Selecta Biosciences is seeking a highly skilled, collaborative, and motivated candidate to lead our Analytical Development Team! This position will be part of our team that is developing our nano-particle ImmTOR technology platform, gene therapy candidates, and protein therapeutics that are in pre-clinical, early and late stage clinical development.
The Analytical Development Team is responsible for developing robust, phase appropriate analytical methods for identifying critical quality attributes and implementing phase appropriate control strategies in support of our pre-clinical and clinical development programs. The Director/Senior Director will play a critical and highly visible role within the company by leading the overall strategy and focus for our analytical team.
- Responsible for developing and executing the group’s technical strategy in the context of CMC
- Manage, coach and mentor a highly functional and talented team. Recruit new team members as we expand our organization.
- Manage group activities including timelines, budget, and goals in a growing analytical development group.
- Lead the development of phase appropriate analytical methods and control strategies for our biologic, small molecule and polymer based nano-particle technologies.
- Responsible for the group’s scientific and technical standards, the setting and completion of technical, organizational and individual goals in support of discovery and product development and the critical review of documentation and reports.
- Direct all analytical CMC activities for both drug substance and drug product. Solve complex chemical problems and provide innovative analytical development to the team and company
- Ensure the group’s transparent and reliable interactions with other groups including Translational Biology and Bioanalytics, and Analytical Testing and QC, as well as other functional areas such as Formulation, Process Development, Manufacturing and Biology
- Represent the Analytical Development department and act as analytical expert in cross-functional teams to support product development, core research and development studies.
- Author and review CMC sections of regulatory filings.
- Interact with CROs, including guiding assay development, transfer and method validation.
Educational and/or Experience
A Ph.D. in Chemistry, Biochemistry or related discipline with a minimum of 10+ years of relevant biotech/pharmaceutical industry experience is required. Demonstrated leadership experience and subject matter expertise in biologics and small molecule analytical development in a corporate drug development organization.
Experience in a variety of analytical techniques to support the broad range of therapeutic modalities we are pursuing including small molecule, biologic, gene therapy and nano-particle based drugs.
Excellent critical thinking and strong technical development skills. Understanding of compendial methods, non-compendial test methods for batch release, product characterization, and control of impurities. Experience with characterization methods for product structure elucidation.
Demonstrated leadership in performance management and operational excellence. Proven experience in building a high performing team. Ability to recruit and develop top talent, motivate and empower a team, work cross-functionally, and delegate effectively.
Excellent verbal and written communication directed to all organizational levels including internal working teams, senior management and external partners and suppliers.
Experience in CMC regulatory requirements and authoring CMC sections in support of INDs, BLAs.
Proficiency in a fast-paced environment preferred, with the ability to successfully navigate through ambiguity and a wide variety of technologies associated with the various therapeutic modalities we are pursuing.
The position requires hands-on work setting up and operating equipment in an R&D laboratory. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Company policies, rules, and regulations is required.
While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses.
With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. The company’s first program aimed at addressing immunogenicity to AAV gene therapies is expected to enter clinical trials in early 2021 in partnership with AskBio for the treatment of methylmalonic acidemia (MMA), a rare metabolic disorder. A wholly-owned program focused on addressing IgA nephropathy driven by ImmTOR and a therapeutic enzyme is also in development among additional product candidates. Selecta recently licensed its Phase 3 clinical product candidate, SEL-212, in chronic refractory gout to Sobi. For more information, please visit www.selectabio.com.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).
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