Manufacturing, Science and Technology Drug Product Lead

📋 Description

• Act as the subject matter expert (SME) and process owner for the manufacturing of Drug Products (DP) related to a small molecule utilized in non-sterile dosage forms.

• Manage all technical aspects of drug product manufacturing (strictly adhering to GMP) for a small molecule produced at an external manufacturing site.

• Lead the technical workstreams for product transfers from development to commercial sites and between commercial locations, including scale-up activities, process validations, and overseeing the manufacture of Drug Products with small molecules at external facilities for both clinical and commercial projects.

• Direct internal activities associated with external manufacturing, including process change assessments, major/critical deviations, risk assessments, and Corrective and Preventive Actions (CAPAs).

• Review and supervise the setup, execution, and documentation of DP-related technical studies (CMC development and commercial operations), along with process and equipment qualifications and validations.

• Draft and review relevant sections of registration files, variations, and market expansion documents.

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

• Contribute to the establishment of new analytical specifications and stability programs, and review any changes made.

• Assist in evaluating sourcing options for new small molecule Drug Products, including hard-gelatin capsule-based alternative contract manufacturers, and participate in developing supply and quality agreements.

⛳️ Requirements

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

• Over 10 years of experience in the development and manufacturing of oral dosage forms and drug products containing small molecules for clinical and commercial applications.

• A recognized authority in the manufacturing of hard-gelatin capsule Drug Products.

• A solid scientific and technical background in CMC development and GMP-compliant manufacturing for small molecule drug products.

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

• Experience collaborating with external manufacturers.

• Familiarity with regulatory guidelines (FDA & EMA), as well as communication and documentation requirements for regulatory authorities.

• Proficiency in English, with intermediate to full proficiency in Chinese considered an advantage.

🏝️ Benefits

• Competitive compensation for your contributions.

• Generous time-off policy.

• Opportunities to expand your knowledge by attending well-known conferences.

• A strong focus on work/life balance.

• A collaborative and team-oriented workplace environment.