Supervisor-Analytical Science - Military veterans preferred

Cambrex


Supervisor-Analytical Science

US-NC-Durham

Job ID: 2025-4363
Type: Regular Full-Time
# of Openings: 1
Category: Analytical
Cambrex - Durham

Overview

Our Analytical Services Department is seeking a motivated analytical scientist at the Supervisor level to
oversee a small but growing team of analytical scientists focused on supporting a wide range of clinical
to commercial Quality Control testing workflows as well as analytical development and method
onboarding workflows for drug substance and drug product.

Reporting to the (Manager, Associate Director, or Director), the Analytical Services Supervisor will
provide (with guidance from management) strategic oversight and operational direction for a team of
analytical scientists that may support either development and or quality control testing for small
molecule drug substances and drug products in a fast-paced work environment. The supervisor will be
responsible for operational project planning including resource allocation, project oversight, technical
oversight with some business level management to support ongoing or incoming projects. This role will
interact with clients and is responsible for successfully meeting client and team objectivies in a timely
manner. The supervisor will have direct responsibility over laboratory staff.

• An SME in at least 1 functional area with strong quality focus
• Overseeing and coordinating the daily prioritization of the laboratory functions for GMP and or
  non-GMP projects, including scheduling of assigned staff and equipment and lab productivity
  assessments
• Direct supervision of laboratory staff in the functional area
• Supports team to ensure proper creation of test methods, validation reports, stability protocols
  and reports, and (where required) 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,
• Must be capable and willing to provide backup assistance in performing testing and reviewing
  laboratory data included but not limited to, HPLC, GC, IC, FT-IR, KF, and dissolution. Depending
  on team size this could be up to approximately 50% of the job requirement.
• Provide scientific and quality oversight with ability to troubleshoot instruments.
• Work cross-functionally with other departments and teams as a required.
• Provides regular updates to clients and leadership on project deliverables.
• Assisting with management of critical laboratory programs such as stability and reference
  standard programs

Education

• BS, MS, or PhD in Chemistry or related scientific field.
• A minimum of 8 years (BS), 6 years (MS), or 3 years (PhD) of experience within a quality control
testing environment is required. Experience in analytical development, validations, and method
transfers is required.

Required Knowledge/ Skills/Abilities
• 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.
• Strong understanding of basic lab techniques
• Good understanding of FDA, EU and ICH requirements and implementation for GLP and GMP in
the pharmaceutical industry.
• Good analytical and problem-solving skills, with the ability to think strategically.
• Demonstrated leadership abilities to motivate staff and drive technical and quality excellence
• Exposure to phase-appropriate analytical decision making with ability to navigate method
lifecycle enhancements
• 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.
• Good time and resource management skills.
• 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.
• Ability to grow and manage a high-performance team focused on quality, accountability and
meeting and exceeding expectations

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