Principal Scientist: Small Molecule Analytics & cGMP Lead

BioSpace; Rahway (NJ); On-site; USD 130,000 - 190,000; Full time

Job summary

BioSpace seeks a Principal Scientist to lead analytical method development and validation within the ACT group in ACSD at Rahway, NJ and West Point, PA. The role focuses on late-stage small molecule drug product development and commercialization, mentoring a team, and coordinating cross-functional regulatory activities.

The successful candidate will drive method transfer, regulatory documentation, and collaboration across technical, regulatory, research and manufacturing teams to ensure

Qualifications

• PhD in Analytical Chemistry or related discipline with seven or more years of relevant small molecule pharmaceutical development experience; OR MS with ten or more years.
• Strong background with UHPLC/HPLC, Dissolution, GC, UV/IR spectroscopy, and Karl Fischer titration.
• Experience with method development and validation and regulatory CTD submissions (IND, NDA, MAA, JNDA).
• Mentoring and leading teams; effective cross-functional collaboration.

Responsibilities

• Lead analytical method development and validation for drug products in a cGMP environment.
• Oversee drug product and manufacturing process characterization and stability studies.
• Prepare CMC documents for global regulatory submissions and respond to questions.
• Mentor scientists and build scientific capabilities within the organization.
• Coordinate development efforts across multi-project portfolios.

Education

PhD in Analytical Chemistry

Tools

UHPLC/HPLC

Dissolution

GC

UV/IR spectroscopy

Karl Fischer titration

Job description

BioSpace seeks a Principal Scientist to lead analytical method development and validation within the ACT group in ACSD at Rahway, NJ and West Point, PA. The role focuses on late-stage small molecule drug product development and commercialization, mentoring a team, and coordinating cross-functional regulatory activities.

The successful candidate will drive method transfer, regulatory documentation, and collaboration across technical, regulatory, research and manufacturing teams to ensure