Company Overview

Sigilon Therapeutics seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform. Sigilon’s product candidates are non-viral engineered cell-based therapies designed to produce the crucial proteins, enzymes or factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases, and diabetes. The engineered cells are protected by Sigilon’s Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.

Sigilon Therapeutics is seeking an experienced and energetic individual to lead all aspects of the execution and management of medical communications activities in rare diseases. The successful candidate must have excellent communication skills and the ability to work independently in a highly interactive and fast-paced environment.

Responsibilities:

• Publication planning, management, and execution:
  • Work with cross-functional team consisting of scientists, legal IP and project leaders to develop publication plan (congress submissions and manuscripts)
  • Provide medical writing support for all publications and work with internal authors to ensure Good Publication Practice and compliance with company SOPs
  • Manage the document review platform (PleaseReview)
• Congress planning and presence:
  • Work with cross-functional team to develop congress plan (sponsorships and booths)
  • Manage all booth applications, planning and staffing
  • Collaborate with Patient Advocacy on shared booths
• Expert advisory boards:
  • Provide support for content development for advisory boards
• Other:
  • Provide scientific review for patient advocacy materials
  • Provide scientific support to other functions as needed (e.g. literature searches, development of materials on specific scientific topics)
  • Manage the scientific literature platform (ReadCube/Papers)
  • Manage the Medical Affairs SharePoint site
• Ability to travel (~ 20%) post COVID

Requirement/Qualifications:

• Advanced degree in life sciences (PhD, PharmD, MD)
• At least three years of experience in medical communications in biotech/pharma setting
• Proven knowledge of Good Publication Practice and Medical Communications compliance landscape
• Ability to quickly collect and synthesize data into reports
• Comfort with management of multiple document platforms
• Experience in gene and cell therapy product and/or rare disease is desirable
• Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
• Proven ability to work independently, take initiative, and effectively handle multiple priorities
• Excellent interpersonal/team skills, strong organizational skills

Sigilon Therapeutics is searching for an energized and highly motivated candidate Assistant/Associate Scientist to be part of a team focused on developing a novel therapeutic product for diabetes utilizing Sigilon’s Afibromer™ technology combined with leading-edge pancreatic islet cell technology. The candidate should have experience with tissue culture of cell lines and with cell and molecular biology assays.

Responsibilities:

• Tissue culture of cell lines and pluripotent stem cell lines
• Establishing protocols and SOPs
• Perform cell-based and molecular biology assays, including cell viability, immunohistochemistry, flow cytometry, qPCR, and functional assays
• Demonstrate understanding and application of relevant scientific literature to the design of experimental protocols
• Make observations, evaluate data, interpret results, and document in a well-maintained laboratory notebook
• Present results of experiments and findings in multidisciplinary team meetings
• 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

Qualification:

• BSc. or M.Sc. degree with a focus on biology, molecular biology or cell biology
• Two years of laboratory experience in industry or academia is desirable
• Experience in tissue culture and cell-based and molecular biology assays, e.g. qPCR, immunohistochemistry, 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

Company Overview

Sigilon Therapeutics seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform. Sigilon’s product candidates are non-viral engineered cell-based therapies designed to produce the crucial proteins, enzymes or factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases, and diabetes. The engineered cells are protected by Sigilon’s Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.

The Director of Supply Operations is responsible for ensuring successful supply planning, labeling, and logistics activities related to clinical, launch, and commercial supplies within the Supply Chain organization. Manages team responsible for overseeing the day-to-day patient supply activities for Sigilon clinical trials and commercial supply, including demand forecasting and distribution of final products. Oversees and reviews demand forecasts and supply plans for accuracy to ensure continuous supply while minimizing risk. Ensures successful distribution of final products to clinical sites, hospitals, and distributors. Works within the Supply Chain organization and cross-functionally with peers to establish and maintain consistent practices that enable a robust and efficient supply chain. Has a working knowledge of supply chain best practices and experience overseeing manufacturing within a cGMP manufacturing environment. Excellent communication skills and ability to work in a highly interactive and matrixed environment. Presentation of written and oral summaries of progress in team meetings as well as to management is expected. Mentors and coaches direct reports.

Responsibilities:

• Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.
• Lead team to ensure successful execution by the team on day-to-day activities
• Develop planning methodology and inventory policy for critical materials, ensuring material supply meets production plans for existing and envisioned projects, with input from Technical Operations functions and other stakeholders
• Oversee patient demand forecasting and review supply plans of clinical products for accuracy

• For late-stage products, work with the Commercial organization to establish launch requirements as well as Commercial demand and implement and lead the S&OP process.
• Support COGS modeling process for Technical Operations
• Lead buildout of Supply Chain processes to enable commercialization (e.g., S&OP, serialization, labeling, shipper qualification, etc.)

• Provide a point of escalation for global logistics network, including 3PLs, Courier, and customs clearance
• Ensure product labels are in compliance with regulations

• Manage budget and track ongoing spending for responsible activities
• Oversee the investigation of exceptions and determine root causes, implement CAPAs and drive to closure. Follow-up of change control to ensure timely implementation in line with regulatory and stock management constraints
• 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
• Oversee the creation and maintenance of Standard Operating Procedures
• Additional responsibilities as required

Requirements:

• Strategic leader and contributor with a proven track record of success.
• Master’s degree in relevant Life Sciences, Supply Chain, or Engineering, or related field is required with 12-15 years of biotech/pharmaceutical Supply Chain experience. MBA preferred.
• Certification in Project Management (e.g., PMI certification) and process improvement methodologies (e.g., Six Sigma) is a plus.
• Strong leadership, mentoring skills, and experience with direct & matrix management.
• Demonstrates a solid understanding of the Supply Chain. Understands interdependencies of parts of the supply chain and stakeholders. Uses industry knowledge to drive best practices within the 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 deviation investigation and CAPA implementation
• Possess strong attention to detail and have exceptional interpersonal, organizational, and communication skills
• An energetic self-starter who is adept at multi-tasking, has a track record of productivity, and capable of working both independently and as part of multiple collaborative teams
• Strong collaboration and excellent team skills to be successful in a cross-functional environment
• Ability to prioritize responsibilities to meet project deadlines and flexibility to react quickly to changing research needs

• Travel up to 20%

Sigilon Therapeutics seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform. Sigilon’s product candidates are non-viral engineered cell-based therapies designed to produce the crucial proteins, enzymes or factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases, and diabetes. The engineered cells are protected by Sigilon’s Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.

Sigilon is seeking an Associate Director to provide strategic and technical leadership for our Bioassay group. The individual, reporting to the Head of Bioanalytical and CMC Analytical Development, will lead a team of experienced scientists to implement bioanalytical strategies, develop fit-for-purpose assays in house, and oversee the assay transfer, validation, and sample tests in CRO partners to support a wide range of cell therapy programs in Sigilon. In addition, he/she will support the potency and other bioassays for CMC product release. The successful candidate will collaborate with other functions (nonclinical development, clinical operation, regulatory and quality, process development, etc) and contribute to a variety of bioanalytical activities in a highly collaborative environment.

Responsibilities:

•Lead and grow a highly productive team and manage daily operation of the bioassay lab.

•Implementing bioanalytical strategy and a wide range of ligand-binding, immunogenicity, and enzyme potency assays in house and in CRO/CMOs to support process improvement, product release, discovery, nonclinical and clinical studies.

•Ensure the data generated internally and externally are in line with study design, scientific vigor, regulatory expectation, and industry’s best practices.

•Represent line function on multidisciplinary teams. Collaborate with other stakeholders on the study protocol and develop aligned bioanalytical plan to ensure timely delivery of the decision-making data.

•Provide oversight of CROs (managing timeline, troubleshooting assays, monitoring performance, assessing method deviation, establishing CAPA, reviewing and approving data reports, etc.).

•Write, review and approve bioanalytical protocols, reports, and associated documents.

•Support regulatory submissions (INDs, CTAs, BLAs) by writing and/or reviewing relevant sections. Interact with regulatory agencies and participate in audits/inspections.

•Drive the development of innovative approaches to addressing challenging bioanalytical issues based on emerging scientific insights, new technologies and program needs.

•Willing to take additional responsibilities as assigned.

Qualifications:

•Ph.D. degree in biochemistry or other biology disciplines with 6+ years of relevant industry experience or BS/MS degree with 10+ years of experience, preferably in cell or gene therapy.

•Ability to persuade peers and inspire junior scientists to meet organizational goals in a fast-paced team-oriented environment.

•Minimum 3 years of experience leading projects and teams as well as developing bioanalytical methods from beginning to end.

•Extensive technical experience in the development and validation of ligand-binding assays and immunogenicity assays supporting toxicology, PK and PD studies.

•In-depth knowledge of GLP/GCP compliance, ICH/FDA guidelines, and industry’s best practices.

•Experience authoring relevant sections of regulatory documents and responding to agency’s inquiries.

•Demonstrated ability to manage regulated (GLP, GCP) bioanalytical studies in CROs to deliver quality results in a stringent timeline.

•Excellent verbal and written communication and collaboration skills.

•Proven record of critical thinking and problem-solving skills.