Head CMC Strategy and Operations

Head of CMC Strategy and Operations

NO PHONE CALLS OR AGENCIES PLEASE.

Selecta Biosciences is seeking a talented, dedicated, and enthusiastic candidate to lead our CMC Strategy and Operations! The position is responsible for providing the overall scientific and operational leadership for Chemistry, Manufacturing and Controls (CMC) functions, including formulation, analytical development, process development and manufacturing, for the early and late stage development of targeted nanoparticle-based immunomodulatory agents according to the strategic needs and objectives of the Company.

Principal Duties/Responsibilities

• Lead and further develop the CMC function at Selecta
• Set strategic direction for formulation, analytical development, process development and manufacturing to achieve company goals and be responsible for its execution
• Lead the CMC team in preparation of sections of regulatory submissions including formulating the strategy as well as overseeing the drafting, review and finalization of documents
• Foster cross-functional thinking and work collaboratively to align the CMC team with the overall company objectives and ensure CMC is aligned and supporting multiple project teams
• Represent CMC functions and be the first-line interface with Clinical, Regulatory, Quality and Program Management functions
• Set CMC strategy, priorities and budget
• Lead and manage a talented group of scientists and engineers
• Manage internal as well as external projects with CROs, CMOs and other vendors including partners in Europe and China
• Ensure entire group works safely and in compliance with Company Environmental, Health and Safety policies

Educational and Experience

• Requires PhD in related scientific discipline, with a minimum of 10 years' related experience or MS with 12+ years' experience in a research environment.
• Experience in authoring and reviewing CMC sections of Regulatory Filings (IND, BLA, NDA) required
• Expert knowledge of scientific principles and concepts required
• Demonstrated knowledge and skill in drug development
• Demonstrated experience in successful management of people and functions
• Excellent verbal, written, interpersonal and presentation skills must be evident
• Ability to work independently required.
• Must have strong organizational, planning and time-management skills.

 The level of this position will be based on the final candidate's qualifications.

 Work Environment

This role will be performed primarily in an office environment, although supervision of work in the lab and, at times. some work in a lab environment may be required and adherence to Company environmental, health and safety policies, rules, and regulations is required.

 About Selecta Biosciences, Inc.

Selecta Biosciences, Inc. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance technology (ImmTOR) platform. Selecta plans to combine ImmTOR with a range of biologic therapies for rare and serious diseases that require new treatment options due to high immunogenicity. The company's current proprietary pipeline includes ImmTOR-powered therapeutic enzyme and gene therapy product candidates. SEL-212, the company's lead product candidate, is being developed to treat chronic refractory gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta's proprietary gene therapy product candidates are in preclinical development for certain rare inborn errors of metabolism and incorporate ImmTOR with the goal of addressing barriers to repeat administration. Selecta is based in Watertown, Massachusetts.

For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter.

NO PHONE CALLS OR AGENCIES PLEASE.

Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).