MSAT Technical Lead – Drug Substance, Senior Manager

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

📋 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 focused on manufacturing process enhancements and cost reductions as part of Lifecycle Management (LCM).

• Engage in internal activities associated with (external) manufacturing, including process modifications, significant/critical deviations, risk evaluations, and CAPAs.

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

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

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

• Compose and assess applicable components in registration documents, variations, and market expansion efforts.

• Assist in sourcing evaluations for new Small Molecules contract manufacturers and contribute to the development of supply and quality agreements.

• Direct the technical aspects of product transfers, scale-up initiatives, validations, and monitor 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, recognize and integrate new technologies, and their potential impact on process innovation, cost, or yield improvements.

⛳️ Requirements

• Degree in Chemistry, Biology, Biotechnology, Pharmacy, or a related field.

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

• More than 3 years of experience in a commercial environment, leading the technical aspects of product transfers, scale-ups, and validations.

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

• Strong scientific and technical expertise in CMC development and the manufacturing of drug substances, particularly small molecules.

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

• Experience managing external vendors such as CMOs and CDMOs.

• Proven ability to work within a cross-functional team, demonstrating multitasking, prioritization, and effective decision-making skills.

🏝️ Benefits

• A competitive 401(k) match to support your financial future.

• Tuition and wellness reimbursements to invest in your personal and professional growth.

• A comprehensive medical, dental, and vision package to prioritize your health and well-being.

• Additional recognition awards to celebrate your achievements.