GMP Analytical Chemist
About The Position
Ability to work in a GLP or GMP environment with appropriate documentation and safety practices. Responsible for utilizing analytical methodologies, systems and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout all phases of development. This may include excipient, packaging and post packaging support Analytical testing would include: compendial testing (e.g., excipients / packaging release testing), disintegration, dissolution, HPLC/UPLC, SFC, generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methods Set up and analysis of drug substance and drug product stability samples Method development and validation of analytical methods for drug substance and drug product
Requirements
- Bachelor’s degree in science or other related degree concentration, or equivalent directly related experience
- Strong computer, scientific, and organizational skills
- Experience with eLN, LIMS, and data trending is a plus
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivated, adaptable, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Authorization to work in the United States indefinitely without restriction or sponsorship
Nice To Haves
- Experience in a GMP laboratory, analytical chemistry preferred
- Experience with eLN, LIMS, and data trending
Responsibilities
- Work in a GLP or GMP environment with appropriate documentation and safety practices.
- Utilize analytical methodologies, systems and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout all phases of development. This may include excipient, packaging and post packaging support
- Perform analytical testing including: compendial testing (e.g., excipients / packaging release testing), disintegration, dissolution, HPLC/UPLC, SFC, generic testing (e.g., solvents, water, ash, titrations, heavy metals, ICP/MS, UV) and compound specific methods
- Set up and analysis of drug substance and drug product stability samples
- Perform method development and validation of analytical methods for drug substance and drug product
Benefits
- comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
