Vertex Pharmaceuticals · 21 hours ago
Director, Downstream Process Development - Biologics
Boston, MA
Full-time
Onsite
Director/Executive
$196K/yr - $293K/yr
11+ years expVertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation. They are seeking a highly skilled technical leader to join their Process Development / Engineering team to lead the design, development, optimization, and scale-up of downstream processes to produce therapeutic biologics.
BiotechnologyHealth CareMedicalPharmaceutical
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)
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 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
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
Preferred
Familiarity with continuous purification technologies and single-use systems is strongly preferred
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 Pharmaceuticals
Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases.
5001-10000 employees
H1B Sponsorship
Vertex Pharmaceuticals 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 (188)
2024 (150)
2023 (111)
2022 (164)
2021 (112)
2020 (80)
Funding
Current Stage
Public CompanyTotal Funding
$657.31MKey Investors
Janssen Belgium
2024-07-10Post Ipo Secondary· $1.11M
2022-05-17Post Ipo Equity· $50M
2009-12-03Post Ipo Equity· $443M
Leadership Team
Reshma Kewalramani
CEO and President
Nina Devlin
Senior Vice President, Chief Communications Officer
Recent News
2026-01-05
2026-01-05
Company data provided by crunchbase