Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The Opportunity
Manufacturing Sciences supports the production of drug substance, drug product, and complex starting materials such as cell banks and plasmids. The Manager of Manufacturing Sciences will be a key member of the Manufacturing Sciences team, working collaboratively and leading matrix teams to ensure successful technology transfers and manufacturing campaign execution, with focus on Drug Product manufacturing. Additionally, he/she will be responsible for supporting late stage development/commercialization activities inclusive of process validation. The incumbent will be responsible for authoring risk assessments, technical reports, and CMC content for regulatory submissions as required in support of technology transfer or commercialization activities
What You'll Be Doing
- Support the development of technology transfer plans and manage transfer from Process Development and into the selected manufacturing site (internal or external) in partnership with Process Development, Analytical Development, Quality, and the Manufacturing Operations. Lead necessary meeting forums (project team meetings, tech transfer working groups) to manage technology transfer and campaign readiness.
- Conduct process fit assessments to inform manufacturing site selection and define technology transfer scope. Partner with Engineering and Process Development to establish requirements for capital equipment as required.
- Collaborate with process development and other stakeholders as necessary to define the manufacturing process requirements. Author tech transfer deliverables (PFD, BOM, Sample Plan) to articulate the process for transfer.
- Provide technical oversight of manufacturing processes once transferred into manufacturing. Establish and maintain product knowledge expertise, ensuring critical processing knowledge is translated effectively to operational personnel and others as required.
- Lead investigation/resolution of major manufacturing deviations. Support product impact assessment for significant quality investigations. Provide technical assessment of proposed process changes for potential product, supply and/or regulatory impact.
- Author technical protocols, process change controls, technical support memos, tech transfer deliverables, risk assessments and campaign summary reports as relevant to support manufacturing campaigns.
- Support development of the control strategy and process validation master plans. Lead risk assessments/mitigation plans as required to support the establishment of the control strategy. Author required PPQ/CPV protocols/reports and provide technical guidance as required to other protocols.
- Provide technical review of product related regulatory submissions and author CMC content as appropriate.
- Serve as a subject matter expert for partner / regulatory agency inspections.
We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
- BS/BA in either biological or chemical science or engineering or equivalent technical discipline. Master’s in science or engineering is preferred.
- Minimum 8 years BS / 5 years MS industry experience supporting the development or manufacture of viral vectors, biologics, pharmaceutical or vaccine products. Experience supporting products across multiple stages of development desirable.
- Minimum 2 years industry experience transferring or receiving manufacturing drug substance or drug product manufacturing processes. Experience transferring to both internal and third party manufacturers is desirable.
- Demonstrated scientific creativity, technical proficiency and knowledge of scientific concepts. Expertise in Drug Product manufacturing and working knowledge of cell culture/fermentation, purification.
- Good understanding of aseptic manufacturing and associated regulatory requirements
- Proven ability to pragmatically manage complex technical projects and cross-functional teams.
- Strong oral and written communication skills with demonstrated ability to communicate at multiple levels in an organization.
- Proficient in authoring technical documents, reports, protocols, and regulatory submissions including (INDs, BLAs, and equivalent).
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally. Apply for this job
