MSAT Technical Lead – Drug Substance, Sr Manager

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Act as the subject matter expert (SME) for the manufacturing of Small Molecules Drug Substances.

• Serve as the process owner for the validation of Small Molecules processes related to Sobi products.

• Lead and implement MSAT projects aimed at enhancing manufacturing processes and reducing costs as part of Life Cycle Management (LCM).

• Engage in internal activities associated with (external) manufacturing, including process modifications, handling major/critical deviations, conducting risk assessments, and managing CAPAs.

• Issue, review, and approve relevant internal and external Standard Operating Procedures (SOPs) and manufacturing instructions.

• Oversee the planning, execution, and documentation of technical studies, qualifications, and validations.

• Draft and evaluate applicable sections of the Annual Product Review/Product Quality Review (APR/PQR).

• Compose and assess relevant content in registration files, variations, and market expansion documentation.

• Assist in the evaluation of potential new Small Molecules contract manufacturers and contribute to the development of supply and quality agreements.

• Lead the technical aspects of product transfers, scale-up activities, and validations, while supervising the manufacturing of Small Molecules processes at external manufacturers for Sobi projects in both clinical and commercial phases.

• Stay informed about advancements in external biopharmaceutical manufacturing technologies, comprehend their relevance, and introduce new technologies to drive process innovation, improve costs, or enhance yield.

⛳️ Requirements

• A university degree in Chemistry, Biology, Biotechnology, Pharmacy, or a related field.

• A minimum of 6 years of experience in the development and manufacturing of small-molecule drug substances for both clinical and commercial applications.

• At least 3 years of experience in a commercial environment, focusing on the technical aspects of product transfer, scale-up, and validation.

• Experience in reviewing relevant sections of the APR/PQR.

• A solid scientific and technical foundation in CMC (Chemistry, Manufacturing, and Controls) development and manufacturing of drug substances and small molecules.

• Familiarity with regulatory guidelines, communication with regulatory authorities, and documentation processes.

• Experience in managing external vendors such as Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs).

• Proven experience working within cross-functional teams, demonstrating the ability to multitask, prioritize effectively, and make sound decisions.

🏝️ Benefits

• Competitive remuneration for your contributions.

• Generous paid time off policy.

• Opportunities to expand your knowledge by attending prominent conferences.

• Strong focus on maintaining a healthy work/life balance.

• A collaborative and team-focused work environment.