QualificationsThe ideal candidate would possess:
- Perform Protein chemistry techniques in a quality environment, such as UPLC, SEC, IEX, Peptide Map, icIEF, reduced CE-SDS, and non-reduced CE-SDS.
- Analyze data and Perform reintegration for chromatography-based methods
- Execute efficiency improvements in areas such as method revisions, method optimizations, reference standard qualification, and control charts.
- Write, revise, and collaborate on technical documents such as SOPs, analytical methods, and method attachments
- Write quality events, deviations, CAPAs, and change requests and perform investigations to support these quality management systems.
- Uses small equipment (pH, osmometer) to support laboratory testing
- Uses a combination of HPLC, UPLC, CE, and iCE3 instrumentation to support laboratory testing
- Regularly analyzes and presents topics to project groups
- May introduce new QC methodologies and is able to refine methods, with supervisory input
- Demonstrate a high level of compliance with cGMP and company documentation practices
- Performs periodic maintenance and qualification of laboratory equipment and works on special projects as determined by the supervisor
- Maintain compliance with all required training
- Experience with testing, analyzing, and optimizing GMP chromatography methods including HPLC / UPLC, peptide methods, and CE-SDS.
- Understanding of data integrity requirements for GMP operations, including 21CFR Part 11 and GAMP 5.
- Experience with data integration using Chromelion software
- Demonstrated ability to work effectively on cross-functional teams
- Strong organizational and project management skills, including technical writing and presentation of technical data.
- Experience with relevant analytical lab equipment and computers.
- Ability to understand analytical/technical data.
- Excellent communication and interpersonal skills.
- Ability to interact constructively with coworkers and other departments.
- Working knowledge of MS Word, Excel and PowerPoint.
- Good organizational skills and excellent attention to detail, ability to multi-task
Additional InformationWhat We Offer
- BS in Chemistry, Biochemistry, or other science degree with related experience
- 2+ years of experience performing relevant cGMP analytical methods
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Comprehensive medical coverage, with dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid holidays and vacation
Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.We are looking forward to receiving your application including your expected salary and possible start date via our career website.Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.