AddressDescription
Description:
Bachelors degree preferably in Chemistry Biochemistry or Biology.Perform HPLC/UPLC testing on In-Process DS release DP release DS stability DP Stability process validation analytical method validation/transfer method establishment/qualification and various other non-routine samples. Demonstrate proper laboratory safety and housekeeping practices through weekly 5S Lab audits and monthly laboratory inspections. Assure all activities meet EHS requirements. Conduct GMP testing in an analytical laboratory environment using HPLC and UPLC test methods i.e.Reverse Phase SEC Titer concentration CEX etc.. Accurately record and report analysis results in accordance with lab procedures and quality systems. Recognize and report out-of-specification/ out-of-trend results to laboratory management recommend solutions. Maintain and troubleshoot analytical instrumentation and workspace as needed. Perform method validation and/or qualification testing as needed. Author and/or review SOP's test methods forms and etc. in the document management system eDMS. Perform all duties in compliance with Standard Operating Procedures Good Manufacturing Practices Good Laboratory Practices and Safety guidelines. Work with internal and external customers to ensure clear and open communication is maintained when resolving and raising issues. Collaborate with QC leads PMs and clients to maintain good health of client programs. Minimum of 1 year of HPLC/UPLC experience in quality/analytical/pharmaceutical industry or similar experience.Experience with multitude of HPLC/UPLC assays is a plus SEC CEX Glycans Peptide Map etc.Prior use of EMPOWER is preferred.Knowledge of GMP regulations in cGMP manufacturing environment.Working knowledge of scientific principles for wide range of analytical techniques strongly preferred.
Skills:
HPLC, GMP, chemistry, EMPOWER, SEC, CEX, Glycans, peptide map
Top Skills Details:
HPLC,GMP,chemistry,EMPOWER
Additional Skills & Qualifications:
Strong knowledge and understanding of chemistry and chromatographic analytical instrumental technologies.Good knowledge of quality and regulatory requirements in the pharmaceutical industry.Good problem-solving skills and ability to multi-taskStrong interpersonal and communications skills, written and oral.Ability to read, analyze, and interpret technical procedures and governmental regulations.Ability to write, revise or review procedures, protocols or test methods.Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.Ability to drive functional, technical and operational excellence.
Experience Level:
Entry Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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