Director, Analytical Development /Support – Somerset, NJ 08873

Director, Analytical Development /Support

About our company:

Odin Pharmaceuticals is a generic pharmaceutical company situated in the town of Somerset in Central New Jersey. The company develops small molecules and peptides in difficult-to-develop and difficult-to-manufacture dosage forms for injectable and ophthalmic administration. The company is affiliated with Somerset Therapeutics, a company that manufactures and markets several injectable and ophthalmic products.

About the position:

We seek a PhD-level organic analytical chemistry leader with excellent peptide as well as small molecule analysis expertise to advance peptide and small molecule drug development in the laboratory. The successful candidate is a proven leader who will work cross-functionally with the internal analytical team, internal product development team, and external API suppliers to generate analytical methods for the submission of ANDAs.

Responsibilities include lead and direct a team of scientists working in*:

· Development and validation of LC, LC/MS, GC, GC/MS, ICP-MS and other wet chemical methods for actives, impurities, extractables/leachables, degradation and related compounds in drug products and accelerated stability samples

· Preparation and review of method validation protocols and validation reports

· Operation and maintenance of LC, GC, LC-MS, GC-MS, ICP-MS (Thermo Finnigan instruments) and other instruments needed for impurity characterization

· Develop analytical methods for peptide characterization using SEC, SEC-MALLS, SDS-PAGE/CE-SDS, RLD, AUC, FFF, Photon Correlation Spectroscopy (PCS) and LC/MS

· Draft, review, and approve analytical reports

· Write scientific response to CMC Deficiencies from the FDA

· Review and evaluation of drug substance supplier’s technical documents

· Identification of specification requirements for drug substances and critical raw materials and approval of specifications and specification justifications

· Maintain the instruments used for the physical characterization of powders and dissolution apparatus

*Responsibilities will be more comprehensive for more senior positions

Requirements:

· 5-15 years’ experience in peptide analysis at a scientific organization; experience at a pharmaceutical company preferred

· Exceptional knowledge of organic chemistry, peptide chemistry in particular, and wet chemistry analysis

· Track record of scientific contributions; publications and patents preferred

· Experience in mentoring and guiding junior scientists

· Flexible, optimistic attitude

Job Type: Full-time

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan

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