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Description:
- Conduct routine compendial purity and impurity testing of pharmaceutical release stability and in-process samples by internally developed qualified and validated test methods.
- Utilize UV/VIS, CGE, capillary gel electrophoresis, imaged capillary isoelectric focusing for testing samples.
- Work in a regulated environment following GMP, cGMP.
- 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.
- Bachelors degree
- Minimum 1 year of experience in the biopharmaceutical or pharmaceutical industry.
- knowledge and understanding of chemistry and analytical instrumental technologies
- knowledge of qualitative and quantitative chemical or microbiological analysis.
Skills:
Capillary Gel Electrophoresis, Imaged Capillary Isoelectric Focusing, uv/vis, EMPOWER, stability testing, protein concentration, Quality control
Additional Skills & Qualifications:
- 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
- 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.
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.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
