At Synlogic: We are Putting LIFE Into Medicines

We are pioneers in the development of Synthetic BioticTM medicines, a novel class of LIVING medicines intended to transform the lives of patients with a broad range of diseases ranging from genetic and acquired metabolic diseases to inflammation and cancer.

Every day our teams work tirelessly to drive to deliver on 4 aspirations:

• People: LIVING each day with passion for building up and building out our Synlogic team
• Platform: Expanding and enhancing the technology to generate and protect novel LIVING medicines with new and versatile mechanisms of action
• Products: Rapidly developing and commercializing Synthetic Biotics that transform the LIVES of patients and their families
• Promise: Building our company to launch multiple novel LIVING medicines stering a new frontier in medicine

We combine Human Logic and Science Logic to drive meaningful work, careers, and LIFE at Synlogic. We foster a people-focused environment grounded in: Compassion, Transparency, Collaboration & Fun, while adopting a patient-focused mindset to inspire: Innovation, Integrity, High Performance, and LIFE Changing Results.

We continue to build and enhance our organization. If you want a settled environment, pursuing a well-walked path then this environment is probably not for you. If you want to join a growing company, work hard, and challenge yourself to find solutions at a new frontier of medicines then we would love to hear from you.

POSITION SUMMARY:

The Head of GMP Manufacturing will provide strategic leadership for the manufacturing of all live biotherapeutic products at Synlogic. Reporting to the Senior Vice President of Development and Manufacturing, the candidate will be part of a dynamic and motivated team to bring Synlogicovel Synthetic Bioticdicines to clinical trials and eventual commercialization. The VP of Manufacturing will develop a CMO contracting and partnership strategy to support a growing portfolio of clinical products while developing a strategy for life cycle management in manufacturing. This role will interface extensively with the Development, Quality, Regulatory and Program Management functions. The ideal candidate will have proven experience developing and leading a world class manufacturing organization.

KEY ACCOUNTABILITIES/DUTIES:

• Develop a broad, flexible and strategic plan for the manufacturing of Synlogicovel Synthetic Bioticug substance and drug product to support a growing portfolio of clinical programs while planning for accelerated late-phase clinical trials and commercialization.

• Develop production plans and cost models, elucidate product cost drivers and determine the overall cost of goods, while managing risk to enable clinical and commercial manufacturing.
• Establish quantitative manufacturing metrics for Synlogicirst-in-class Synthetic Bioticsli>
• Provide strategic and tactical direction to all manufacturing related operations while building an in-depth understanding of process, formulation and analytical development.
• Develop external relationships with CMOs, partners and contract testing labs.
• Build strong cross-functional relationships with the Quality, Clinical and Regulatory functions to accelerate Synlogic products toward commercialization.

• Lead the generation of manufacturing sections of regulatory submissions, participate in their review and approval, and contribute in the development of strategies to comply with US and international regulatory standards.
• Establish and foster a culture of scientific excellence for the manufacturing organization.
• Advance scientific and regulatory approaches for LBPs via active participation and leadership internally and across industry trade groups and conferences to identify future developments in the live biotherapeutic product space.

Requirements

Required Qualifications & Experiences: The following qualifications and experiences are required for the position:

• B.S., M.S. or Ph.D. in Microbiology, Biochemistry, Chemical Engineering or related discipline with at least 10 years-experience in a manufacturing leadership position.
• Demonstrated experience manufacturing commercial-scale biological products with post-marketing support.
• Demonstrated experience developing manufacturing strategies for clinical and commercial biological products that mitigate risk, manage cost and ensure product availability over the life cycle of the product.

• In-depth experience with selecting and managing CMOs for both drug substance and drug product with demonstrated ability to successfully transfer processes for new clinical drugs to CMOs as well as managing manufacturing of a commercial biological product.
• Broad knowledge of the biopharmaceutical industry, including in-depth knowledge of the processes and functions involved in biologics drug development and life cycle management.
• Demonstrated depth of knowledge of GMP compliance and quality
• Experience managing within a streamlined matrixed organization
• Experience with regulatory submission writing and interfacing with US and ex-US regulatory agencies
• A proven track record in leading scientific teams, including direct people management, preferably with experience managing programs in multiple geographical areas.

Preferred Qualifications & Experiences: The following qualifications and experiences are preferred:

• Experience with GMP manufacturing bacterial or live biotherapeutic products.
• Experience with processes used for the manufacture of solid dose drug substance and drug products.
• Understanding of microbial genetics and biology is highly beneficial.

OTHER REQUIREMENTS:

• Travel to CMOs is expected

BEHAVIORS:

We are at our best when we combine Human Logic and Science Logic to build great teams and deliver outstanding results. Our 6 values of Compassion, Fun, Trust & Respect, Innovation, Integrity and Results are central to our organization.

Our compassion for patients is the engine that drives our innovation and motivates our sense of urgency; always remembering that patients are waiting. Our compassion for each other creates a safe environment for continuous risk taking and personal development. We connect with our colleagues by having fun together. We take our work seriously and value integrity in producing the highest quality work. We trust each other, respecting all ideas and driving accountability to generate the best results for our patients and team. We encourage openness, direct feedback and transparency in decision-making to enable trust and maintain the nimbleness of the group.

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