Eastern Potential. Western Performance.

Job: Formulation Director

Title

Formulation Director

Categories

China, Formulation, Product Development, Scientific

Reporting To

SVP Product Development / COO China Operations

Location

Suzhou, China

Specific Responsibilities

  • 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.

Apply Now

Suzhou Pharma Services

In China:
No.58, Qunxing Yi Road,
Suzhou Industrial Park, PRC. 215006
Contact: Julie Gu
jgu@suzhoupharma.cn
+86-512-6745-1085 ext 101

In the US:
9 Polito Ave, Suite 900
Lyndhurst, NJ 07071
Contact: Michelle Valsera
mvalsera@suzhoupharma.cn
(732) 993-9827