Manager, Analytical Services in Durham, North Carolina at Cambrex

Our Analytical Services Department is seeking a motivated analytical scientist at the Manager level to oversee a growing team of analytical scientists focused on supporting a wide range of clinical to commercial Quality Control and Analytical Development workflows for drug substance and drug product.

Reporting to the Associate Director, the Analytical Services Manager will provide overall strategic oversight and operational direction for a highly cross-trained team of analytical scientists simultaneously supporting both development and quality control testing for small molecule drug substances and drug products in a fast-paced work environment. The Manager will be responsible for operational project planning including resource allocation, technical project oversight, quality oversight, and business level management to support ongoing or incoming projects. This role will interact with clients and is responsible for successfully meeting client and departmental objectives in a timely manner. The Manager will have direct responsibility over laboratory and non-laboratory(technical review) support staff.

QuantitativeLCMSMS Experience Required

• An SME in more than one functional area with ability to drive client program success through team leadership across areas of support.
• Overseeing and coordinating the daily prioritization of the laboratory functions for GMP and non-GMP projects, including scheduling of assigned staff and equipment and lab productivity assessments
• Strong ability to develop and validate analytical methods, and rapidly troubleshoot issues that arise during analytical development
• Direct supervision of laboratory staff in the functional area and non-laboratory staff (technical reviewer(s)). Providing feedback and evaluations as needed and required.
• 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.
• Ability to identify and or hire top talent and foster talent growth within the team.
• Must be capable of providing backup assistance in performing testing and reviewing laboratory data included but not limited to, HPLC, GC, IC, FT-IR, KF, and dissolution.
• Provide scientific and quality oversight with ability to troubleshoot instruments.
• Work cross-functionally with other departments and teams as a required.
• Drives continuous improvement in quality and technical culture within team.
• Provides regular detailed updates to clients on project deliverables, with increasing responsibility to represent the sites quality and technical culture to clients.
• Assisting with management of critical laboratory programs such as stability and reference standard programs

Essential Job Requirements

• 2+ years of previous management experience in a quality laboratory environment required.
• Strong analytical chemistry knowledge with ability to assess CQA gaps in DS and DP control strategies
• cGMP knowledge with experience in RCA
• Strong familiarity with instrument operation and troubleshooting
• Participates in and supports Lean 6S principles and implementation of Lean Labs
• Must be able to identify discrepancies, author out of specification and deviation investigations, and support CAPAs within functional area.
• Experience supporting manufacturing operations is highly beneficial.

Required Knowledge/ Skills/Abilities Knowledge

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.
• Strong understanding of advanced lab techniques
• Good understanding of FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
Skills / Abilities:
• Excellent analytical and problem-solving skills, with the ability to think strategically.
• Experience implementing 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.

BS, MS, or PhD in Chemistry or related scientific field.
• 2+ years of direct management experience
• A minimum of 12 years (BS), 10 years (MS), or 4 years (PhD) of experience within a quality control testing environment is required. Experience in analytical development, validations, and method transfers is required.