Work Schedule
First Shift (Days)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Will work with hazardous/toxic materials

Job Description

DESCRIPTION:

Lead a quality control team in ensuring high standards of product quality and regulatory compliance at Thermo Fisher Scientific. As Team Leader, QC, you'll 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 Bachelor's 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.

HSE

• 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
The hourly pay range estimated for this position based in New Jersey is $34.61-$51.92.

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: https://jobs.thermofisher.com/global/en/total-rewards