Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our Company's extensive range of products from candidate selection to market authorization
Job Summary
Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our Company's extensive range of products from candidate selection to market authorization.
The role involves developing and performing analytical methods for raw materials testing, authoring and maintaining Standard Operating Procedures, supporting instrument qualification, and collaborating with production for timely, compliant raw material release for clinical batch production.
We offer a comprehensive package of benefits including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and compassionate and sick days.
Matching Summary
Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our Company's extensive range of products from candidate selection to market authorization.
Salary
Base: $117,000.00 - $184,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive if applicable; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, and sick days
Skills & Requirements
Must-have
Good Manufacturing Practices (GMP)
Analytical method development
Raw material testing
Instrument qualification support
Technical problem solving
Scientific oversight
Compliance audits support
Nice-to-have
Leadership and communication skills
Experience with LIMS and Empower
Knowledge of data integrity principles
Continuous improvement methodologies
Cross-functional collaboration
Positive attitude and self-motivation
Hybrid work environment
Key Requirements
Ph.D. in biology, chemistry, biochemistry or related field or M.S. with 3+ years experience or B.S. with 7+ years experience
Experience in pharmaceutical raw materials testing
GMP experience and understanding of data integrity principles
Knowledge of cGxP, USP, EP, ICH, FDA guidelines
Analytical method validation and lifecycle management
Deviation management and change control experience