Principal Scientist

Minnesota, US
Posted 2 days ago by FPC Raleigh

Job Description

Well-established and expanding generic pharmaceutical company is seeking to hire an analytical development scientist who has significant experience with the development of ANDA products.

Key responsibilities:

1) Manage all analytical development activities for drug substance and drug product for successful ANDA submission (some of these activities are outsourced to CROs

2) Development of analytical strategy - propose timelines and ensure deadlines are met for analytical deliverables.

3) Manage a team of technicians (indirect reports)

4) Propose analytical specifications in compliance with current FDA guidelines/USP monographs

5) Develop and implement stability protocols

6) Lead investigations

Requirements:

BS with 15+ years/MS with 12+ years or Ph.D. with 10+years of pharmaceutical industry GMP analytical development/validation experience (ANDA strongly preferred)

Must have previous experience leading analytical programs from project initiations to FDA submission

Must have prior project management leadership experience

Must have previous experience with authoring portions of regulatory ANDA submissions

Excellent communication skills

Ability to work on cross-functional teams

I look forward to hearing from you if you have this background and experience. My client will consider H1-B transfer for a well-qualified candidate.

Joanne Gehas, Ph.D.
Executive Recruiter

FPC of Raleigh

Recruiters Details

Location:
Minnesota, US
Job number:
J56854-RALE
Recruiter:
Joanne Gehas
Office:
Raleigh
Posted At:
2 days ago
Relocation:
Yes
Job Function:
Analytical Chemistry, Chemist, Product Development, Research & Development, Scientist
Industry:
Pharmaceutical
Education:
BS, MS, PhD