Analytical Chemist
About The Position
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
- Strong computer, scientific, and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivated, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Bachelor’s degree in chemistry or other science related degree concentration, or equivalent directly related experience
- Authorization to work in the United States indefinitely without restriction or sponsorship
Nice To Haves
- Experience with eLN, LIMS and data trending
- Laboratory experience and some experience in GMP analytical chemistry, preferred
Responsibilities
- 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.
- 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
- 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
