Process Development, Associate Director - Cell Line Development (CLD), Biologics

Vertex Inc.•Boston, MA

49d•Onsite

About The Position

General Summary: Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead and manage activities related to cell line development (CLD) for the production of monoclonal antibodies and other therapeutic biologics, with a strong focus on overseeing programs conducted at external CDMOs. This 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 bring deep technical knowledge in cell line development and act as the technical lead for CLD work. 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.

Requirements

PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience.
Minimum of 8 years of experience in drug substance development and manufacturing.
MS with 12+ years of relevant experience may be considered.
Demonstrated expertise in cell line development for therapeutic proteins including antibodies, ADCs, and fusion proteins.
Strong understanding of molecular biology techniques, vector construction, clone selection strategies, and cell line characterization methods.
Familiarity with industry-leading expression platforms (e.g., GS, CHOZN, CHEF1, etc.) is strongly preferred.
Knowledge of upstream process development and analytical methods related to CLD.
Hands-on experience managing external CDMOs and navigating cross-functional and cross-organizational workflows.
Experience in authoring and reviewing relevant CMC sections of regulatory filings (IND, BLA, etc.).
Proven track record of delivering on complex biologics development programs.
Excellent interpersonal, communication, and organizational skills.
Ability to work independently, manage multiple projects simultaneously, and operate in a fast-paced environment.

Responsibilities

Lead phase-appropriate strategies to develop, select, and characterize stable, high-producing cell lines for monoclonal antibodies, ADCs and other biologics modalities.
Evaluate, select and manage external capabilities for cell line development.
Oversee and review all aspects of the CLD process, including vector design, transfection, clone screening, characterization and cell line stability studies.
Ensure regulatory-compliant cell line development workflows, including clonality documentation and cell bank generation.
Develop and manage project timelines and budget for CLD activites.
Ensure project deliverables, quality standards, and timelines are met in alignment with internal program goals.
Collaborate with internal cross-functional teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs to ensure alignment and knowledge transfer.
Review and approve technical protocols, development reports, and data packages provided by CDMOs.
Provide scientific and strategic input into cell line platform development, technology evaluation, and implementation of innovation from external partners.
Support regulatory submissions (IND/IMPD/BLA) by contributing to or authoring relevant sections and responding to agency queries related to CLD.
Serve as a subject matter expert in regulatory agency interactions, audits, and inspections.