Head of Formulation

Responsibilities

·       Provide strategic leadership, technical expertise, an d specialized knowledge in formulation development to support testing of new drug products （large molecules an d small molecules）.

• Write and/or review protocols,      final development reports, batch records, standard operating procedures,      and other technical reports to support regulatory filings.

• Responsible for understanding      and applying data generated from experiments used to modify/optimize      formulations an d process parameters.

• Work effectively in a      cross-functional matrix environment, with internal an d external customers      and proactively communicate with internal an d external stakeholders.

• Ensure all tasks are performed      according to approved development protocols an d batch records.

• Author an d review appropriate      CMC sections of IND an d NDA submissions.

• Direct technology transfer      to/from contract manufacturing organizations an d provide technical      oversight of production of early stage drug products for GLP an d clinical      studies.

• Provide technical leadership in      ensuring that vendor-manufacturing facilities are compliant with cGMP an d      foster relationships with CMOs an d Contracting Testing Laboratories      （CTOs）, including the review an d approval of test records, forms, methods,      protocols an d reports, to ensure that data an d products meet requirements      and all appropriate laws an d regulatory requirements.

Qualification

• Degree in chemistry,      pharmaceutical development Ｏr other scientific discipline, Ｏr Ph.D., Ｏr      equivalent work experience related to biology Ｏr CMC preferred

• 10 years Ｏr more in the      pharmaceutical industry with a minimum of 8 years in formulation      development area. Prior management experience preferred

• Ability to establish an d      maintain effective working relationships

• Ability to effectively      prioritize an d deliver on tight timelines

• Outstanding problem-solving      abilities

• Detail-oriented, with good      organizational an d project management skills

• Excellent oral an d written      communications skills

• Proficient with MS Word,      PowerPoint, Excel