Clinical and Health
2 weeks ago
Group: Pharma Services Group
Division: Drug Substance Division
- This position supports the QC Analytical team for our Biologics Division.
- The QC Biochemistry team is compromised of 14 scientists ranging from scientist level 1-2, based on experience and skill.
- As part of the Quality Control Biochemistry Group, you directly impact patients’ lives by providing testing to ensure their biologic pharmaceuticals are safe and potent
- Conduct routine compendial, purity, and impurity testing of pharmaceutical release, stability, and in-process samples by internally developed, qualified, and validated test methods.
- Support qualification and validation of test methods for pharmaceutical concentration, purity, and impurity testing.
- Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
- Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
- Maintain the necessary compliance status required by company and facility standards.
Education:
- Associates Degree with 2 or more years of relevant work experience or a Bachelor’s degree with GPMP laboratory experience, STEM degree preferred, technical skills, a
- HS Diploma or GED required
- 0 - 1 year of experience in the biopharmaceutical or pharmaceutical industry.
- Good knowledge and understanding of chemistry and analytical instrumental technologies
- Good knowledge of qualitative and quantitative chemical or microbiological analysis.
- Good presentation skills to present information to customers, clients, and other employees.
- Routine use of MS Excel, MS PowerPoint, MS Access, and MS Word is essential.
- Ability to write standard operating procedures, simple protocols, and reports.
- Scientific techniques including: Protein Concentration via Shimadzu and SoloVPE, Residual DNA via Real Time PCR (Polymerase Chain Reaction), Capillary Gel Electrophoresis, Imaged Capillary Isoelectric Focusing (iCIEF), Dot Blot, Compendial Testing: pH and osmolality
- This position has not been approved for relocation assistance.
- Our Mission is to enable our customers to make the world healthier, cleaner and safer.
- Watch as our colleagues explain 5 reasons to work with us.
- As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
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