Director, Downstream Process Development - Biologics
Ver-Tex, Boston, MA, United States
Biologics, Cell and Gene Therapy Technical Leader
Vertex Pharmaceuticals is seeking a highly skilled technical leader to join our Process Development / Engineering team at our new R&D site in Boston Seaport. This leadership role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The responsibilities include purification development, viral clearance, scale-up, 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, external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making. 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 substance development and manufacturing. MS with 14+ years of relevant experience may be considered. Required Experience and Skills: Demonstrated leadership in downstream process development for recombinant proteins including antibodies, ADCs, and fusion proteins. Hands-on experience with chromatography systems, UF/DF systems, and viral clearance strategies. Familiarity with continuous purification technologies and single-use systems is strongly preferred. 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, with the ability to influence and drive decision making at multiple levels within a CMC organization. Demonstrated leadership with experience managing technical staff and cross-functional collaborations. Pay Range: $200,000 - $300,000 Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Company Information: Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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.
Vertex Pharmaceuticals is seeking a highly skilled technical leader to join our Process Development / Engineering team at our new R&D site in Boston Seaport. This leadership role is critical in advancing our pipeline of innovative biologics from early development through to commercial readiness. The responsibilities include purification development, viral clearance, scale-up, 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, external manufacturing and supply chain management in CMC teams to drive technical and strategic decision-making. 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 substance development and manufacturing. MS with 14+ years of relevant experience may be considered. Required Experience and Skills: Demonstrated leadership in downstream process development for recombinant proteins including antibodies, ADCs, and fusion proteins. Hands-on experience with chromatography systems, UF/DF systems, and viral clearance strategies. Familiarity with continuous purification technologies and single-use systems is strongly preferred. 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, with the ability to influence and drive decision making at multiple levels within a CMC organization. Demonstrated leadership with experience managing technical staff and cross-functional collaborations. Pay Range: $200,000 - $300,000 Flex Designation: On-Site Designated Flex Eligibility Status: In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility. Company Information: Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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.