Director of Product Development
Job Description
Prinston Pharmaceutical Inc. is looking for a qualified candidate with
pharmaceutical industry experience to take on the role of Director of
Product Development to support its product R&D efforts.
Key Responsibilities:
-
Lead the Product Development (PD) department to develop new
pharmaceutical products in the R&D product portfolio from project
kickoff through commercialization. Activities include but not limited
to:
-
Leverage understanding of the scientific principles of
pharmaceutical sciences to design and develop finished dosage forms
and manufacturing processes to achieve product development goals. At
the current stage, the products are primarily generic drug products
(ANDAs).
-
Guide formulators to conduct literature search, formulation and
manufacturing process development for new ANDA products following
QbD principles.
-
Review data, scientific literature and provide directions and
solutions to solve product development problems.
-
Work closely with analytical R&D counterpart to ensure that all
methods development, brand drug product characterization studies,
prototypes quality and stability testing, and establishment of
product quality specifications are carried out in a timely manner to
support successful new ANDA product development.
-
Provide leadership in technology transfer, manufacturing process
scale-up and submission batch manufacturing.
-
Work closely with Technical Operations and Manufacturing team within
Prinston Pharmaceutical and at CDMOs to conduct process scale-up
studies and manufacturing of submission batches.
-
Review/approve and supervise direct reports to review/approve batch
records, protocols, in-process control/finished product
specifications and reports for all products developed for ANDA
filing with the FDA.
-
Support ANDA filing and Post-Approval Supplement initiatives.
-
Guide formulators to draft relevant sections of the ANDA documents
for filing with the FDA.
- Review relevant sections of the ANDA documents for filing.
-
Provide inputs and organize studies to generate data needed for
developing responses to address the FDA ANDA deficiencies.
-
Provide inputs to support PAS initiatives for approved products led
by Product Management.
-
Lead and manage the control substance program at the Prinston
Pharmaceutical R&D laboratories
-
Maintain control substance program status, including laboratory
security, documents, and licenses related renewals and updates.
-
Manage the Product Development Laboratory
-
Ensure the safety guidelines are followed for all product
development activities.
-
Ensure the equipment capability and capacity are adequate and ready
to support in-house product development projects.
-
Mentor and manage direct reports including handling their objectives
setting and performance reviews.
-
Provide scientific and technical input for new product evaluation to
support Portfolio Management.
Requirements:
-
A self-motivated professional with strong verbal and writing skills who
can effectively communicate with peers.
-
Ph.D. in Pharmaceutics, Pharmaceutical Engineering, Chemistry, Chemical
Engineering, or other relevant scientific fields.
-
Oral solids dosage forms experience (i.e., immediate release, delayed
release and extended release) required. Injectables and complex generic
experience (i.e., injectables, topicals) are a plus.
-
Working knowledge of major pharmaceutical processing technologies and
cGMP requirements for different pharmaceutical dosage forms.
- DEA scheduled compound product development experience is a plus.
Benefits:
- Medical, dental and vision insurance.
- 401k match.
Please send your resume to jobs@prinstonpharm.com, with the job title in
the subject.