Lab Group Leader

2 weeks ago

Ware, United Kingdom Thermo Fisher Scientific Full time

**Group Leader - Ware, UK**

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our clients to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Summarized Purpose:
Provides line-level management coordination of resources and work schedules for laboratory activities. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed. Ensures that laboratory staff continues to be developed to keep pace with department goals and growth. This position may also be working part of the time in the lab using HPLC, KF, Dissolution, etc for the testing of small molecule compounds in a GMP lab setting.

Essential Functions:

- Performs lab work in accordance with client protocols, methods and requirements. HPLC, KF, Dissolution, etc. in a GMP Lab setting.
- Assists in preparation and implementation of study protocols, project status reports, final study reports and other project-related technical documentation.
- Designs experimental study and participates in technical troubleshooting.
- Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs. Reviews laboratory investigations and deviations.
- Organizes, schedules and supervises laboratory resources for group's project activities and updates project status.
- Responds to client questions and needs, coordinates client communication and records meeting minutes.
- Assists laboratory manager in their responsibilities.
- Assists in preparation and implementation of PPD/client SOPs and company operational policies. Ensures adherence to SOPs, safety standards and company policies.

Education and Experience:

- Bachelor Degree in Chemistry, Organic Chemistry, Chemical Engineering, Pharmaceutical Science or similar
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.
- 1+ year of leadership responsibility

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

- Demonstrated proficiency on technical operating systems
- At least one year of experience in a Regulated GMP Lab is required.
- Demonstrated ability to perform lab work for HPLC, KF, Dissolution, etc. in a GMP Lab setting.
- Demonstrated ability to perform/understand method validation for small molecule projects
- Proven leadership skills
- Ability to train and mentor junior staff
- Demonstrated ability to be project solution driven
- Good written and oral communication skills as well as presentation skills
- Can independently perform root cause analysis for method investigations
- Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)
- Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to SOPs
- Ability to independently optimize analytical methods
- Project and time management skills

**Our 4i Values**:
Integrity - Innovation - Intensity - Involvement

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