Company Overview

Our mission at Sigilon Therapeutics is to develop improved treatments for chronic diseases using a novel type of therapeutic: implanted cells shielded by proprietary biomaterials from immune attack and the foreign body response (fibrosis). Treatments based on the Sigilon Therapeutics technology platform will act as responsive “living therapeutics” that can provide more natural control for diseases currently treated with intermittent injection or infusion. The company is based in Cambridge, MA. Further information can be found at www.sigilon.com

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%

Company Overview

Our mission at Sigilon Therapeutics is to develop improved treatments for chronic diseases using a novel type of therapeutic: implanted cells shielded by proprietary biomaterials from immune attack and the foreign body response (fibrosis). Treatments based on the Sigilon Therapeutics technology platform will act as responsive “living therapeutics” that can provide more natural control for diseases currently treated with intermittent injection or infusion. The company is based in Cambridge, MA. Further information can be found at www.sigilon.com.

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.

Company Overview

Our mission at Sigilon Therapeutics is to develop improved treatments for chronic diseases using a novel type of therapeutic: implanted cells shielded by proprietary biomaterials from immune attack and the foreign body response (fibrosis). Treatments based on the Sigilon Therapeutics technology platform will act as responsive “living therapeutics” that can provide more natural control for diseases currently treated with intermittent injection or infusion. The company is based in Cambridge, MA. Further information can be found at www.sigilon.com.

Assistant/Associate Scientist is a critical role responsible for coordinating and executing in vivo studies across our R&D organization. Also, this teammate will have the opportunity to be cross-trained in all functions to participate in any experiment as needed. This role will require daily interaction with stakeholders in engineering, biology, in vivo, analytical, and operations teams. Presentation of written and oral summaries of progress in team meetings, as well as to management is expected.

Responsibilities:  

Planning and executing studies – work with the In vivo team to perform rodent studies for the advancement of our pipeline. Activities include dosing, surgical procedures and sample collection.

Experiment scheduling – coordinate between therapeutic leads, cell expansion team, encapsulation, in vivo, assays, and others. Put together a schedule every week and share it with the team. Update daily as needed. Assign responsibility for activities within groups.

Experiment prioritization – work with functional leads to prioritize planned studies to meet company goals and objectives. 

Experiment tracking – daily check-ins on experiments. Coordinate sample handoffs between encapsulation, in vivo, assay, etc. 

Participate in transition to new electronic laboratory system and contribute to data analysis.

Drive continuous improvement against key indicators to improve overall efficiency and throughput. Lead capacity planning by defining theoretical max, identifying bottlenecks, and projecting throughput need based on pipeline goals/needs. 

Automate scheduling processes to improve efficiency and reduce errors by streamlining information transfer between groups and from study templates to schedule. 

Data flow – work across teams to ensure groups share and receive data from completed experiments to enable efficient decision-making. 

Documentation – work with quality to support streamlining paperwork. 

Ensure tech files and writing tasks for studies are completed on time.

Cross-train in all functions for preclinical development to participate in experiments.

Qualification: 

Degree in biomedical engineering, biological sciences, molecular biology, animal sciences, or similar discipline 

0-2+ years of industry experience

Prior experience with animal research and techniques

Outstanding interpersonal skills and established collaborative work habits

Excellent oral and written communication skills

Must be available to start work in the immediate future

Must have the authorization to work in the United States

Our mission at Sigilon Therapeutics is to develop improved treatments for chronic diseases using a novel type of therapeutic: implanted cells shielded by proprietary biomaterials from immune attack and the foreign body response (fibrosis). Treatments based on the Sigilon Therapeutics technology platform will act as responsive “living therapeutics” that can provide more natural control for diseases currently treated with intermittent injection or infusion. The company is based in Cambridge, MA and is funded by Flagship Pioneering. Further information can be found at www.sigilon.com.

The employee 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:

• Tissue culture of primary cells and cell lines

• Participate in the scale-up up of cell production from culture flasks to bioreactors, evaluating equipment and protocols for cell processing equipment

• Work in a matrixed environment to ensure 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

• Perform functional and viability cell-based assays

• 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

• Participate in the coordination of assigned research with other teams as necessary to ensure the completion of the team’s research projects

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

• Comply with standard laboratory practices and company policies

Requirements:

• B.Sc. or M.Sc. degree with a focus on biology or biomedical engineering

• 1+ 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