Sr. Engineer/Scientist Gene Therapy Manufacturing
Selecta Biosciences is seeking a talented and highly motivated Sr. Engineer/Scientist to join our fast-paced growing company. Selecta’s Process Development and Manufacturing group is responsible for producing drug product for use in clinical trials and for scaling production of those drugs for the commercial market. The Sr. Engineer/Scientist Gene Therapy Manufacturing requires a high level of technical expertise in the development and production of viral vectors, specifically AAV, including triple transfection and baculovirus technology. The successful candidate will be a subject matter expert for all gene therapy products and responsible for managing contract manufacturers to develop and manufacture clinical trial material.
This position requires a high degree of familiarity with quality and regulatory requirements related to the cGMP manufacture of gene therapy products. This position involves close collaboration with internal and external analytical, quality, and regulatory groups. The candidate must be a strong individual contributor that is able to think critically and work independently, while also contributing effectively within a team environment. Technical leadership skills along with excellent interpersonal and communication skills are required.
This position requires excellent organizational skills and the ability to multi-task in an extremely fast-paced environment with changing priorities. The ideal candidate will have a degree in Biochemical Engineering, Molecular Biology, Virology, Biochemistry, or a related scientific discipline with 7+ years relevant experience.
- Be the primary point of contact with contract development and manufacturing organizations (CDMOs) performing gene therapy process development and manufacturing activities
- Travel to CDMO locations as needed to participate in technology transfer and supervise manufacturing activities
- Maintain expertise in gene therapy-related cell culture, purification, analytical strategies, equipment, and processes
- Ensure robust, scalable, commercially-viable gene therapy manufacturing processes are properly developed
- Ensure sufficient quantities, quality, and timeliness of deliverables
- Manage budgets and schedules to meet project/organizational goals
- Review and approve cGMP-compliant documentation (such as master batch records and SOPs), as well as the post-manufacturing review and close-out of executed batch records
- In conjunction with QA, ensure all CDMOs and processes are compliant with the applicable requirements and regulations
- Author and/or review appropriate sections of regulatory filings and development reports
- Maintain current knowledge of cGMP, industry standards, and best practices
- Present results and project updates to Process Development group and project teams
- Complete high-quality work according to aggressive timelines
- Provide expertise and leadership in the resolution of complex technical or operational problems
- Perform duties according to applicable Company safety procedures
- Perform other duties as necessary
Educational and Experience
- Bachelor’s Degree or higher in Biochemical Engineering, Molecular Biology, Virology, Biochemistry, or related discipline, advanced degree preferred
- 7 or more years of experience in bioprocess development at least 2 years working in the pharmaceutical industry with a strong preference for working with or for outside CDMOs
- Prior cGMP gene therapy manufacturing experience for clinical-stage products is preferred
- Proficient with timeline development and project tracking using MS Project is preferred
- Travel: Up to 25% of the time, including international travel to CDMO facilities
- Title commensurate with experience.
At times, the position may require hands-on work in an R&D laboratory and traveling to CDMOs to work in their clean rooms. While performing the duties of this job, the employee may handle hazardous chemicals in the laboratory.
The Company has active programs on developing novel immunotherapies for various food and environmental allergies. An employee may be required to work with and/or be exposed to allergens in the laboratory.
Qualified candidates should apply online at www.selectabio.com/careers.
About Selecta Biosciences, Inc.
Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP) to a range of biologics for rare and serious diseases that require new treatment options. The company's current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company's lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta's clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).