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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 Director of Process Support and Quality Control, the Manager, PSG is responsible for the immediate day to day operations of the in-process and raw material testing subgroup of QC. In the absence of the Director, the Manager of PSG may be responsible for supporting the operation of the PSG and QC team. The Manager of PSG will provide technical support and leadership for the laboratory staff, allocate laboratory resources to meet production timelines, and work to improve overall testing efficiency. Interaction with all areas of the manufacturing plant site will be inherent in this position.

Responsibilities

+ Serve as a department representative for internal/external clients for interdepartmental project meetings, inquiries, and facility audits.

+ Write, revise, review, or approve SOPs, analytical methods, reports, and specifications as needed.

+ Coordinate daily prioritization of in-process and raw material testing, including staff and equipment utilization, with QC Supervision and the QC Planner

+ Maintain and manage cGMP and general lab systems at defined levels of compliance.

+ Oversee the assignment of QC resources and monitor the daily progress relative to communicated production needs.

+ Utilize and develop metrics to decrease sample throughput time in PSG.

+ Review and approve methodology and technical reports for clarity and accuracy.

+ Draft and review various documents in support of laboratory efforts and production campaigns.

+ Own critical laboratory investigations for critical process PRs that may impact regulatory or commercial items.

+ Oversee and track weekly production and shipping needs.

+ Working with the Director, monitor immediate project scopes for the current fiscal quarter to ensure the active or scheduled campaigns have the required materials required for laboratory support.

+ Verify monthly deliverables (including SAP billing) are completed on time and are accurate.

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications/Skills

+ Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases preferably in a Windows environment

Education, Experience & Licensing Requirements

+ Bachelor's Degree in Chemistry, Pharmacy or closely related field required. Advanced degree highly beneficial.

+ 7 or more years of experience in manufacturing support laboratory in the pharmaceutical industry, preferably API and/or intermediate experience, with at least 3+ years in management or supervisory role in the pharma industry.

+ Hands on experience with pharmaceutical laboratory management required. Management of 24/7 lab operation highly beneficial.

+ Familiarity with compliance requirements within cGMP, safety and regulatory environments

+ Operational knowledge of analytical instrumentation like HPLC/UPLC, GC, IC. ICP, FTIR, UV-VIS equipment, and data stations required

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.

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