Job Description
Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
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
Reporting to the Manager, QC, the QC Supervisor willprovidesupervisoryoversight, laboratory testing support,and technical leadership forLaboratory staff. The QC Supervisor willbe responsible fordirecting the laboratory workflow for daily testingofisolated intermediates, finished goods, andstabilityand providing on-going support for these activities.
Responsibilities
- Coordinate daily prioritization of QC testing, including staff and equipmentutilization.
- Maintain laboratory instrumentation, including equipment qualification,andpreventative maintenanceprograms. May need toassistwith troubleshooting and minor repairs.
- Support training and troubleshooting efforts for staff.
- As necessary, review completed laboratory testing to support thetimelyrelease of data,reports, and material.
- Coordinate and oversee the status of offsite sample testing.
- Maintain and manage cGMP and general lab systems at defined levels of compliance.
- Draft and review various documents in support of laboratory efforts and production campaigns.
- Maintain laboratory systems and documentation.
- Ona rotatingcoverage, providelaboratory on-call support coverageforall aspects of laboratory operation, includingenvironmentaltesting, raw materialtesting, in-processtesting,isolated intermediate testing,andfinishedgood productrelease.
- Work cross-functionally with other departments (such as Operations/Production) to ensure deliverables are met according to projected timelines.
- Verify timecards and SAP billing is completed accurately and on time as per thesite-specifictimelines.
- Perform the QC release for raw materials, isolated intermediates, and finished goods.
- Identifydiscrepancies,authorout of specification and deviation investigations withinTrackWise,and implement associated CAPAs.
Qualifications/Skills
- Familiarity with compliance requirements within cGMP,safetyand regulatory environments
- Operational knowledge of analytical instrumentation like HPLC/UPLC, GC,IC. ICP, FTIR, UV-VIS equipment, and data stationsrequired
- Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment
- Strong chemistry knowledge
Education, Experience & Licensing Requirements
- Bachelor's Degree in Chemistry, Pharmacy or closely related fieldrequired. Advanceddegreehighly beneficial.
- 5or more years of experience in manufacturing support laboratory in the pharmaceutical industry, preferably API and/or intermediate experience.
- Handsonexperience with pharmaceutical laboratory managementrequired. Management of 24/7 lab operation highly beneficial
_Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration._
_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._
