Analytical Team Leader

As part of the Thermo Fisher Scientific team, you’ll 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.

About the role

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.

Responsibilities

• Participate in investigations related to OOS, OOT, Deviations, CAPA, Change Controls
• 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
• Experience in qualification and analytical methodology of laboratory instruments including HPLC/UPLC, LC-MS, GC-MS, IC, ICPMS, UV, FTIR, pH Meters, Osmometers, Rheometers
• Ensure timely testing of raw materials, in-process samples, stability samples, cleaning validation samples, and finished products
• Ensure analysts are trained and qualified on analytical techniques and laboratory systems
• Ensure compliance with SOPs, specifications, analytical procedures, and GMP requirements
• Manage lab equipment, calibration, and maintenance programs
• Troubleshoot analytical methods and resolve technical issues during transfer activities
• Support site HSE policies and ensure compliance with local HSE regulations; complete all required HSE trainings; report accidents and incidents; ensure timely closure of HSE actions

Requirements

• 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
• Expert knowledge of GMP regulations, ICH guidelines, and pharmacopeia standards
• Strong technical proficiency with analytical instrumentation and testing methods
• Experience with laboratory information management systems (LIMS) and quality system documentation
• Proficient in laboratory systems such as Empower, LIMS, TrackWise
• 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
• Strong attention to detail and commitment to data integrity
• Ensure compliance with cGMP, GLP, data integrity (ALCOA+), and regulatory requirements
• Knowledge of environmental monitoring and contamination control
• Demonstrated problem-solving abilities in a structured environment

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) Safety Standards
• Laboratory setting
• Office environment
• Will work with hazardous/toxic materials

Schedule

First Shift (Days)

Pay

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.

Benefits

• 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