The scope of support activities that this group offers includes: tech transfer, technical support for complex analytical and process investigations, supporting the design approaches for process validation in conjunction with operations teams, assessment and support of on market products in the areas of non-conforming materials, line extensions and second sourcing activities.
This Scientist will primarily be responsible for laboratory activities (compatibility studies. Method transfer, method remediation and impurity ID) for assigned projects. This individual also will prepare and review technical documents, including validation protocols/ reports and test procedures. Independently performs all technical assignments, and is able to troubleshoot analytical instrumentation.
The Ideal Candidate would possess:
Proficient in HPLC/UPLC testing and method development.
Expertise with impurity ID for small molecules using LC-MS.
Support developmental and exhibit batch testing, as well as other studies to support regulatory submissions.
Support the development of HPLC/UPLC methods.
Support the identification of unknown compounds using mass spectrometry.
When required perform experiments in accordance with cGMP regulations, established business processes and protocols, and applicable SOP's.
Document laboratory work that is detailed, timely and in compliance with GSP/GMP requirements.
Conduct technical data reviews, and present data interpretation and conclusions to customers for making informed decisions.
Prepares and reviews technical documents, including validation protocols and reports, analytical test procedures, investigation reports and change controls.
Minimum Qualifications:
BS degree with approximately 7 years of experience or MS with approximately 3 years of experience or a PhD. Experience in the pharmaceutical industry is required.
Experience with HPLC/UPLC testing and method development
Experience with Mass spectrometry testing of small molecules (impurity ID).
Strong written and oral communication skills and the use of MS Office (Word, Excel) are required
Independent, accountable, attention to detail, ability to effectively balance multiple projects, and strong interpersonal/communication skills are required.
Must be highly motivated and self-directed
Demonstrates good interpersonal skills and works well with personnel at all levels
Authorization to work in the United States indefinitely without restriction or sponsorship
What we offer:
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
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.
To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com .
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
