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 Job #02903 Email this job to a friend
About our client
Our client is a rapidly growing technology-focused company based in Cincinnati. They deliver a fast and integrated way of moving drug candidates from discovery through to clinical trials up to commercial API production. The company has an experienced management team, a strong pipeline of compounds and two state-of-the-art facilities in Ohio and Germany.
Position Location
Analytical Scientist/Analytical Chemist Cincinnati, Ohio
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Develop separations for the analysis of DNA and RNA using chromatography (ion-pair, anion exchange and size exclusion) and capillary gel electrophoresis
2) Develop and implement methods for the chemical and physical testing of raw materials, in-process intermediates and final oligonucleotide API
3) Validate release methods for active pharmaceutical ingredients
4) Use analytical skills to support Oligonucleotide Manufacturing Group
5) Participate in client site visits, teleconferences and audits
6) Maintain accurate and complete lab notebooks
7) Write analytical laboratory SOPs, protocols and compliance documents
8) Oversee laboratory investigations
9) Participate in cGMP training and implement cGMP operating procedures
10) Oversee troubleshooting of analytical problems, and technology transfer of analytical methods for new and existing drug substance to other laboratories
11) Participate and contribute to safety programs
12) Perform instrument audits
13) Maintain an orderly and safe laboratory environment
14) Review laboratory documentation for calculation, entry and GMP compliance
15) Solve (independently) complex, non-routine analytical and product problems
16) Develop and/or modify test methods
17) Train BS/MS-level chemists
Requirements
1) Ph. D. or MS with specialization in Analytical Chemistry
2) 3+ years of experience in analysis of oligonucleotides
3) In-depth knowledge of separation techniques (HPLC, GC and CGE)
4) Knowledge of oligonucleotide analysis techniques
5) Understanding of cGMPs
6) Excellent communication skills (oral and written)
7) Superb interpersonal skills
8) Ability to work in a fast-paced manufacturing environment
9) Ability to work in teams with a diverse group of professionals
10) Focused on timelines and meeting project objectives
11) Self-starter and continuous learner

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