Executive / senior industry position
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Experienced scientist contributing to the development of GMP manufacturing processes for clinical and commercial cell and/or gene therapy products. This position will provide end to end technical support and strategies to our clients in partnership with project management and business development. This role will require very strong verbal and written communication skills to interface effectively with external clients and internal stakeholders across multiple departments to accelerate products to reach the clinic or commercial markets.
- Client-facing technical lead across multiple products/projects responsible for effective communication to clients on technical strategies, business practices, change management policies, and authoring proposals for new scopes of work
- Communicating with clients for technical solutions including estimates for timelines, resource needs, and cost by working with internal stakeholders
- Advises platform process technology development with responsibility for launch activities and facilitating business workflows
- Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments,
- Coordinates function group activates for project technical deliverables, troubleshooting, deviation investigation, and product impact assessment for projects employing developed technology/processes. Serves as an internal subject matter expert (SME).
- Interacts internally with Business Development, Process and Technology Development, Analytical Development, Manufacturing, Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management groups. Interacts externally with clients, material/equipment vendors, and commercial partners.
- 8 - 12 years of relevant experience with a Masters’ degree
- 4 - 8 years of relevant experience with a PhD
- Degrees must be in Chemical Engineering, Virology, Biology, Biochemistry, Immunology, Bioengineering or related fields.
- Process development or GMP manufacturing experience in at least one of the following product types and processes:
- Cell therapy - procedures for the isolation, transduction/activation, expansion and cryopreservation of gene modified patient-derived cells. Familiarity with handling of apheresis materials and / or whole blood and related cell processing equipment
- Gene therapy upstream: mammalian cell culture, adherent culture vessels, closed system technologies, single-use bioreactors, transient transfection, and viral infection
- Gene therapy downstream: purification of viral vectors including lysis, clarification, TFF, nuclease treatment, chromatography, centrifugation, and/or sterile filtration
- Formulation and filling: technologies for cell and gene therapy products including drug product bags and vials, manual filling techniques, automated filling technologies, filling qualification and validation protocols, and clinical regulatory guidelines
- Experience leading technology transfers for GMP manufacturing processes
- Very strong written communication skills including technical writing experience with technical memos, protocols, reports, regulatory filings, and/or business proposals
- Leadership skills such as cross-functional influence and communication, effective escalation, and strategic decision-making capability
Preferred Knowledge / Skills / Abilities:
- Experience with cell and gene therapy products is preferred, but experience with protein or vaccine purification/formulation may also be considered.
- Experience conducting process risk assessments, facility fit assessments, and process qualification/validation requirements
- Experience or exposure to at least one of the following areas in addition to the requirements above: Quality Control, drug product filling, quality assurance, and/or regulatory requirements
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.
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