Manager Quality Control (Stability and Reference Standard Focus)

Job Description

Company Information

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 over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

At Cambrex, our people set us apart. We’re committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

Job Overview

Come join our QC team of experts. This role will manage and direct Quality Control scientific staff. Focus efforts of self and team on analytical support with analytical activities involving the stability and reference standard programs. Enhance efficiency of current systems. Mentor and develop team members. Seek innovative cost and scientific solutions. Ensure compliance with applicable Company SOPs and regulatory guidelines.

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.

Qualifications/Skills

Excellent verbal and written communication and interpersonal skills, problem-solving, and organizational skills.

Education, Experience & Licensing Requirements

• 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 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.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is performed in an office setting and involves sitting most of the time. Walking and standing are required only occasionally. Knowledge of working with hazardous chemicals.

Position also requires visual acuity, talking, writing, and typing.