|| Formulation Director
||China, Formulation, Product Development, Scientific
|| SVP Product Development / COO China Operations
- Developing formulation approaches for selected product candidates, factoring in technical, regulatory and intellectual property considerations.
- Ensuring timely completion of new product development activities, such as: preformulation; developing stable and bioequivalent formulations; developing manufacturing processes for ANDA registration batches; overseeing all ANDA registration batch manufacturing; and authoring, reviewing and approving technical documents such as protocols, batch records, specifications and development reports.
- Working with operations to manage scale-up, process development and validation.
- Advising operations and quality as to the possible impact that deviations from prescribed operating instructions may have on products.
- Developing, interpreting and explaining standard operating procedures and ensuring compliance.
- Managing, training and developing scientific staff. Maintaining effective communication within areas of responsibility.
- Responsibility and authority for matters such as maintaining quality, accuracy and quantity of work; giving advice, guidance and direction; dealing with routine problems; developing detailed internal work methods; and initiating recommendations on personnel matters.
- Monitoring and appraising performance of subordinate staff.
- Overseeing and collaborating with external partners involved with formulation development and/or manufacturing.
|Desired Skills & Experience
- BA/BS in pharmacy, life sciences or a related discipline.
- An advanced degree such as a Masters, PharmD or Ph.D in pharmaceutical sciences or a related discipline is strongly preferred.
- At least 8 years of experience in drug development in the pharmaceutical industry, with a focus on formulation, process development and scale-up, and a track record of progressively increasing responsibility.
- Experience with complex oral solid formulations in the generic industry would be a distinct advantage.
- Excellent understanding of FDA regulations and GMP.
- Excellent interpersonal, supervisory, investigative and implementation skills.
- Must have a desire to work and excel in a rapidly changing, small company environment where a “hands-on” approach is required.
- Must have strong leadership skills and the ability to positively influence others.
- Demonstrated ability to work effectively in a team environment, manage multiple priorities, exercise sound judgement, be well organized, take the initiative, be flexible, work well under pressure and produce accurate and timely work.
- Ideally fluent in both English and Mandarin.