases, external company presentations, annual/quarterly reports.
- Impeccable integrity and judgment skills, ability to deal with sensitive financial information and make recommendations to the CEO and CFO
- A proactive, strategic approach to investor relations; Proven ability to plan, organize and execute IR-related events
- Exhibit excellent verbal, interpersonal communications, and business writing skills
- Possess a strong work ethic, be a self-starter, and be able to be highly productive in a dynamic, collaborative environment; Strong attention to detail and ability to be tactical and strategic
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Sigilon Therapeutics is seeking an Assistant/Associate Scientist to specialize in LCMS based analytical support for multiple therapeutic programs across the company.
Responsibilities
- Develop and perform standardized protocols for detecting and quantifying biomarkers for in vivo experiments.
- Operate and maintain high resolution mass spectrometer.
- Biological sample preparation for mass spectral analysis.
- Coordinate with internal molecular biology, biochemistry, and in vivo team members for timely delivery of assay data to support preclinical programs.
- Assess scientific literature in a variety of therapeutic areas to develop and optimize assays.
- Interpret and present experimental data in multidisciplinary team meetings.
Requirements
- BS or MS in chemistry, biology, physics, or related discipline.
- 1 + years of experience in the pharmaceutical/biotechnology industry, specifically in working with analytical instrumentation. Chromatographs and mass spectrometry experience is a plus.
- Strong passion to learn and reach a level of expertise in liquid chromatography as well as mass spectrometry.
- Ability to work independently after necessary training is complete.
- Ability to multitask and complete multiple objectives within a single workday.
- Strong team orientation, with excellent written and oral communication skills.
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Responsibilities:
- Perform preclinical in vivo studies in rodents, which requires surgery, necropsy, test article administration and blood and tissue collection for analysis
- Understand and ensure compliance with IACUC protocols and EHS regulations
- In a matrix environment, collaborate with team members and coordinate assigned activities
with other teams to ensure timely completion - Make observations, evaluate data, interpret results and document in a
well-maintained laboratory notebook and study reports in timely fashion - Comply with standard laboratory practices and company policies
- Work with team leads to evaluate histopathology assays and perform imaging for internal
programs - Participate in discussions to optimize protocols, tools, or methods for project advancement
- Apply relevant scientific literature to the design of experimental protocols
- Present study results of experiments and findings in multidisciplinary team meetings
Requirements:
- B.Sc. degree in biology or similar degree
- 2+ years industry experience working in a vivarium is desirable
- Proficiency in rodent handling, blood collection, tissue harvesting and processing of
biological samples for ex vivo analysis is required - Experience in rodent surgery, especially laparotomy is highly desirable
- Experience in histopathological techniques such as tissue sectioning, staining, and microscopy imaging is a plus
- Outstanding sense of urgency, interpersonal skills and established collaborative working habits in a dynamic,
matrixed environment - Excellent oral and written communication skills and time management
- Must enjoy coming to work and having fun while creating therapies that improve the lives of patients