Vertex · 2 months ago
Director, Drug Product Process Development – Biologics
Boston, MA
Full-time
Onsite
Director/Executive
$196K/yr - $293K/yr
11+ years expVertex Pharmaceuticals is a global biotechnology company focused on scientific innovation. They are seeking a highly skilled Director of Drug Product Process Development for Biologics to lead the development and manufacturing of biologics drug products, ensuring successful implementation of therapeutics through collaboration with cross-functional teams.
Computer Software
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)
Qualification
Required
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
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
Benefits
Medical, dental and vision benefits
Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
Educational assistance programs including student loan repayment
A generous commuting subsidy
Matching charitable donations
401(k)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase