Analytical Team Leader

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

As Team Leader QC youll contribute to excellence in analytical testing and quality control operations while supporting our mission to enable customers to make the world healthier cleaner and safer. Work with cross-functional teams to implement quality improvements troubleshoot technical issues and maintain rigorous GMP standards. Support and develop your team members while ensuring efficient lab operations timely completion of testing and meticulous documentation of results. Interface with clients and regulatory bodies as a subject matter expert in your area of focus.

EDUCATION:

Advanced Degree 5-6 years of experience or Bachelors Degree plus 6-8 years of experience in pharmaceutical/biotech QC laboratory operations.
Preferred Fields of Study: Chemistry Biology Biotechnology Pharmaceutical Sciences or related scientific field.

Industry certifications in GMP/GDP practices beneficial.

REQUIREMENTS:

Participate in investigations related to OOS OOT Deviations CAPA Change Controls experience w/these protocols are preferred.
Expert knowledge of GMP regulations ICH guidelines and pharmacopeia standards.
Strong technical proficiency with analytical instrumentation and testing methods.

Lead analytical method transfer activities from R&D contract laboratories or external manufacturing sites to the QC laboratory.

Prepare and review method transfer protocols reports and supporting documentation.

Coordinate transfer execution comparative testing and acceptance criteria evaluation.

Ensure successful implementation of methods including Assay Related Substances/Impurities Dissolution Content Uniformity Residual Solvents Cleaning Methods CCIT Osmolality etc.

Experience in qualification and analytical methodology of laboratory instruments including HPLC/UPLC LC-MS GC-MS IC ICPMS UV FTIR pH Meters Osmometers Rheometers etc.
Experience with laboratory information management systems (LIMS) and quality system documentation.
Ensure timely testing of raw materials in-process samples stability samples cleaning validation samples and finished products.
Excellent project management and organizational skills

Proficient in laboratory systems such as Empower LIMS TrackWise etc.

Ensure analysts are trained and qualified on analytical techniques and laboratory systems.

Ensure compliance with SOPs specifications analytical procedures and GMP requirements
Strong interpersonal abilities to lead teams and collaborate across functions.
Clear written and verbal communication skills including technical writing
Proficiency with Microsoft Office suite and statistical analysis tools
Ability to work various schedules to support project needs.
Strong attention to detail and commitment to data integrity. Ensure compliance with cGMP GLP data integrity (ALCOA) and regulatory requirements.
Experience managing lab equipment calibration and maintenance programs. Troubleshoot analytical methods and resolve technical issues during transfer activities.
Knowledge of environmental monitoring and contamination control.
Demonstrated problem-solving abilities in a structured environment.

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.
• The individual must support site HSE policies as well as ensure that work performed is compliant with local HSE regulations.
• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Manager