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) involving small molecules used in non-sterile dosage forms.

• Manage all technical aspects of drug product manufacturing (fully compliant with GMP) for a small molecule produced at an external manufacturing site.

• Direct the technical workstreams involved in product transfers from development to commercial sites, including transitions between commercial facilities, scale-up operations, process validations, and oversee the manufacturing of Drug Products with small molecules at external manufacturers for both clinical and commercial projects.

• Lead internal initiatives concerning external manufacturing, which include process change assessments, major/critical deviations, risk evaluations, and corrective and preventive actions (CAPAs).

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

• Compose and review relevant sections in registration files, variations, and market expansions.

• Issue, review, and approve pertinent 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 modifications to these.

• Assist in the evaluation of new small molecule Drug Product sources, hard-gelatin capsule-based alternative contract manufacturers, and participate in the development of 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 involving small molecules for both clinical and commercial applications.

• A recognized authority in the manufacturing of hard-gelatin capsule drug products.

• Strong 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 groups, prioritize tasks, and make effective decisions.

• Familiarity with working alongside external manufacturers.

• Knowledge of regulatory guidelines (FDA & EMA), communication with regulatory authorities, and documentation for filings.

• Proficiency in English; intermediate to advanced proficiency in Chinese is an advantage.

🏝️ Benefits

• Competitive salary for your contributions.

• Generous leave policy.

• Opportunities to expand your knowledge by attending prominent conferences.

• Focus on maintaining a healthy work/life balance.

• A collaborative, team-oriented workplace environment.