Director, Drug Product 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 development and manufacturing of biologics drug products for our growing pipeline. 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 and manufacturing of biologics drug products. The responsibilities include formulation development primary container development fill-finish process development 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 device development and supply chain management in CMC teams to drive technical and strategic decision-making.

Key Duties and Responsibilities:

• Lead phase-appropriate strategies for drug product development process transfer scale-up and process characterization to support commercial readiness.
• Set-up and oversee external capabilities for developability assessment and formulation screening for high concentration biologics ADCs and other biologics modalities.
• Define and develop robust fill-finish manufacturing processes for liquid and lyophilized drug products in vials pre-filled syringes and other novel primary packaging.
• Oversee drug product technology transfer process development and GMP manufacturing operations at CDMOs.
• Define and develop clinical dose preparation and administration strategies for drug products for multiple indications. Collaborate with clinical and supply chain teams to prepare clinical study documentation.
• Collaborate with the device development team to develop combination product presentations such as pre-filled syringes autoinjectors and advance delivery technologies.
• Define and implement drug substance and drug product stability and shelf-life assessment approaches.
• Develop and manage project timelines resource allocation and budget for drug product programs.
• 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 and best practices to improve process robustness efficiency and compliance.
• Potential in the future to build and manage a team of scientists and engineers to deliver high-quality scalable and compliant drug product 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 product development and manufacturing. MS with 14 years of relevant experience may be considered.

Required Experience and Skills:

• Expertise in formulation development of recombinant proteins including antibodies ADCs and fusion proteins.
• Expertise in developing stable high concentration liquid formulation and dosage forms for biologics and applying cutting-edge technologies to develop stable drug products.
• Deep knowledge in developing aseptic fill-finish manufacturing process for biologics drug products in vials pre-filled syringe and cartridge presentation.
• Experience successfully delivering development programs with CDMOs.
• Proven track record of advancing drug products 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.

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.

#LI-Onsite

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