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

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

· 2-5 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 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 an experienced process development scientist to be the strategic leader of our process development team. Responsible for technical development and CMC activities that enable programs from preclinical stages through clinical manufacturing, the ideal candidate should also possess the ability to successfully interface with multidisciplinary teams, engage and collaborate with external manufacturing partners. Key objectives are to enhance and evolve the manufacturing process for Sigilon’s encapsulated allogeneic cell therapy platform, to develop robust and scalable cell therapy bioprocesses and transfer these processes to contract manufacturing partners.

Responsibilities:
- Develop and execute a manufacturing process development strategy in collaboration with biology and chemistry development teams with a focus on cell therapy bioprocessing
- Lead a team accountable for delivery against timelines and goals for developing, qualifying and validating processes for clinical product
- Oversee the 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 and Regulatory functions as well as functional leads to maintain alignment of goals and to navigate project obstacles.
- Contribute to authoring and assembling CMC sections of regulatory filing(s) as needed.
- Periodically travel to CMOs, CROs and collaboration partners.
Requirements:
- MS or Ph.D in chemistry, biology, engineering or a related discipline with 10 years biologics and/or cell therapy process development experience
- Significant experience with a variety of mammalian cell culture technologies and operations, cell therapy specific experience preferred, including experience with bioreactors at multiple scales
- 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
- Strong leadership, mentoring skills and experience with direct & matrix management
- Innovative, critical and creative thinker, unafraid to propose aggressive solutions to complex problems
- Ability to communicate and represent group to a variety of stakeholders
Apply Now
The incumbent will be responsible for developing and performing methods to characterize laparoscopic delivery devices and equipment. The successful candidate will also assist in the development of methods to characterize hydrogel-based tissue scaffolds. This role will require daily interaction with stake holders in engineering, biology, and surgery. 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 analytical equipment and maintain a safe laboratory environment.

Responsibilities:
- Evaluate user requirements for a laparoscopic surgery device and develop an instrument to fulfill those requirements
- Develop testing methods to ensure that user requirements are fulfilled.
- Develop method of manufacture, packaging, and sterilization of device in accordance with current regulations
- Guide the design control process
- Train and direct engineering technicians as needed
- 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:
- Degree in mechanical or biomedical engineering or related field (M.S.)
- Minimum of 7 years industry experience
- Proven track record of designing and achieving regulatory approval of laparoscopic and/or arthroscopic instruments
- Familiarity with polymeric biomedical materials and their properties
- Experience with medical device manufacturing processes
- (eg, polymer welding, joining dissimilar materials, injection molding, SLA) and packaging (material selection, seal formation and testing)
- Experience with human factor analysis of surgical devices
- Experience with contemporary computer software: electronic laboratory notebooks, Microsoft Office, CAD or similar 3D modeling software, SciFinder
- Outstanding interpersonal skills and established collaborative working habits
- Excellent oral and written communication skills
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
- 5 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
Sigilon Therapeutics is searching for an energized candidate to manage our external manufacturing supply chain. This role is responsible for planning, forecasting and ensuring supply of clinical drug product as well as managing clinical trial drug product shipments and scheduling. The position will entail building strong cross-functional relationships throughout the organization as well as managing a complex external manufacturing supply chain.

Responsibilities
- Design and manage clinical supply chain, including ordering process, scheduling, shipping, courier management, and CMO coordination, for multiple products and multiple clinical sites globally
- Develops and implements overall strategy for External Manufacturing and Supply, in collaboration with other Technical Operations functions
- Drive large contract development, review and approval with Legal, Finance and Sigilon's leadership team
- Manage external partners and act as key driver of strategic partner management approaches and supplier governance
- Lead the development of external CMC project plans for existing and envisioned projects, with input from other Manufacturing Sciences and R&D functions
- Develop inventory policy ensuring material supply meets production plan needed to meet demand, including complex supply chain of small molecule, polymer and cell therapy manufacturing partners
- Ensure supply of drug product to support clinical trials by aligning internal and external manufacturing production plans and capacity to meet clinical demand
- Build and manage global logistics network, including 3PLs, Courier, US and ex-US shipping lanes, freight forwarding/customs clearance partners for trials
- Coordinate with Clinical Operations to manage drug shipment scheduling to trial sites
- Manage budget and long-range planning
- Establish key performance indicators in alignment with company and Technical Operations goals
- Builds cross-functional relationships with Sigilon team members
Requirements
- BS in chemistry, biology, engineering or a related discipline, MS or Ph.D. is strongly desired.
- Minimum 8 years of experience in manufacturing and/or CMC-supply chain management including CMO partnership management
- The ideal candidate has deep experience in GMP operations, experience with cell therapy or other novel modality supply chain preferred
- Demonstrated success in delivery of a complex therapeutic program into the clinic
- Strong leadership, mentoring skills and experience with direct & matrix management
- Project, program or alliance management strongly desired
Apply Now
Sigilon Therapeutics is searching for an energized candidate to lead a new team focused on CMC and manufacturing a novel therapeutic product for diabetes utilizing Sigilon’s Afibromer™ technology combined with leading edge pancreatic islet cell technology. This individual would have primary responsibility for all aspects of CMC and manufacturing including: process development, analytical development, and CMC. Initial emphasis will be on partnering with the research team to create a protocol that can be transferred to a CMO. Management of the CMO relationship will be a key responsibility. The team will have full access to all of Sigilon’s cell biology and encapsulation chemistry expertise along with substantial designated funds to enable a rapid pursuit of a very robust and competitive program.

Responsibilities
- Accountable for delivery against timelines and goals for a diabetes focused therapy
- Execute the CMC strategy required for delivery of a therapeutic into the clinic
- Build a team to oversee process development, analytical development, and CMC
- Work closely with the Research team to deliver a robust process for tech transfer
- Previous experience solving complex process development challenges
- Experience with tech transfer and CMO management is critical
- Experience navigating CMC elements of a cell therapy focused IND
Requirements
- PhD in chemistry, biology, engineering or a related discipline is strongly desired
- Strong technical CMC expertise is required, although candidates without formal scientific educational background in CMC-related fields may still be considered
- Strong leadership, mentoring skills and experience with direct & matrix management
- Minimum of 10 years experience in manufacturing and/or CMC-product development, experience in cell therapy strongly desired
- Experience across the cell therapy supply chain preferred
- Expertise in stem cell biology and cell-based therapeutics including scale-up work is highly desired
- Experience leading a team of scientists focused on delivery against milestones
- Project, program or alliance management strongly desired
- Demonstrated success in delivery of a complex therapeutic program into the clinic
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
Sigilon Therapeutics seeks a highly motivated, energetic, and results-driven organic chemist to join its chemistry group. The role will consist of laboratory work in support of the chemistry team’s efforts to design, synthesize, and optimize reactions around Sigilon’s proprietary Afibromer® technology. This person will assist in the development of small molecules, polymers, and medical devices with both established and novel techniques. This role will require regular interaction with stake holders in many disciplines and the presentation of written and oral summaries of progress the chemistry group. Sigilon Therapeutics operates with a typical hybrid of internal and external resources and maintains a safe laboratory environment. Experience in polymer synthesis and manipulation is preferred but not required.

Responsibilities
- Perform the synthesis of both routine and novel small molecules, polymers, and macromolecular conjugates
- Troubleshoot synthetic and analytical chemistry issues
- Participate in transfer of technology to regulated contract manufacturing organizations
- Suggest new areas to explore that contribute to company goals
- Coordinate with the analytical, engineering and biology groups within the company
- Maintain a safe laboratory culture
Requirements
- B.S.+10 years/M.S.+10 years/Ph.D.+5 years industrial organic chemical experience
- Experience with synthesis and process optimization of a diverse range of small molecules, polymers/biopolymers, and macromolecular conjugations
- Able to take detailed notes and observations about their experimental design, set-up, results, and analyses and to record those experimental results in both ELN and presentation format
- Skilled operator and interpreter of NMR, LCMS, IR, and UV/Vis spectra
- Experience with contemporary chemical software and reaction platforms: ELNs, SciFinder/SciFinderⁿ, MestreNova, ChemDraw, and Mettler Toledo EasyMax, Syrris Atlas systems
- Familiarity with technology transfers to GMP processes is preferred
- Outstanding interpersonal skills and established collaborative working habits
Apply Now
Sigilon Therapeutics is seeking a Scientist, Biomaterials to join the team!

Responsibilities:
- Design and execute studies furthering the development of a novel biopolymer cell encapsulation system
- Develop assays, including imaging of cells within biomaterial matrices
- Work in a matrixed environment to ensure study plans and biomaterials meet the needs of the in vivo and cell biology teams
- Serve as a mentor in the lab, including managing direct reports, and assisting in study coordination, planning, execution and data interpretation with an energetic team
- Drive the design and prioritization of studies for research and development with key stakeholders across disciplines
- Establish protocols and SOPs for encapsulation and other related activities
- Stay up-to-date on current literature to guide further platform development
- Present results of experiments and findings in multidisciplinary team meetings
- Comply with standard laboratory practices and company policies
Requirements:
- Ph.D. degree with a focus on biomaterials, engineering, biochemistry or biology
- 2 years industry experience preferred
- Experience in biomaterials or tissue engineering is required
- Experience managing direct reports is 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, Inc. is looking to add a part-time AP Clerk to our growing staff. The AP Clerk will report directly to the AP Accountant and will be responsible for general accounting responsibilities among other tasks.

Responsibilities:
- Accurate and timely processing of vendor invoices into the NetSuite system
- Ensuring proper coding and approvals for invoices
- Investigating and following up on invoice and purchase order issues as needed
- Reconciling vendor statements
- Filing invoices and keeping vendor records up to date
- Providing accounting and clerical support to the accounting department
- Assisting with 1099 preparation
- Other ad hoc projects
Requirements:
- Accounting experience (currently pursuing an accounting degree is a plus)
- Experience with accounting software (Netsuite a plus)
- Data entry experience preferred
- Strong working knowledge of Excel and MS Office
- Detail oriented and well organized
- Able to communicate with others
- Ability to meet deadlines and prioritize tasks
- Ability to multi-task and work in a fast paced, start-up
  environment
- Self-motivated and eager to take advantage of an opportunity at a fast growing company with room for growth
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