UPM is a service organization and our employees are our greatest asset. This is why we seek highly skilled and highly motivated individuals to become a part of our team. We look for people that share a passion for the pharmaceutical industry as well as for hard work, creativity, and growth. Our employees are devoted to our mission of rapidly advancing pharmaceutical technologies and products on behalf of our clients. At the same time, we work in an enriching environment, work as a team where initiative and performance is rewarded. If you share our commitment to teamwork, enjoy a challenge, and want to feel good about the work you do, please contact UPM at firstname.lastname@example.org to discuss our current open positions.
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Analytical Development Scientist
UPM Pharmaceuticals, Inc., a contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking an Analytical Development Scientist that leads in the development of new analytical methods.
Essential Duties and Responsibilities
- Transfers or develops & validates analytical methods including requisite method protocols, optimization and technical reporting for APIs, drug products, excipients, and raw materials
- Assists with or develops Standard Operating Procedures, robust Quality Control testing methods/procedures and coordinates transfer of methods into Quality Control group
- Participates in the planning and execution of raw material, components, and vendor qualification or alternate supplier analytical qualification studies.
- Critical scientific/technical data analysis and presentation including analytical development representation on customer-focused project teams, as appropriate
- Often assists with drug product, stability and residual testing under applicable regulations (e.g. ICH, FDA, EMA) or analytical testing for manufacturing process validation
- Stays up-to-date on current research literature, industry practice and applicable regulatory requirements
- Assists routine maintenance, calibration, and performance verification on applicable instruments
- Complies with all applicable policies regarding health, safety and environment
Bachelor’s Degree in Chemistry or related science field and a minimum of 2 years relevant experience including method development (university internships do not meet this criteria). Knowledge of good laboratory practices, cGMP, USP methodology, FDA, ICH, OSHA, DEA regulations, and MSDSs are desired.
Qualifications and Skills
Technical Knowledge – Strong theoretical and practical knowledge of analytical method development under cGMP regulated processes. Experience with HPLC, GC, UV/VIS, wet chemistry and USP/NF compendial methods are highly desirable. Experience with Empower chromatography software is a major bonus.
Computer Skills – Familiar with MS Office applications and data analysis software.
Communication – Strong interpersonal skills with excellent oral and written communication skill is required.
Adaptability – Ability to think critically and creatively in a highly dynamic environment to solve serious scientific problems. Effectively manages competing demands; able to deal with unexpected delays or events.
Dependability – Perfect candidate must be highly self-motivated and organized with demonstrated ability to prioritize, manage and schedule work within a high performing, high throughput laboratory environment to meet project deadlines in a Quality fashion. Attention to detail is a must.Inquire about This Job >>