Sr. Research Associate (Food Supplements)
The main responsibilities of this position will include development of assays for characterization and lot release of food supplement products. In addition, this position will be responsible for executing technical transfers to internal and external parties, requiring close interaction with colleagues in PGS’s Research group as well as external CROs and CMOs. The successful candidate will have significant, broad based experience in analytical separations and detection technologies.
- Under general guidance, design and execute experiments, including assay development and qualification protocols
- Execute internal and external assay technical transfers
- Write technical reports as necessary to document completed work packages and to support regulatory filings
- Represent Analytical Development group across organization (including participation in matrixed drug development teams) and to external partners
- Effective communication and timeline management
- Perform other duties, as assigned
- BS/MS in a scientific discipline with 6 years of relevant industry experience
- Significant hands on experience with HPLC (RP, SEC, and IEX) and electrophoresis (SDS-PAGE, CE)
- Significant method development experience
- Prior experience executing assay tech transfers
- Familiarity with ICH standards for method validation
- Excellent verbal and written communication skills.
- Proven ability to work independently as well as to collaborate with peers and work effectively in team-oriented environment; highly organized
- Hands on experience with LC-MS based detection
- Expertise in structural characterization of protein, nucleic acids, and/or lipid nanoparticles
- Prior experience managing relationships with contract research organizations or research institutions
- Hands on method validation experience
- Results Oriented – Drives issues to closure and gets the job done.
- Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
- Effective Planning - Embedding discipline and thoroughness in our approaches.
- Adaptive at Obtaining Critically Needed Skills – Ability to recognize gaps and quickly learn skills necessary for success.
- Communication and Teamwork – Effectively expresses ideas in written, visual and oral context. The ability to work cooperatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.