Principal Scientist – Extractables/Leachables Trace Impurities Job at Pace Analytical Services LLC
Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers.
Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We share a common goal to bring real value to people, healthcare professionals, and health businesses around the world. Driven by our commitment to improving our health, we deliver services that offer hope – and a better, safer, and healthier life for everyone.
Pace Life Sciences, Oakdale, is currently looking for a Principal Scientist for their Extractables/Leachables department.
The ideal candidate would have LC-MS and GCMS experience with knowledge and skills in extractable and leachable, other analytical techniques.
Benefits
- 401(k) with matching
- Dental Insurance
- Health Insurance
- Health Savings Account
- Vision Insurance
- Life Insurance
- Paid time off.
Roles and responsibilities
- Guarantees integrity in all aspects of the analytical support provided to our clients
- Continually builds positive, strong relationships with our customers.
- Defines, prioritizes, and honors all internal and external commitments.
- Ensures high-quality data is safely generated in a cGMP-regulated laboratory environment according to a defined plan and delivered on time within a signed scope of work.
- Proactively manages and/or executes the transfer, development, and qualification/validation of analytical test methods and subsequent release and stability testing.
- Serves as a subject matter expert and/or technical lead in multiple areas of testing for current and prospective clients.
- Routinely provides creative and flexible solutions in response to unexpected changes in demand within a fast-paced environment.
- Leads opportunities directed toward departmental stabilization, promoting collaborative teamwork, pursuing offering expansion, and realization of potential resources.
- Continuously drives strategic department improvement initiatives concerning people, equipment, practices, procedures, and policies via the utilization of lean six sigma tools.
Education and Experience
Master's degree in chemistry/biochemistry, biology, or Ph.D.; AND three to seven
years of professional lab experience (Preferred GDP, cGMP labs); OR an equivalent combination of education, training, and experience.
Required Knowledge and Skills
- Knowledge and experience in extractable and leachable testing per ISO-10993, USP <1663>/<1664>, and/or BPOG guidance
- Working experience with UPLC-MS, -MS/MS, -ToF, and GCMS
- Preferred experience with Mass Hunter or UNIFI
- Knowledge and experience with:
- Design and execution of extractions and leachable studies
- Chromatographic separations
- Unknowns analysis
- Polymer chemistries
- Technical writing experience
- Mentoring Associate Scientists
- Method Development and Validation
PHYSICAL/MENTAL REQUIREMENTS:
Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
WORKING ENVIRONMENT:
Work is performed in lab, office, and field settings. Work is subject to exposure to blood or bodily fluids, chemicals, fumes, gasses, noxious odors, and related items in a lab and environmental setting. Work can also be subject to travel.
#STAR
Please Note :
www.epokagency.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.epokagency.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.