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Manager, Quality Control

Location

Durham, NC, USA

Department

Quality Control

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

Our Analytical Services Department is seeking a motivated analytical scientist and manager to oversee a rapidly growing core-team of analytical scientists focused on supporting a wide range of late phase and commercial Quality Control testing workflows for drug substance and drug product. This role is focused in small molecule testing services with a priority for release and stability testing but may also support the reference standard programs and method validations as needed.  The person’s primary responsibilities will include overseeing and planning resourcing across this Analytical team, scheduling project workflows, and ensuring on-time first-time write QC testing for programs that have achieved steady-state operations. The leader will work closely with earlier clinical phase core-teams to ensure a seamless transfer of knowledge.

This role will interact with clients and is responsible for successfully meeting client and departmental objectives in a timely manner.

Responsibilities

  • Lead a QC-oriented core-team of highly cross-trained scientists supporting release and stability programs for clients in late phase and commercial
  • Represents the department in meetings, collaborates and cooperates to achieve cross-functional improvements and business goals
  • Supports creations of departmental systems and fosters a culture of continuous improvement focused on value to the customer
  • Supports team to ensure proper creation of test methods, validation reports, stability protocols and reports, and development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by HPLC/UPLC (PDA/VWD/CAD/ELSD/RID/FLD/MSD), FT-IR, GC-FID/MS, cKF, ROI, Dissolution, etc,
  • Manages the day to day operations for assigned area.
  • Works closely with our trainers to ensure all staff members are fully trained.
  • Participates in and supports client visits, audits and inquiries to ensure complete fulfilment of requests and interests.
  • Supports Recruitment, trains, develops and retains staff for the effective process of departmental operations.
  • Provides technical guidance for troubleshooting and investigating simple to complex issues in area of expertise.
  • Applies statistical analysis for interpretation of project data.
  • Ensures all cGxP data generated for projects are managed and evaluated as described in relevant internal procedures and regulatory requirements.
  • Effectively resolves quality issues and concerns in a timely manner.
  • Creates strong and effective relationships with clients.

Qualifications

Education & Experience

A BS, MS, or PhD with at least 5 years laboratory experience in a QC environment and 3+ years management experience is preferred with a focus in QC/stability testing for small molecules.

Required Knowledge/ Skills/Abilities

Knowledge

  • Strong technical skills for area managing
  • Good business acumen
  • Strong understanding of company SOPs, and regulatory guidance documents.
  • Strong knowledge of safety procedures and quality compliance for assigned area
  • Strong knowledge of cGMP requirements.
  • Experience with client audits is a plus.
  • Strong understanding of basic lab techniques
  • Strong knowledge of FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
  • If applicable, experience with compliance for API and drug product and/or drug substance.
  • Experience with regulatory agency inspections of GXP facilities.
  • Experience working with CDMOs.

Skills / Abilities:

  • Excellent analytical and problem-solving skills, with the ability to think strategically.
  • Strong understanding of applicable GMP/ICH requirements
  • Passionate about quality of work while remaining an inclusive team member, and technical driver
  • Preference to those that demonstrate a winning attitude, cultural driver, great organizational skills, and attention to detail
  • Strong attention to detail, as well as time and resource management.
  • Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
  • Promote a safe environment for work.
  • Comply with the general policy of the company.
  • High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
  • Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.
  • Professional Skill Qualifications:
  • Flexible mindset to be able to learn and troubleshoot new techniques
  • Must be able to schedule time and be organized
  • Must have strong operational knowledge of instrumentation used to test small molecule pharmaceuticals including drug substances and drug product
  • Ability to handle multiple priorities and projects concurrently
  • Demonstrated accountability with prior positions
  • Ability to adhere to a strict attendance policy
    • Excellent verbal and written communication and analytical skill with a strong attention to detail