Courage to create something that matters

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We are ONE.
We, TOGETHER, are Sigilon.

We care deeply about patients’ and caregivers’ struggles, stories, and triumphs.

We care about rigorous science addressing critical patient needs

We strive to earn and keep the trust of patients, caregivers, and partners.

We respect each other, embrace diversity, and work as one team.

We are passionate about the impact of groundbreaking discoveries.

We dream big and don’t fear failure. We ask “What if we could…?”

We build value for patients and their families, clinicians, partners, and shareholders.

We make sure every experiment and decision counts.

We visualize success and make it happen.

We operate with urgency; patients can’t wait.

Always Growing

We are change-makers, and we never stop in our quest to advance therapies for patients in need. For us that takes a number of forms — we stay abreast of the most recent Sigilon science at our Sigilon Monthly Sessions, where a team member presents their findings and cross-pollination of ideas is encouraged; we also meet up informally, around the weekly Friday breakfast or in our collaboration hubs outside the lab. In this way, we’re always inspiring one another and advancing science that matters.

Never Losing Sight of Our Purpose

We’re at Sigilon to make a difference for patients, and that is front and center in our day to day work. We host patients and caregivers at our offices to learn more about the disease areas we aim to treat. And we stay engaged with the broader community, from organizing a fundraiser to send young people to the New England Hemophilia Association Family Camp, to sponsoring rare disease awareness efforts.

Enjoying Our Relationships

From our Sigilon running team to occasional yoga outings to escape rooms and offsite retreats, we really enjoy our teamwork in all forms. We are a close-knit team with an upbeat atmosphere, and it shows in our productive science — a true team effort.

Life at Sigilon

We have an amazingly collaborative team; we really like each other and this makes working together enjoyable.

Lori

Office Manager/Executive Assistant

I love that we have a fast-paced scientific workplace but where people are so approachable and friendly.

Guillaume

Associate Director

Current openings

Sigilon Therapeutics is seeking an individual with broad expertise in external manufacturing, excellent communication skills, and the ability to work in a highly interactive and matrixed environment. The incumbent will oversee Contract Manufacturing Organizations (CMOs) for MCB, Cell Expansion, and Sigilon’s Shielded Living Therapeutics™ encapsulation, and labeling; including managing the business relationship, negotiating contracts, ensuring the successful CMO supply of product, and achieving operational and business goals. The successful candidate will also assist in managing distribution between CMOs. This role will require daily interaction with stakeholders including but not limited to Regulatory, Quality, TechOps (Manufacturing, Supply Chain, Process Chemistry, Device & Delivery Engineering, CMC Analytics, Materials Engineering, etc). Presentation of written and oral summaries of progress in team meetings as well as to management is expected. This employee will operate a diverse array of development, manufacturing, and analytical equipment and maintain a safe laboratory environment.

Responsibilities:
- Oversee and manage the relationship of CMOs for MCB, Cell Expansion, and Sigilon’s Shielded Living Therapeutics™ encapsulation, and labeling; including but not limited to:
Participates and contributes in CMO selections and evaluates a CMO’s capacity and capability as an input to a sourcing decision. Supports Quality and TechOps on vendor qualification activities

Managing contract setup, negotiation, and maintenance (in collaboration with TechOps, Quality, and Legal)

Manage budget and ongoing spend for contracted activities

Establish and lead Quarterly Business Reviews and monitor and report performance according to KPIs

Facilitate regular project meetings with CMOs and internal stakeholders (TechOps, Quality, Project Management)

Managing and solving potential disagreements, contract breaches etc. (in collaboration with TechOps, Quality, and Legal)

Ensure processes between Sigilon and CMOs are functional and efficient
- 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 and coordination between CMOs and stakeholders (e.g. TechOps, Quality, Project Management) so that product/project needs for tech transfer, cGMP manufacturing, and decommissioning are defined and met
- 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
- Oversee labeling activities at CMOs and ensure labels are in compliance to regulations
- Coordinate product and material shipment between CMOs. Acts as backup for shipments from CMO to clinical sites
- Ensure Product Security requirements 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 minimum 6 years biotech/pharmaceutical cGMP manufacturing experience. An advanced degree (MBA, MS, or 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
- 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 to 50%
Apply Now
Sigilon Therapeutics is seeking an individual with broad expertise in external manufacturing, excellent communication skills, and the ability to work in a highly interactive and matrixed environment. The incumbent will oversee Contract Manufacturing Organizations (CMOs) for small molecule, alginate, and Sigilon’s Afibromer™; including managing the business relationship, negotiating contracts, ensuring the successful CMO supply of product, and achieving operational and business goals. The successful candidate will also assist in managing distribution between CMOs. This role will require daily interaction with stakeholders including but not limited to Regulatory, Quality, TechOps (Manufacturing, Supply Chain, Process Chemistry, Device & Delivery Engineering, CMC Analytics, Materials Engineering, etc). Presentation of written and oral summaries of progress in team meetings as well as to management is expected. This employee will operate a diverse array of development, manufacturing, and analytical equipment and maintain a safe laboratory environment.

Responsibilities:
- Oversee and manage the relationship of CMOs for MCB, Cell Expansion, and small molecule, alginate, and Sigilon’s Afibromer™; including but not limited to:
Participates and contributes in CMO selections and evaluates a CMO’s capacity and capability as an input to a sourcing decision. Supports Quality and TechOps on vendor qualification activities

Managing contract setup, negotiation, and maintenance (in collaboration with TechOps, Quality, and Legal)

Manage budget and ongoing spend for contracted activities

Establish and lead Quarterly Business Reviews and monitor and report performance according to KPIs

Facilitate regular project meetings with CMOs and internal stakeholders (TechOps, Quality, Project Management)

Managing and solving potential disagreements, contract breaches etc. (in collaboration with TechOps, Quality, and Legal)

Ensure processes between Sigilon and CMOs are functional and efficient
- 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 and coordination between CMOs and stakeholders (e.g. TechOps, Quality, Project Management) so that product/project needs for tech transfer, cGMP manufacturing, and decommissioning are defined and met
- 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
- Oversee labeling activities at CMOs and ensure labels are in compliance to regulations
- Coordinate product and material shipment between CMOs. Acts as backup for shipments from CMO to clinical sites
- Ensure Product Security requirements 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 minimum 6 years biotech/pharmaceutical cGMP manufacturing experience. An advanced degree (MBA, MS, or 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 pharmaceutical/sterile manufacturing, and a proven track record solving complex technical issues
- 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 to 50%
Apply Now
We are look for a motivated immunologist with a passion for innovation to develop novel technologies to optimize and regulate production of therapeutic proteins in vivo.

Responsibilities
- Conceive, design and conduct experiments to monitor and modulate immune responses to implanted cells and their products
- Tissue culture of primary cells and cell lines at scales from cloning to bulk production
- Stable transfection and selection of engineered cell lines
- Manage external projects with CROs and external collaborators.
- Work in a fast moving, highly interactive matrixed dynamic business environment and changing project
  portfolios
- Participate in discussions on optimizing protocols, tools, programs and/or new methods for
  project advancement and make the approved changes
- Present results of experiments and findings in multidisciplinary team meetings
Requirements
- Ph.D. degree in Immunology
- Minimum of 2 years industry experience required.
- Experience in standard immunology assays such as 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
Apply Now
Responsibilities:

· Encapsulation of cells in novel biopolymer systems

· Maintenance and setting up of biopolymer device encapsulation systems

· Establishing protocols and SOPs for encapsulation procedure

· Work in a matrixed environment to ensure biomaterials 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 biomaterials, engineering, biochemistry or biology

·0-2 years industry experience desirable

· Experience in biomaterials, 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 patient lives

Apply Now
Sigilon Therapeutics is seeking an individual with broad expertise in in-vivo and translational biology, excellent communication
skills, and the ability to work in a highly interactive and matrixed environment.

Responsibilities:

• The position is a hands-on, laboratory-based role.

• Conduct in-vivo studies in rodents which requires surgical implantation, dosing, necropsy, blood and tissue collection

• Coordinate in vivo pharmacology research in a matrixed environment, as well as external academic collaborations and an extensive network of CROs

• Interprets data independently, identifies complex technical issues, and implements solutions under supervision

• Supports technology transfer through rigorous documentation, writing and consolidating technical documents.

• Conduct literature research and independently develop disease or surgical models

Requirements:

• B.Sc., M.Sc. in biology or similar degree with minimum 5 years industry experience

• Experience working with CROs to carry out pharmacology, toxicology and PK/PD studies

• Must have prior experience and proficiency in drug substance administration, blood collection, tissue harvesting and processing of biological samples

• Experience with rodent surgery is a plus

• 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

Apply Now
Sigilon Therapeutics is seeking an individual with broad expertise in in-vivo and translational biology, excellent communication
skills, and the ability to work in a highly interactive and matrixed environment.

Responsibilities:

• The position is a 70% hands-on, laboratory-based role.

• Demonstrate understanding and application of relevant scientific literature to the design of experimental protocols, work with therapeutic leads to develop disease or surgical models

• Establish study protocols, IACUC protocols, internal SOP

• Make observations, evaluate data, interpret results and document in a well-maintained laboratory notebook, authoring study reports

• Present results of experiments and findings in multidisciplinary team meetings

• Coordinate in vivo research with other teams as necessary to ensure the completion of the team’s research projects

• Conduct and coordinate in vivo research in external academic collaborations and an extensive network of CROs

• Conduct hands-on in-vivo studies in rodents which requires surgical implantation, dosing, necropsy, blood and tissue collection

• Comply with standard laboratory practices and company policies

Requirements:

• Ph. D in biological sciences or M.Sc. with a minimum of 5 years industry experience.

• Experience working with CROs to carry out pharmacology, toxicology and PK/PD studies

• Must have prior experience and proficiency in drug substance administration, blood collection, tissue harvesting and processing of biological samples

• Experience with rodent and large animal surgery is a plus

• 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

Apply Now
The intern will be responsible for performing methods to develop and characterize devices and/or delivery methods. The successful candidate will also assist in the development and characterization of biomaterial-based tissue scaffolds. This role will require daily interaction with stake holders in engineering, biology, in vivo, regulatory, and clinical teams. Presentation of written and oral summaries of progress in team meetings as well as to management is expected. This employee will operate a diverse array of development,
manufacturing, and analytical equipment and maintain a safe laboratory environment.

Responsibilities:

· Design and perform experiments with biomaterials and biomaterial treatments

· Evaluate surface characteristics via known assays

· Develop assays for material characterization

· Perform or participate in biological assay completion to determine the effects of biomaterial treatments

· Assess data, develop logical next steps, and present to science leadership

· Participate in regulatory document preparation

Requirements/experience with:

· Currently pursing PhD in mechanical or biomedical engineering or closely related field

· Understanding of medical device design, biomaterials, and regulatory approval processes

· Familiarity with various implantable biomaterials, and their properties and characterization

· Understanding of sterilization methods

· Outstanding interpersonal skills and established collaborative working habits

· Excellent oral and written communication skills

· Must be available to start work in the immediate future

· Must have authorization to work in the United States

Apply Now
R&D Engineer

The incumbent will be responsible for developing and performing methods to characterize devices and/or delivery methods. The successful candidate will also assist in the development and characterization of biomaterial-based tissue scaffolds. This role will require daily interaction with stake holders in engineering, biology, in vivo, regulatory, and clinical teams. Presentation of written and oral summaries of progress in team meetings as well as to management is expected. This employee will operate a diverse array of development, manufacturing, and analytical equipment and maintain a safe laboratory environment.

Responsibilities:

· Evaluate user requirements for surgical delivery devices and develop instruments to fulfill those requirements

· Develop testing methods to ensure that user requirements are fulfilled

· Develop method of manufacture, packaging, sterilization, and validation of device in partnership with internal team and external vendors in accordance with current regulations

· Help identify external vendors for all processes needed to provide devices to clinicians

· Complete the design control process for a variety of programs

· Maintain documentation and write reports to support IP, design control, and regulatory filings

· Maintain close communication with surgical, engineering, and project management teams to ensure timely completion of milestones

Requirements/experience with:

· Degree in mechanical or biomedical engineering
- Ph.D. with 4+ years of industry experience
- M.S. with 6+ years of industry experience
- B.S. with 8+ years of industry experience
· Leadership of medical device design and participation in regulatory approval documentation preparation

· Preparation of design control documentation, leading design reviews

· Familiarity with various implantable biomaterials, and their properties and characterization

· Experience with medical device manufacturing processes

· Packaging design and testing

· Sterilization methods and validations

· Outstanding interpersonal skills and established collaborative working habits

· Excellent oral and written communication skills

· Must be available to start work in the immediate future

· Must have authorization to work in the United States
Apply Now
The successful candidate will be a seasoned administrative professional, ideally with experience in a rapidly growing start-up environment preferably, in a biotechnology company.

Responsibilities
- Support Chief Financial Officer and another c level suite member
- Assist the Leadership of a new division within Sigilon with scheduling and logistics of internal and external meetings and events including agenda preparation, travel and other logistics planning, and Sigilon executive internal and external communications
- Build effective relationships with counter-parts in Sigilon existing and potential partner organizations to enable effective prioritization and scheduling of multiple meetings
- Collect and manage important physical and digital division documents, both internal and external.
- Ability to organize a daily workload by priorities and be proactive in attending to those priorities
- Manage and update important informational documents with external parties
- Provide high quality support to assigned members, anticipate needs and foster positive culture
- Uphold a strict level of confidentiality
- Various other duties and tasks as needed
Qualifications
- 5+ years of experience as a Sr. Admin or EA supporting a number of senior level leaders
- Bachelor’s Degree or equivalent required
- Strong organizational, interpersonal and problem-solving skills
- Ability to be discrete with confidential information
- Ability to communicate clearly, both verbally and in writing
- Technically savvy in use of various communication platforms and apps
- Proficient with Microsoft Office suite
Apply Now
Sigilon Therapeutics is searching for a part-time lab coordinator 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.

Responsibilities:
- Maintain and organize stocks of reagents and supplies for laboratory
- Administer lab inventory and ordering systems
- Prepare solutions, reagents and complex media formulations with documentation in a well-maintained laboratory notebook
- Assist scientists with experiments
- Comply with standard laboratory practices and company policies
Requirements:
- Associate degree or enrolled in/completed B.A/B.S. program in the biological sciences
- Comfortable performing basic math calculations
- Read and follow standard operating procedures (SOPs) accurately
- Experience with aseptic technique a plus
- Biology or chemistry laboratory experience in industry or academia a plus
- Communicate well with others
- Detail oriented and well organized
- Skills in MS Office: Word, PowerPoint, Excel, Outlook
- Ability to work and succeed within a matrixed organization
- Self-motivated, responsible and eager to take advantage of an opportunity at a fast growing company
- Flexible but regular schedule with 20-30 hrs weekly
Apply Now
As our lead programs advance into clinical development in 2019, Sigilon is looking for experienced process development scientists 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.

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
Requirements
- BS in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline
- 2 years biologics manufacturing & process development experience required
- Cell therapy specific experience preferred
- Hands-on experience with process development including use of
  bioreactors and use of statistical design of experiments is required
- 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
- Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
Apply Now
The Head of Regulatory Affairs will be the senior regulatory strategist supporting Sigilon’s assets entry into clinical trials by leading, developing and implement regulatory plans to meet company goals and objectives. This is an exciting opportunity to step into a newly created role reporting directly into Sigilon’s Chief Medical Officer.

Responsibilities
- Create and oversee the Regulatory function at Sigilon, identifying, selecting and managing external vendors/consultants and identifying critical internal hires needs
- Supervise team members and external vendors to the Regulatory Affairs function and provide management and guidance across the function
- Formulate and oversee the implementation of regulatory strategy, working in a cross-functional manner with internal functions and external vendors, in alignment with the overall clinical development plan
- Effectively communicate and manage program team and external vendors to meet the designated timelines for deliverables
- Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks
- Be accountable for the development and submission of regulatory documents (e.g., pre-IND and end-of-phase briefing books, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory queries, IND safety reports, etc.)
- Foster strong relationships with FDA, EMA and international regulatory agencies by leading and facilitating meetings, and preparing internal teams and external vendors for these interactions
Requirements
- Bachelor’s degree in life sciences, with an advanced technical degree of MSc or PhD preferred
- 10+ years of experience in regulatory affairs in the biotechnology or pharmaceutical industry, preferably with gene and/or cell therapies or biologics background
- Successful submission, approval, and/or post-approval management of a BLA or NDA/MAA/NDS in multiple ICH regions
- Full functional knowledge of regulatory requirements (Directives, Regulations, and Guidances) pertaining to the development and registration of drug products in multiple ICH regions
- Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills
Apply Now
The ideal candidate will transition easily into the tissue culture of primary cells and cell lines as well as the stable transfection and selection of engineered cell lines and more.

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
- Sc. or M.Sc. degree with a focus on molecular and cellular biology
- 2+ 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
Apply Now