Job Opportunities

Current Openings

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
Apply Now
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
Apply Now
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
Apply Now
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
Apply Now
Sigilon Therapeutics is searching for an energized and highly motivated 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 rare disease, 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 enzymatic, 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
Sample 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
Apply Now
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
Apply Now
Sigilon is looking for an experienced process development scientist to join our team focused on developing a novel therapeutic product for diabetes utilizing Sigilon’s Afibromer™ technology combined with leading edge pancreatic islet cell technology. Key objectives will be to develop robust and scalable cell therapy bioprocesses and transfer these processes to contract manufacturing partners.
KEY RESPONSIBILITIES
· Execute manufacturing process development to scale up iPSC expansion, differentiation
and encapsulation in collaboration with biology and engineering development teams.
· Development of SOPs, batch records and training documents and tech transfer processes to manufacturing partners
· Analyze process data to identify trends and to evaluate and identify critical process
parameters
· Collaborate with Quality, Supply Chain and Regulatory functions to ensure processes,
reagents and ancillary materials are aligned with cGMP and regulatory
requirements.
· Contribute to authoring and assembling CMC sections of regulatory filing(s) as needed.
· Periodically traveling to CMOs, CROs and collaboration partners as needed for training or
Person in Plant oversight.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
· BS/MS in chemistry, biology, engineering or a related discipline with 5+ years
biologics and/or cell therapy process development experience or Ph.D. with 2
years relevant experience
· Significant experience with a variety of mammalian cell culture technologies and
operations, pluripotent stem cell therapy specific experience preferred,
including industry experience with cell therapy process development desired
· Hands-on experience with Quality by Design – Design of Experiments (DoE’s) and how it
can be applied to cell therapy bioprocessing
· Strong analytical skills to perform statistical analysis as well as proficiency in
statistical software (R, JMP, Minitab)
· Breadth of knowledge across bioprocessing technologies, cell characterization method
development, GLP/GMP experience, strongly desired
· Working knowledge of biologics CMC regulations and cGMP requirements, as well as,
experience in supporting regulatory filings
· Demonstrated success in delivery of a complex therapeutic program into the clinic desired
· Innovative, critical and creative thinker, unafraid to propose aggressive solutions to
complex problems
· Excellent communication and collaboration skills, comfortable working in a matrix
environment

Apply Now
Sigilon is looking for an experienced process development scientist to join our team focused on our platform of novel therapies utilizing Sigilon’s Afibromer™ technology. Key objectives will be to develop robust and scalable cell therapy
bioprocesses with an emphasis on supporting regulatory filings and tech transfer to external manufacturing partners.

KEY RESPONSIBILITIES

· Execute manufacturing process development to scale up expansion of adhesion-dependent
cells in collaboration with biology and engineering development teams

· Development of SOPs, batch records and training documents and tech transfer processes to
manufacturing partners

· Design experiments and analyze data to ensure process robustness

· Collaborate with Quality, Supply Chain and Regulatory functions to ensure processes,
reagents and ancillary materials are aligned with cGMP and regulatory
requirements

· Contribute to authoring and assembling CMC sections of regulatory filing(s) as needed

· Manage sample submission, report writing, and proper documentation for in vivo
studies

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

· BS/MS in chemistry, biology, or engineering or a related discipline with 5+ years
biologics and/or cell therapy process development experience or Ph.D. with 2
years relevant experience

· Strong background in statistical analysis and familiarity with statistical software
packages (Prism, Matlab, R, JMP, or similar)

· Good mammalian cell culture technique and aseptic processing, preferably with
experience working with a variety of cell culture equipment such as cell
counters, metabolite analyzers, and similar

· Experience in cryopreservation is a plus

· Experience with project management is a plus

· Excellent communication and collaboration skills, comfortable working in a matrix
environment

· Working familiarity with cGMP requirements

Apply Now
Sigilon Therapeutics is looking for an experienced process development scientist to join the team responsible for enhancing and evolving the manufacturing process for Sigilon’s encapsulated allogeneic cell therapy platform. Key objectives will be to develop robust and scalable cell therapy bioprocesses and transfer these processes to contract manufacturing partners.
KEY RESPONSIBILITIES
- Design and execute process development laboratory studies that support the evaluation, development and implementation of new technologies for cell therapy manufacturing.
- Perform hands-on lab-based activities in a cell culture lab, including analysis and communication of results to cross-functional teams.
- Perform process or equipment analysis and trend process or equipment performance.
- Provide process training to GMP personnel.
- Support technology transfer and GMP manufacturing operations as needed.
- Perform statistical analysis including design of experiments (DOEs) as appropriate.
- Write and review technical documentation, technical SOPs, draft manufacturing batch records, technical reports and summary reports.
- Support qualification and risk assessment activities for GMP implementation.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS
- BS in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with 3+ years biologics manufacturing & process development experience required. Cell therapy specific experience preferred
- Strong analytical skills to perform statistical analysis as well as proficiency in statistical software (R, JMP, Minitab)
- Established cell culture lab techniques and aseptic processing in a BSC such as cell passaging, sampling, fluid handling, media formulation, managing reagents, and cryopreservation.
- Mastery of scientific and engineering principles related to upstream bioprocessing including scale-up / scale-out approaches, hydrodynamics, mass transfer, and bioreactor design and monitoring is desired
- Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
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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
Apply Now