Vertex · 2 months ago
Process Development, Director - Upstream (Biologics)
Boston, MA
Full-time
Onsite
Director/Executive
$196K/yr - $293K/yr
11+ years expVertex is a global biotechnology company seeking a highly skilled technical leader to join their Process Development / Engineering team as a Director for Upstream processes in Biologics. The role involves leading the design, development, optimization, and scale-up of upstream processes to produce therapeutic biologics, ensuring that innovative biologics advance from early development to commercial readiness.
Computer Software
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)
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 substance development and manufacturing. MS with 14+ years of relevant experience may be considered
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
Preferred
Experience with continuous bioprocessing or perfusion-based manufacturing is strongly preferred
Benefits
Annual bonus
Annual equity awards
Overtime pay
Medical benefits
Dental benefits
Vision benefits
Generous paid time off
Educational assistance programs including student loan repayment
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
Represents job field similar to this job
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