Current Openings
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Sigilon is seeking a highly strategic Associate Director / Director to join the Human Resources team. Reporting to the Chief Human Resources Officer, this individual will be responsible for aligning all human resources strategies with business strategies and successfully implementing critical people initiatives. This individual will also be responsible for creating and executing a talent acquisition strategy to identify, attract and hire qualified talent. Candidates should have experience leading high-impact human resources initiatives, partnering with business leaders and providing day-to-day human resource support to employees.
Responsibilities
- Partner closely with leadership, employees, external partners and key stakeholders to develop and execute various human resource strategies.
- Coach, counsel and advise leadership on all human resources issues with broad subject matter expertise.
- Develop and implement competitive career development programs and policies.
- Develop and implement recruiting strategies that support Sigilon’ s projected growth.
- Lead all company-wide recruitment efforts.
- Partner with hiring managers to develop job descriptions and interview strategies.
- Evaluate Sigilon’s talent pool and ensure that effective succession plans are in place.
- Facilitate the annual talent review processes and continuously evaluate those processes.
- Encourage diversity and inclusion through formal programs and support.
- Develop and implement industry-leading approaches to sustain and enhance employee engagement.
- Lead initiatives to sustain and enhance Sigilon’s culture and employee value proposition.
- Create HR policies and processes that align with Sigilon’s culture.
- Partner on compensation and benefits as needed to ensure competitive market position.
- Ensure an effective performance review cycle by partnering with leadership and employees to set and evaluate performance goals.
- Provide day-to-day performance management guidance to managers, including coaching, counseling, career development etc.
- Support Employee Relations Efforts.
- Analyze metrics and identify critical people-related trends.
- Ensure compliance with all relevant employment laws and regulations.
- Collaborate closely with Finance and Legal as needed.
- Prepare and present analyses, materials and recommendations to leadership as needed.
Qualifications
- Bachelor’s degree; Master’s degree (preferred)
- SHRM certification preferred
- 8+ years of experience in key human resources functions (e.g., talent, engagement, employee relations, organization effectiveness, compensation & benefits, performance management, etc.)
- Proven experience in Talent Acquisition preferably in the biotech industry
- Demonstrated experience acting as a strategic partner to the business
- Demonstrated ability to support staff and manage conflicts
- Excellent written and verbal communication skills
- High level of emotional intelligence
- Ability to thrive in a fast-paced environment
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Sigilon Therapeutics is seeking an individual with expertise in pharmaceutical/biotechnology quality assurance, excellent communication skills, and the ability to work in a highly interactive and matrixed environment. The incumbent will serve as integral member of the Quality Group, focusing on implementation, maintenance, and oversight of QMS documentation, administration of the corporate training program, deviation and CAPA management, and internal auditing. This role will require daily interaction with stakeholders including but not limited to Chemistry, 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:
- Quality Management System (QMS) Documentation Oversight and Compliance
- Manage implementation, management, and maintenance for all QMS procedural documents for all operational departments and acquisitions including archive and electronic storage of original signature documents.
- 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.
- Initiate and drive to completion the review/revision of all QMS documents per quality plans and schedules.
- Assume primary authorship or major contributor for specific procedural revisions as assigned.
- Batch record and C of A review and release
- Administration of corporate training program (in collaboration with department heads) involves the following activities:
- In collaboration with department heads, monitor global compliance to Corporate Training Policy and implement needed corrective and preventive actions
- Maintain role-based definitions of training requirements, enroll staff in computer-based-training programs, track staff training compliance to completion
- Report and escalate training non-compliance to senior management as applicable
- Support audit requests for training records including review of training and ad hoc corrections to those requested records as necessary.
- 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 Chemistry, Biology, Engineering, IT, Manufacturing. Ensure all findings are resolved effectively in a timely manner.
- External Audits
- Prepare, conduct, and produce reports for process audits of key Sigilon suppliers/vendors on a scheduled basis to confirm compliance to relevant global regulatory regulations, master and quality agreements
- Such audits include but are not limited to CROs, CMOs and External Testing Laboratories
- Ensure all findings are resolved effectively in a timely manner.
Requirements
- B.S./B.A. Degree
in scientific discipline, with 3+ 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.
- 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 10%
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.
- Quality Management System (QMS) Documentation Oversight and Compliance
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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:
- Maintain and set up devices for biopolymer encapsulation systems.
- Perform established protocols for encapsulation of cells in novel biopolymer systems, cell-based functional assays, and associated biomaterial characterization assays.
- Perform proper sterile technique when making materials. Knowledge of tissue culture of primary cells and cell lines is desired.
- Work in a matrixed environment tomakebiomaterialsfor preclinical studies associated with all developmental cell therapy programs.
- Make observations, evaluate data, and interpret and document results in a well-maintained laboratory notebook.
- Establish and participate in discussions to optimize protocols, tools, and/or new methods for project advancement.
- Collaborate with other team members and cross-functional teams to ensure the completion of projects and advancement of pipeline programs.
- Demonstrate understanding and application of relevant scientific literature to help design experiments.
- Present experimental results and findings in multidisciplinary team meetings.
- Comply with standard laboratory practices and company policies.
Requirements:
- B.Sc. or M.Sc. degree with a focus in chemical, biomedical, electrical, or mechanical engineering, biotechnology, or biology
- 1+years of industry experience is desirable
- Experience inbiomaterials,tissue engineering,microfluidic systems integration, or working in a regulated environment desirable
- 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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Sigilon Therapeutics is seeking a Sr Manager to join the CMC Analytical Development group, which performs and manages analytical development activities to support Sigilon’s program and platform development across drug products, drug substances, intermediates, and starting materials.
Responsibilities
- Manage/Perform method development, optimization, qualification, and validation at CDMOs
- Manage/Perform method development, optimization, qualifications, and validations using internal resources
- Review/Author test procedures, qualification protocols and reports
- Develop/Review other analytical relevant batch production documents: specifications, sampling plans, and batch CoAs etc
- Manage/Establish stability programs: Review/Author stability protocols and reports; trend stability data; assess shelf life etc.
- Manage/Establish reference materials: review CoTs, manage retests, characterizations, and qualifications
- Manage analytical perspectives in raw/starting materials
- Analyze, interpret, and present technical and project contents in multidisciplinary team meetings
- Maintain detailed records in electronic laboratory notebook or other formats following quality guidelines
Requirements
- BS/MS/phD degree in biology, chemistry, or other relevant discipline
- Must have at least 5 years of industrial experience in pharmaceutical and/or biotechnology
- Desired to have experience in cell and gene therapy or biologics
- Must have extensive experience working in a GMP environment
- Must have extensive experience working in the analytical development and quality control space
- Desired to have hands-on experience developing cell-based assays, biosafety assays, or medical device assays
- Must have strong attention to details
- Must be able to set priorities and multi-task activities to effectively manage workflows and deliverables
- Desired to have experience working in a multi-disciplinary CMC team
- Must have strong knowledge and keep up to date with industry and regulatory guidelines to direct technical and strategic decisions
- Good written and oral communication skills
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TheAssociateManager / Managerof External Manufacturing is responsibleforsupporting theoversight ofContract Manufacturing Organizations (CMOs) within the Supply Chain organization.Actively overseesCMOactivitiestoensurethe successful CMO supply of product andisaccountable forachieving operational and business goals. Has a workingknowledge ofSupply Chainbest practices, vendor oversight, as well as experienceworking within a cGMP environment.Excellentcommunication 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. Responsibilities:
· OverseesCMOsactivities;including but not limited to:
Managing quotationand purchase ordersetup
Trackbudgetand ongoing spendfor contracted activities
SupportCMOBusiness Reviewsand monitor and report performance according to KPIs
Facilitate regular project meetings with CMOs and internal stakeholders(CMC &Analytics and Supply Chain leadership, Quality, Project Management)
Ensure processes between Sigilon and CMOs arefunctional and efficient
Identifies risks and related mitigations or corrective actions
· Create and oversee CMO level supply plans and production schedules (e.g. capacity, forecast, material inventory) to deliver timely product. Identifies supply constraints and leads timely resolution of issues. Monitor schedule adherence of product schedules and make course corrections if needed
· Ensure effective communication andcoordination betweenCMOs andstakeholders(e.g.CMC & Analytics, Quality, Project Management)so thatproduct/project needsfortech transfer, cGMP manufacturing,and decommissioning are defined and met
· Support theinvestigation 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
· Coordinateproduct and material shipment betweenCMOs. Acts as backup for shipments from CMO to clinical sites
· Ensure ProductSecurityrequirements at CMOs are implemented and maintained
· Develop supply strategies to maximize supply efficiency, while identifying risk and developing risk mitigation plans
· Lead cross functional projects and process improvements related to Supply Chain
· Assist in the creation and maintenance of Standard Operating Procedures
· Additional responsibilities as required
Requirements:
· BS in the relevant Engineering, Science, or related field is required with minimum5years biotech/pharmaceutical cGMP manufacturing experience.
· Certification in Project Management (e.g. PMI certification) and process improvement methodologies (e.g. Six Sigma) is a plus
· Must have prior experience and proficiencyinsmallmoleculeand/orbiologics/sterilemanufacturing, and a proven track record solving complex technical issues.Experience across the cell therapy supply chain preferred
· 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,etc). Knowledge of product security programs
· Experience in interacting with Health Authorities (e.g. inspections)
· Experience in deviation investigation and CAPA implementation
· Strong negotiation skills
· 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 to25%
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Responsibilities: Tissue culture of primary cells and cell lines Stable transfection and selection of engineered cell lines Perform functional and viability cell-based assays Molecular and cell biology techniques, including ELISA, western blot, and PCR - Work in a matrixed environment to insure engineered cell lines meet the needs of the in vivo and cell biology teams
- With increasing independence, plan, design and execute of a series of experiments that provide the research findings necessary for the completion of an assigned project
- Demonstrate understanding and application of relevant scientific literature to the design of experimental protocols
- Participate in discussions on optimizing protocols, tools, programs and/or new methods for project advancement and make the approved changes
- Make observations, evaluate data, interpret results and document in a well-maintained laboratory notebook
- Present results of experiments and findings in multidisciplinary team meetings
- 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: - B.Sc. or M.Sc. degree with a focus on molecular and cellular biology
- 1+ years industry experience desirable
- Experience in tissue culture, cell-based assays, qPCR, western-blotting, ELISA, and flow cytometry
- 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 Clinical Trial Associate (CTA) is a key role that supports directly senior Clinical Operations staff responsible for the planning, execution and management of in-house or outsourced clinical trials. The successful candidate will perform daily clinical trial execution activities associated with the conduct of investigational clinical studies. He/she must exercise discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks. Strong organizational skills are required, as well as the ability to balance changing priorities.
Responsibilities:
- Key support role to senior Clinical Operations staff; ensures that delegated components of clinical trials are executed to expected and specified quality standards
- Schedule and coordinate study meetings, materials and agendas; record and disseminate decisions and actions
- Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
- Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
- Create and maintain the Trial Master File and electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs.
- Participate in drafting and coordinate review of site documents e.g. ICF, advertising materials
- Collect, review, file and/or track clinical trial associated documents and regulatory packages
- Assist in developing study plans, including Lab Manual, Clinical Monitoring Plan, Study Plan, Study Vendor Oversight Plan, Pharmacy Manual, and other. Monitor compliance to plans.
- Work directly with study sites including performing site training, review of site study packets and study files
- Assist in responding to Data Correction Forms (DCFs) and track DCF follow-up and completion activities.
- Support investigational product supply logistics.
- Responsible for study laboratory sample management, including tracking and vendor management support
- Coordinate and track clinical trial equipment and supplies.
- Assist with site budget process.
- Review and track vendor invoices against contracts and coordinate approval.
- Act as central point of communication with study sites and vendor personnel.
- Assist in the creation and updating of standardized clinical trial tools, processes, and SOPs
- Maintain and ensure all documentation is in a state of audit readiness.
- Assist in the coordination of Investigator Meetings.
Requirement/Qualifications:
- Bachelor’s degree in life sciences or healthcare related field
- At least 2+ year experience in clinical operations within sponsor company, CRO or investigational site strongly preferred. Ideal candidate will have experience with gene/cell therapy product
- 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
- Solid understanding of the responsibilities and needs of other functions in a clinical trial
- Experience working closely with study sites, Key Opinion Leaders (KOLs) and external vendors
- Experience with eTMF; ability to directly apply essential document knowledge to file documents
- Proficient in MS Excel, Outlook, Word and PowerPoint. Knowledge of MS project preferred.
- Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
- A team player that takes initiative and has proven ability to work independently and effectively handle multiple priorities in a fast-paced environment.
- Excellent interpersonal/team skills, strong organizational skills
- Proficient written and verbal communication skills.
- Strong customer service
- Strong attention to quality/detail
- Ability to maintain confidentiality of proprietary information expected.
- Position may require some travel.
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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
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Responsibilities:
- Manage team of research associates of various levels
- 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
- Working with subject matter experts, assist in model development specific to therapeutic areas
- Perform preclinicalin vivo studies in rodents, which require 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
- 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.S. degree in biology, bioengineering, or similar degree
- 3+ years managing personnel
- 7+ years industry experienceworking in a vivariumdesirable.
- Experience directing biotech/contract research organizations
- Experience with histology and/or imaging techniques and model development desired
- 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
- 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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We are look for a motivated individual with a passion for innovation to develop novel cell-based therapies for treatment of chronic metabolic and immune-mediated diseases.
Responsibilities :
- Lead therapeutic programs from stages of early exploration through pre-clinical development.
- Conceive, design and conduct PoC experiments to generate data which support PK, efficacy & safety of therapeutic products in preclinical disease models.
- 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
- Open approach, ability, and eagerness to learn novel techniques or analysis tools based on project needs.
- 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 in Cell Biology / Immunology or Endocrinology
- Experience in pre-clinical models of immune or metabolic disorders, development of biomarker assays and leading programs.
- Post-doctoral or Industry experience highly desirable
- Proven track record exemplified by high-quality publications
- 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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Sigilon Therapeutics is searching for a high energy candidate to manage CMC regulatory activities for its early and late phase genetically modified cell therapy products, to advance its Shielded Living Therapeutics encapsulated platform.
Responsibilities:
- Leads CMC RA as a member of cross-functional project teams, responsible for ensuring global strategies are successfully prioritized and executed across early phase and pre-BLA/MAA programs.
- Demonstrated ability to plan, execute, and manage CMC RA components of IND/CTA, including vendor management and writing/review of key module 3, IMPD sections, and related CMC documentation and quality processes.
- Responsible for defining CMC content (data and documentation) requirements for regulatory submissions and writing/reviewing this content for conformance with established requirements, including GMP and EMA/FDA/ICH/WHO/Global regulations and guidelines.
- In collaboration with RA Director and vendors, communicates and negotiates directly and indirectly with FDA, EMA, and international Health Authorities.
- Develops constructive relationships with and proactively communicates CMC RA issues to key internal and external colleagues, management, CROs, regulatory service vendors, and other subject matter experts, exercising sound judgement and ability to negotiate complex challenges that may arise in biologics product development.
- Stays abreast of current and evolving regulatory CMC requirements for cell and gene therapy, and applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development.
- Provides regulatory CMC expertise for new business development/due diligence and organizational QA/RA activities.
Requirements:
- A proven track record in the delivery of complex biologics CMC RA projects for FDA, EMA, and/or other Global Health Authorities
- Experience managing CMC RA projects within a multidisciplinary/cross-functional teams
- A self-motivated team player who tackles challenges with creative and innovative solutions
- Enthusiastic about advanced therapeutic discovery and development
- Experience in taking a product from concept through to launch including scale-up and transfer to manufacture
- Excellent oral & written communication skills
- Experience in complex biologics, vaccines, cell therapy, and/or gene therapy required; combination products experience desirable
- Advanced degree (M.S./Ph.D.) within an engineering or scientific discipline is a plus
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The Vice President, Bioanalytical & CMC Analytical Development will lead all analytical development activities at Sigilon. This includes the development and qualification of bioanalytical, in-process, product release, and raw material release assays. In this role you will direct a highly functioning group tasked with developing, qualifying, and transferring methods for our platform encapsulated cell therapy products. Sigilon Therapeutics is searching for an energized and highly motivated leader to evolve this function to support our rapidly advancing portfolio of Shielded Living Therapeutics™. We are interested in candidates with a proven track-record of analytical technical excellence and are looking for a strong leader with a dedicated focus on developing organizations and growing future leaders.
Primary Responsibilities- Build and execute a comprehensive bioanalytical & analytical development strategy
- Work with Pre-Clinical Development, CMC, Quality, Regulatory, Clinical, and Project Management functions to align bioanalytical & analytical development strategy with program, portfolio, and corporate goals
- Develop, qualify and transfer analytical/bioanalytical methods used in Sigilon’s nonclinical, clinical, and CMC testing operations supporting in-process, release, characterization and stability testing
- Write, review and / or approve analytical specifications, method qualification protocols, and technical reports
- Effectively prioritize and coordinate assay development efforts across programs and deliver high-quality results on tight timelines
- Manage the functional component of business planning and budget accountability for the function
- Build processes and relationships with CROs and other external development, testing, and manufacturing organizations to support assay development, qualification and sample testing
- Author relevant nonclinical, clinical and CMC sections for regulatory submissions and other related Health Agency interactions; work with Regulatory team to respond to information requests in a timely fashion
- Foster and maintain a positive culture built around compliance and empowerment, that keeps the needs and safety of the patient at its core
Requirements/experience with:- A Ph.D. in engineering or life sciences with 10+ years of experience or Master's degree with 15+ years of experience in team leadership roles overseeing Bioanalytical and / or CMC Analytical Development organizations, preferably in biologics and cell & gene therapy
- Deep understanding of a wide range of analytical and bioanalytical testing methods; experience with bleeding disorders and/or lysosomal storage disease analytical development highly desired
- Experience with analytical method development, qualification, validation and transfer, as well as product characterization and analytical comparability
- Proven ability to lead an analytical program through development, clinical initiation and marketing authorization desired
- Fundamental understanding of GCLP and cGMP requirements
- Strong interpersonal skills with the ability to effectively collaborate, motivate others, influence and negotiate conflict situations
- A keen ability and desire to grow an organization, mentor our next level leaders, and help manage the dynamics of change
- Energetic, flexible, collaborative, and proactive leadership and management skills to grow and develop a diverse team
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills
- Able to work in a fast-paced and dynamic environment with competing priorities; successfully drive projects forward to meet program/project deliverables
- Excellent communication skills including presentations to stakeholders and leadership
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We are look for a motivated immunologist with a passion for innovation to develop novel cell-based therapies for the treatment of immune-mediated diseases.
Responsibilities
- Conceive, design and conduct PoC experiments to generate data which support PK, efficacy & safety of therapeutic products in preclinical models of inflammatory disease.
- Develop and independently execute immunological and biochemical assays needed to determine immunogenicity.
- Conducting ex vivo experiments to assess function of different immune cell types, such as T cells and NK cells or dendritic cells
- Development and execution of human primary immune cell-based assays for determining activity of therapeutic proteins
- 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
- 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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Sigilon Therapeutics is searching for an energized and highly motivated Sr. 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 tissue culture of cell lines and with cell and molecular biology assays.
Responsibilities
- Tissue culture of cell lines and pluripotent stem cell lines
- Reagent preparation, lab organization and daily maintenance of long-term experiments
- Perform cell-based and molecular biology assays, including cell viability, flow cytometry, qPCR, and functional assays
- Make observations, evaluate data, interpret results and document in a well-maintained laboratory notebook
- Present results of experiments and findings in multidisciplinary team meetings
- 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
- Sc. with 3+ years industry experience or M.Sc. degree with 2+ years industry experience with a focus on biology, molecular biology or cell biology
- At least 2 years laboratory experience in industry or academia desirable
- Experience in tissue culture and cell-based and molecular biology assays, e.g. qPCR, immunohistochemistry, ELISA, and flow cytometry a plus
- Organization, attention to detail, willingness to learn new techniques and scientific curiosity a must
- 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