MSAT Technical Lead – Drug Substance

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

📋 Description

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

• Responsible for the process validation of Small Molecules for Sobi products.

• Lead and implement MSAT projects, focusing on manufacturing processes and cost improvements as part of Lifecycle Management (LCM).

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

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

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

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

• Create and assess necessary components in registration files, variations, and market expansion efforts.

• 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, 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, and introduce new technologies that could enhance process innovation, cost, or yield improvements.

⛳️ Requirements

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

• Over 10 years of experience in the development and manufacturing of small-molecule drug substances for both clinical and commercial applications.

• More than 5 years of experience in a commercial environment leading the technical aspects of product transfers, scale-up, and validations.

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

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

• Knowledgeable in regulatory guidelines, communication with regulatory authorities, and documentation of files.

• Experienced in overseeing external vendors, including Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs).

• Proven ability to work within a cross-functional team, demonstrating skills in multitasking, prioritizing, and making effective decisions.

🏝️ Benefits

• Competitive compensation for your contributions.

• Generous time-off policy.

• Opportunities for professional development through attendance at prominent conferences.

• Strong emphasis on work/life balance.

• A collaborative and team-focused environment.

• The chance to make a positive impact by assisting ultra-rare disease patients in need of life-saving treatments.