MSAT Technical Lead – Drug Substance, Senior Manager

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

📋 Description

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

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

• Lead and implement MSAT projects aimed at enhancing manufacturing processes and reducing costs as part of the lifecycle management (LCM).

• Engage in internal functions related to (external) manufacturing, including process alterations, significant deviations, risk assessments, and corrective and preventive actions (CAPAs).

• Generate, review, and authorize relevant internal and external standard operating procedures (SOPs) and manufacturing guidelines.

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

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

• Draft and assess applicable sections in registration documents, variations, and market expansion efforts.

• 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, scaling up activities, validations, and supervise the manufacturing of Small Molecules processes at external manufacturers for Sobi projects during clinical and commercial phases.

• Stay informed about advancements in external biopharmaceutical manufacturing technologies, comprehend and implement new technologies, and evaluate their potential impact on process innovation, cost efficiency, or yield enhancement.

⛳️ 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 context, leading the technical components of product transfers, scale-up, and validation.

• Demonstrate experience in reviewing relevant sections of the APR/PQR.

• Possess a scientific and technical background in Chemistry, Manufacturing, and Controls (CMC) development and manufacturing of drug substances, specifically small molecules.

• Have experience with regulatory guidelines, communication with regulatory bodies, and documentation of files.

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

• Exhibit proven experience working within a cross-functional team, with the ability to manage multiple tasks, prioritize effectively, and make informed decisions.

🏝️ Benefits

• Competitive remuneration for your contributions.

• Generous vacation policy.

• Opportunities to expand your knowledge by attending prominent conferences.

• A strong focus on maintaining work/life balance.

• A collaborative and team-oriented work environment.