Process Development, Director Upstream (Biologics)

Job Description

General Summary:

Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead the design development optimization and scale-up of upstream processes to produce therapeutic biologics. This leadership role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The Vertex Process Development team offers a dynamic fast-paced and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best process design scale-up and cutting-edge manufacturing technologies to enable the successful implementation of Biologics Cell and Genetic therapeutics.

The successful candidate will lead the development of upstream process development for biologics such as mAbs ADCs and fusion proteins. The responsibilities include cell line evaluation media/feed strategy optimization bioreactor operations scale-up technology transfer of manufacturing processes to CDMOs and process validation to support our clinical pipeline toward commercialization. This is a highly cross-functional role that will work closely with drug substance development analytical development external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making.

Key Duties and Responsibilities:

• Lead phase-appropriate strategies for upstream process development process transfer scale-up and process characterization to support commercial readiness. This includes cell line evaluation media/feed strategy optimization bioreactor operations and scale-up.
• Set-up and oversee external capabilities for upstream process development of monoclonal antibodies ADCs and other biologics modalities.
• Develop and manage project timelines resource allocation and budget for upstream programs.
• Oversee drug substance technology transfer process development and GMP manufacturing operations at CDMOs in close partnership with downstream development analytical development formulation external manufacturing and quality assurance.
• Manage deviations and OOT/OOS investigations at the CDMOs in collaboration with Quality External Manufacturing and Regulatory team.
• Define and implement control strategies validation protocols and process characterization studies in accordance with Quality by Design (QbD) principles.
• Author and review regulatory submissions: IND/IMPD briefing books and BLA.
• Serve as a subject matter expert in regulatory agency interactions audits and inspections.
• Identify and implement innovative technologies (e.g. perfusion systems single-use bioreactors process intensification) to improve process yields robustness and efficiency.
• Potential in the future to build and manage a team of scientists and engineers to deliver high-quality scalable and compliant upstream drug substance processes from early development through commercialization.
• Expected travel: 10-20% (domestic and international)

Required Education:

• PhD in Chemical Engineering Biochemical Engineering Pharmaceutical Sciences or related discipline with commensurate years of education and experience.
• Minimum of 11 years of experience in drug substance development and manufacturing. MS with 14 years of relevant experience may be considered.

Required Experience and Skills:

• Demonstrated leadership in upstream process development for recombinant proteins including antibodies ADCs and fusion proteins.
• Expertise in mammalian cell culture technologies (CHO cell systems preferred). Experience with continuous bioprocessing or perfusion-based manufacturing is strongly preferred.
• Experience with process scale-up to pilot and/or commercial scale including tech transfer to GMP facilities.
• Hands-on experience with bioreactor systems (e.g. Ambr benchtop pilot and commercial-scale bioreactors).
• Experience successfully delivering development programs with CDMOs.
• Proven track record of advancing drug substance from INDs into late phase development and commercialization.
• Experience with process characterization process control strategy establishment and process performance qualification for commercialization using Quality by Design (QbD) principles.
• Extensive knowledge of cGMPs and regulatory guidelines for biologics and can serve as an internal thought-leader to drive decision making.
• Strong data analysis and scientific communication skills including experience with regulatory documentation with the ability to influence and drive decision making at multiple levels within a CMC organization.
• Demonstrated leadership with experience managing technical staff (internal or external) and cross-functional collaborations.

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at