Director, Downstream Process Development - Biologics

Job Description

General Summary:

Biologics, Cell and Gene Therapy is a rapidly growing part of Vertex Pharmaceuticals where research, development, and clinical manufacturing are highly integrated together at our new R&D site in Boston Seaport.

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 downstream 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 downstream process development for biologics such as mAbs, ADCs and fusion proteins. The responsibilities include purification development (e.g., capture chromatography), polishing steps, viral clearance, 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 downstream process development, process transfer, scale-up and process characterization to support commercial readiness.
• Set-up and oversee external capabilities for downstream process development of monoclonal antibodies, ADCs and other biologics modalities. This includes directing activities such as capture chromatography, polishing steps, and viral clearance.
• Develop and manage project timelines, resource allocation, and budget for downstream programs.
• Oversee drug substance technology transfer, process development and GMP manufacturing operations at CDMOs, in close partnership with upstream 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.
• Develop and implement strategies for improved purification efficiency, robustness, and cost-effectiveness, including evaluation of new technologies and materials.
• Potential in the future to build and manage a team of scientists and engineers to deliver high-quality, scalable, and compliant downstream 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 downstream process development for recombinant proteins including antibodies, ADCs, and fusion proteins.
• Hands-on experience with chromatography systems (AKTA, Unicorn), UF/DF systems, and viral clearance strategies. Familiarity with continuous purification technologies and single-use systems is strongly preferred.
• Experience successfully delivering development programs with CDMOs.
• Strong track record of scaling processes from lab to pilot and GMP/commercial production.
• 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 Vertex’s 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 person's 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 [email protected]