Cambrex ยท 5 days ago
Manager Quality Control (Stability and Reference Standard Focus)
High Point, NC
Full-time
Onsite
Senior Level
7+ years expCambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. The Manager of Quality Control will oversee and direct the QC scientific staff, focusing on analytical support for stability and reference standard programs while ensuring compliance with regulatory guidelines.
AnalyticsBiotechnologyInnovation ManagementManufacturingMarket ResearchPharmaceutical
Hiring Manager
Rob Duncan
Responsibilities
Manage/coordinate/drive efforts of staff in stability plan design and coordinating the activities that support the entire stability lifecycle of the study
Manage/coordinate/drive efforts of staff in the design of stability protocols and reports in accordance with ICH guidelines and publishing in MasterControl with adherence to associated SOPs
Manage/coordinate stability study set down to fraction and stage materials
Track/monitor all active stability programs including pull dates and report issue dates
Ensure stability inventory is correct and up to date
Manage/coordinate/drive efforts for reference standard management and retesting program
Track/monitor all current reference standards to plan for the testing and timely delivery of certificates
Provide training/development for specified laboratory staff on the stability and reference standard program
Routinely represents the department on stability and reference standard topics in internal or external meetings, with clients, and during audits
Assure compliant, staffed analytical laboratory support
Write deviations, assist/lead laboratory investigations, and assist in CAPAs relative to stability and reference standard program
Recommend/justify new/additional equipment, staffing or organizational positions, promotions
Qualification
Required
Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills
Track record of successfully applying high level judgment in a variety of complex and unprecedented situations
Proven ability to act independently to achieve pre-determined goals and objectives and obtain desired results
Ability to coach and develop staff and to transfer job knowledge and skills
Ability to integrate input/data from diverse sources and create new and innovative solutions
Demonstrated ability to apply technical, functional, and industry knowledge to design and execute projects that shape the strategic direction of one or more projects
Other demonstrated abilities: work in a diverse team environment; foresight and judgment in planning, organizing, and guiding complex projects; making complex decisions and troubleshooting in ambiguous situations
Exposure to broader analytical techniques (i.e., beyond just USP compendial testing)
BS, MS, or PhD in Chemistry (or closely related discipline)
A minimum of at least 7 plus years' experience in QC (or similar role) with 2 plus years' experience managing others in a laboratory environment (prefer in a GMP/QC-compliant pharmaceutical laboratory environment) with focus on ICH stability testing
Strong Quality Control, compliance, scheduling, and organizational skills and insight
Expertise in most common analytical techniques/technologies (e.g., HPLC, GC, LC/GC/MS, IR, Empower, etc)
Expertise in USP compendial and other technical application testing and in OOS investigations
Expertise in creating and interpreting SOPs
Ability to function as technical expert/consultant
Benefits
Medical
Dental
Vision
Life
LTD
Generous vacation in your first year
Sick time
Retirement savings
Company
Cambrex
Cambrex is a small molecule company that offers drug substance, drug product, and analytical services.
1001-5000 employees
H1B Sponsorship
Cambrex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (19)
2023 (16)
2022 (15)
2021 (7)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
unknown2019-08-07Acquired
1987-10-02IPO
Leadership Team
Tom Loewald
Chief Executive Officer
Robert Green
EVP & Chief Financial Officer
Recent News
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