MSAT Technical Lead – Drug Substance, Senior Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Serve as the subject matter expert (SME) for Small Molecules Drug Substance Manufacturing.

• Act as the process owner for Small Molecules process validation specific to Sobi products.

• Lead and implement MSAT projects aimed at improving manufacturing processes and cost efficiency as part of Lifecycle Management (LCM).

• Engage in internal activities concerning (external) manufacturing, including process modifications, significant deviations, risk assessments, and Corrective and Preventive Actions (CAPAs).

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

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

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

• Write and assess applicable sections in registration documents, variations, and market expansion initiatives.

• Assist in the evaluation of 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, validations, and supervise 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, understand their implications, and introduce new technologies that may enhance process innovation, cost, or yield improvement.

⛳️ Requirements

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

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

• Have at least 3 years of experience in a commercial environment, managing the technical components of product transfers, scale-up, and validation.

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

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

• Familiarity with regulatory guidelines, communication with regulatory authorities, and documentation for filings.

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

• Proven ability to work within a cross-functional team while effectively multitasking, prioritizing tasks, and making informed decisions.

🏝️ Benefits

• Competitive compensation for your contributions.

• Generous time-off policy.

• Opportunities to expand your knowledge by attending renowned conferences.

• Focus on maintaining a healthy work/life balance.

• A collaborative and team-oriented workplace culture.

• Make a meaningful difference by helping patients with ultra-rare diseases access life-saving treatments.