Company Information You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
The Stability Coordinator, reporting to the QC Manager, will be responsible for maintaining the stability program of Cambrex High Point (CHP) customer products. This role will ensure the stability program meets the expectations of all regulatory agencies and remains compliant with applicable Company SOPs and regulatory guidance's. This position will be required to work well with cross functional teams and will be the key point of contact for the CHP stability program.
Responsibilities Maintaining a compliant stability program meeting client needs and expectations. Write stability protocols, protocol change forms, interpreting stability trend results and writing Perform stability staging and document in laboratory notebook. Maintain inventory of stability staging supplies and reorder as needed. Ship samples for outside testing and post results for review. Monitoring and maintaining chambers (may involve on-call). Work closely with QC, data review and QA colleagues to ensure timelines are met and reports are accurate. Interaction with clients for review of stability documents and addressing client questions. Oversee reference standard program. This position works with and handles hazardous materials and waste at Cambrex. Must have the appropriate qualifications to read, understand, apply and communicate written and verbal information regarding handling and managing hazardous wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes .
Qualifications/Skills
Experience with and fundamental understanding of several of the following analytical technologies
(* - most important):
HPLC* (Empower preferred) XRPD cKF Working knowledge of other analytical equipment common to the pharmaceutical industry.
Advanced computer knowledge including word processing, spreadsheets, and database management.
Experience with management of or working knowledge of stability programs.
Education, Experience & Licensing Requirements
BS or MS in Chemistry (or closely related discipline). Strong comprehension and facility in quantitative/qualitative analytical Chemistry. A minimum of at least 4-6 years of strongly relevant background in GMP/QC-compliant analytical testing in a pharmaceutical laboratory environment.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
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