Analytical Development Manager

Thermo Fisher Scientific Inc.; Warrington; On-site; GBP 50,000 - 75,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a manager to oversee analytical development scientists. The role involves providing analytical support for drug development and leading projects for the introduction of new products. Key responsibilities include ensuring compliance with GMP standards, coordinating with various teams, and developing team capabilities within the Analytical Development group.

Responsibilities

• Oversee AD scientists for method development and optimization.
• Provide analytical expertise for drug development.
• Lead analytical projects for new products.

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)

Job Description

To oversee a team of AD scientists for method development/optimization, validation, transfer, daily/weekly planning, and execution of experiments.

To provide analytical expertise and technical support for all phases of drug development to support the introduction of new products, process development, plant investigations, and regulatory activities.

To lead analytical projects for the introduction of new products to the site, including method assessment, development, validation/qualification, and transfer.

To provide lead technical and analytical support to the team for resolving operational, technical, and analytical issues within the Analytical Development (AD) laboratory.

To promote and supervise laboratory GMP/safety within the AD group, ensuring the laboratory remains inspection-ready.

To coordinate with clients, project management, manufacturing, QC, and PDS teams, sharing periodic updates on assigned projects.

To actively participate in developing the AD group as a center of excellence.

To participate in capability building and drive competency development within the AD group.

To create schedules for team members and provide performance feedback.

To motivate the team to perform their duties timely and efficiently.

To participate in regulatory and customer audits.

To support the AD manager in budgeting and recruitment.

Laboratory GMP Compliance

• Obtain a working knowledge of all relevant site and analytical SOPs.
• Maintain laboratory notebooks and testing sheets in compliance with GMP requirements.
• Carry out calibration of equipment and analytical balances as required.
• Ensure validation/calibration documentation for instrumentation is signed off before use.
• Maintain good housekeeping standards, conduct audits, and complete assigned actions promptly.
• Participate in internal and external audits as required.
• Maintain ongoing individual training records.
• Participate in training team members as appropriate.
• Archive all data properly.

Technical Support or Troubleshooting for Existing Products

• Provide technical data and opinions to internal and external customers as needed.
• Participate in cross-functional meetings and teleconferences.
• Participate in deviation investigations as required.