Sigilon Therapeutics is seeking an Associate Scientist to join the assay group, which develops and performs biological assays for multiple therapeutic programs across the company.

Responsibilities

• Perform standardized protocols for quantifying and assessing the activity of therapeutic proteins, including ELISA, cell-based assays, and biochemical/enzymatic assays.
• Assist with assay development and internal/external assay transfers.
• Analyze, interpret, and present experimental data in multidisciplinary team meetings.
• Coordinate with molecular biology, cell biology, engineering, and in vivo team members to manage assay request queue and ensure timely delivery of assay data.
• Maintain detailed records in electronic laboratory notebook and sample management system.
• Participate in the evaluation and adoption of new technology/equipment to expand the capabilities of the assay group.

Requirements

• BS in biochemistry, cell biology, molecular biology, or related discipline. Masters preferred.
• At least 2 years of experience in the pharmaceutical/biotechnology industry, specifically in performing bioassay protocols.
• Experience with cell and molecular biology techniques, including ELISA/MSD/Gyros, Western blot, mammalian cell culture, and other gene/protein expression assays.
• Experience with plate-based readers and analysis software, such as SoftMax Pro, BioTek Gen5, GraphPad Prism, and Excel.
• Exceptional attention to detail, particularly as it relates to the accuracy and precision of assays.
• Experience with assay qualification and validation in a GLP environment is a plus.
• Ability to work effectively with minimal supervision after initial training.
• Ability to set priorities and multi-task activities to effectively manage workflows and deliverables.
• Strong team orientation, with excellent written and oral communication 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 cell and molecular biology, liquid handling applications or microfluidics, and automation of data analysis.

Responsibilities

· Aseptic tissue culture of cells

· Automation of data analysis to enable high-throughput experimental design

· Establishing protocols and SOPs

· Perform in vitro assays including cell viability, ELISA, immunohistochemistry, and various functional assays

· Demonstrate understanding and application of relevant scientific literature experimental design

· 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 biology, cell/molecular biology, or bioengineering

· Minimum of 2 years laboratory experience in industry or academia desirable

· Experience in cell culture and/or molecular biology assays

· Experience in liquid handling / assay automation or microfluidics

· Knowledge of basic programming languages (e.g. MATLAB, Python, R, etc) desirable

· Outstanding interpersonal skills and established collaborative working habits

· Excellent oral and written communication skills

· Must enjoy coming to work and having fun while creating therapies that improve the lives of patients

Sigilon is seeking an Associate Project Manager/Project Manager to drive the overall success of our R&D programs and platform development. This person will join a highly motivated team in Cambridge, MA, and will work collaboratively with the program teams to plan, track and report the diverse activities of R&D including discovery, preclinical research, project strategy, and budgeting.

Responsibilities

· Lead teams to milestones quickly with precision by defining optimal strategy for advancement of the project

· Ensure teams are constantly focused on “killer” experiments rather than non-value driving experiments

· Define milestones, critical path activities, timeline, risks, assumptions, mitigation plans, and budgets for proposal preparation

· Liaise directly with key stakeholders to understand their needs and constraints

· Manage projects from the proposal stage through commercialization

· Track technical and commercial progress and achievements

· Work on multiple teams at one time

· Setup project management tools and process to drive efficiency in projects

Requirements

· Bachelor degree or an advanced degree within a scientific discipline

· A proven track record in the delivery of multiple large and complex development projects to time and budget within a regulated environment

· Experience managing risk and timeline on development projects with considerable novel content

· Experience managing multidisciplinary teams, often across different client sites and geographies

· Excellent oral & written communication skills

· A self-motivated team player attitude, who is highly proactive, accountable, and enthusiastic about drug discovery and development

· Prefer experience in taking a putative drug from concept through to launch including scale-up and transfer to manufacture

· Prefer experience in biologics or cell derived products

· Prefer experience in metabolic or rare diseases

Sigilon is seeking a Project Manager/ Senior Project Manager to drive the overall success of our R&D programs and platform development. This person will join a highly motivated team in Cambridge, MA, and will work collaboratively with the program teams to plan, track and report the diverse activities of R&D including discovery, preclinical research, project strategy, and budgeting.

Responsibilities

· Lead teams to drive projects to milestones as quickly as feasible

· Insure teams are constantly focused on “killer” experiments rather than non-value driving experiments

· Management of projects from the proposal stage through commercialization

· Liaising directly with stakeholders to understand their needs and constraints

· Estimating timeline, resource, budget and key technical risks for proposal preparation

· Tracking technical and commercial progress and achievements

· Working on multiple teams at one time

· Direct oversight of identifying, assessing, prioritizing external vendors to conduct key components of R&D pipeline projects

Requirements

· M.S./Ph.D. degree within an engineering or scientific discipline

· A proven track record in the delivery of multiple large and complex development projects to time and budget within a regulated environment

· Experience of managing risk and timeline on development projects with considerable novel content

· Experience of managing multidisciplinary teams, often across different client sites and geographies

· Excellent oral & written communication skills

· A self-motivated team player attitude, who is highly enthusiastic about drug discovery and development

· Experience in taking a putative drug from concept through to launch including scale-up and transfer to manufacture

· Prefer experience in biologics or cell derived products

· Prefer experience in metabolic diseases

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%

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

The Director / Sr Director 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
• 5+ 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