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.