Associate Director, Drug Substance Manufacturing

Our vaccine client here in Boston, MA is growing and looking to add an Associate Director, Drug Substance Manufacturing to support their External Manufacturing team (Hybrid ~ onsite/WFH)! This role will support ongoing vaccine product lifecycle activities for Phase 3 and commercial drug substances and drug products, including tech transfer, PPQ, and commercial support. In addition, role will oversee, develop, and manage external and internal cross-functional activities required to advance company's manufacturing goals. Other responsibilities include but not limited to:

• Author, review and data verification of technical documents, reports, and specifications.

• Review and approval of technical documents from CDMO: SOPs, experimental protocols, batch records, material specifications, validation protocols and reports.

• Systematization of large amount of technical documentation into GMP controlled records and documents.

• Interpretation and communication of technical information and risks internally and externally to facilitate decision making.

• Participation in risk assessments, deviations investigations and change control implementation as a technical assessor.

• Collaboration and communication with cross-functional team, including quality, supply chain, analytical, regulatory teams, on all aspects of product life cycle support.

• Development and implementation of proposals for continuous improvement, including manufacturing process performance and operational procedures.

• Author and manage internal quality documents not limited to Deviations, CAPAs, Change Controls etc.

Requirements:

• PhD with minimum of 8 years' experience or MS with minimum of 10 years' experience or BS with minimum of 12 years' of experience in science or engineering, biopharmaceutical manufacturing.

• External manufacturing experience and effective working relationship with CDMOs preferred.

• Strong technical expertise in vaccines manufacture, recombinant protein production using Insect Cell culture and Baculovirus platform is highly desirable.

• Phase 2 / Phase 3 Technical experience with Drug Substance unit operations of cell culture scale-up, Baculovirus expansion, SU bioreactors and systems, depth filtration and downstream processes highly desirable

• Strong technical writing (authoring, review, revision, data verification) experience of manufacturing, quality, and regulatory documents.

• Working knowledge of regulatory requirements in accordance with cGMP and/or USDA manufacturing operations. Hands on experience with large scale biopharmaceutical processes and equipment, principles, and practices is preferred.

• Planning and execution of DS PPQ activities, including development of PVAC, validation protocols, validation reports.

• Planning and execution of risk assessments, according to FMEA model, including cross-contamination, product quality, raw materials risk assessments.

• Organizationally Savvy, highly motivated to learn and grow, can-do attitude, attention to details, and high ethical standards.

Other:

• Seeking Boston local candidates to be on-site 2-3 days per week.

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required (up to 25%)