Manufacturing, Science and Technology Lead

📋 Description

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

• Supervise all technical aspects of drug product manufacturing (fully compliant with GMP) for a small molecule produced by an external manufacturer.

• Direct the technical workstreams involved in transferring products from development to commercial sites, coordinating scale-up activities, process validations, and overseeing the manufacturing of drug products with small molecules at external facilities for both clinical and commercial projects.

• Lead internal initiatives concerning external manufacturing, including assessments of process changes, major and critical deviations, risk evaluations, and corrective and preventive actions (CAPAs).

• Review and manage the establishment, execution, and documentation of technical studies related to DP (CMC development and commercial operations), as well as process and equipment qualifications and validations.

• Draft and evaluate relevant sections in registration files, variations, and market expansions.

• Issue, review, and approve applicable 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 made to them.

• Assist in the sourcing evaluation of new small molecule drug products, identify alternative contract manufacturers utilizing hard-gelatine capsules, and participate in the development of supply and quality agreements.

• Stay informed about advancements in external manufacturing technologies, understand, and implement new technologies that may enhance process innovation, cost efficiency, or yield improvement.

⛳️ 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 clinical and commercial applications.

• A recognized authority in the manufacturing of hard-gelatine capsules for drug products.

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

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

• Experience working with external manufacturers.

• Familiarity with regulatory guidelines (FDA & EMA) and experience in communication with regulatory authorities and filing documentation.

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

🏝️ Benefits

• Competitive compensation for your contributions.

• Generous time-off policy.

• Opportunities to expand your knowledge by attending renowned conferences.

• Strong emphasis on work/life balance.

• A collaborative and team-oriented work environment.

• The chance to make a positive impact in the lives of patients with ultra-rare diseases who require life-saving treatments.