Analytical Team Leader

Thermo Fisher Scientific • Teterboro, NJ

3d • $35 - $52 • Onsite

About The Position

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. 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 world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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.

Requirements

• Advanced Degree, 5-6 years of experience, or Bachelor's Degree plus 6-8 years of experience in pharmaceutical/biotech QC laboratory operations.
• Expert knowledge of GMP regulations, ICH guidelines, and pharmacopeia standards.
• Strong technical proficiency with analytical instrumentation and testing methods.
• 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.
• Excellent project management and organizational skills.
• Proficient in laboratory systems such as Empower, LIMS, TrackWise etc.
• 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.
• Demonstrated problem-solving abilities in a structured environment.

Nice To Haves

• Preferred Fields of Study: Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or related scientific field.
• Industry certifications in GMP/GDP practices beneficial.
• Experience with investigations related to OOS, OOT, Deviations, CAPA, Change Controls are preferred.

Responsibilities

• Lead a quality control team in ensuring high standards of product quality and regulatory compliance.
• Contribute to excellence in analytical testing and quality control operations.
• Work with cross-functional teams to implement quality improvements, troubleshoot technical issues, and maintain rigorous GMP standards.
• Support and develop 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.
• 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 etc.
• 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.
• Care for own safety and wellbeing.
• Promote a safe working environment for employees and contractors working in their area of responsibility.
• Support site HSE policies and ensure work performed is compliant with local HSE regulations.
• Complete all required HSE trainings.
• Report all accidents and incidents and support investigations in their areas of responsibility.
• Ensure timely closure of HSE actions owned by their departments.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level