Senior QC Chemist

Thermo Fisher Scientific Inc.; Boston (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player seeks a Senior Chemist to deliver world-class analytical solutions in a dynamic laboratory environment. You will play a vital role in ensuring quality control operations meet regulatory compliance and data integrity principles. This position involves collaborating with cross-functional teams, managing laboratory operations, and leading investigations to uphold the highest standards of quality. If you have a passion for chemistry and a commitment to excellence, this opportunity offers a chance to make a significant impact in the pharmaceutical industry.

Qualifications

• 7+ years in pharmaceutical or medical devices, focusing on Quality Control.
• Extensive knowledge of regulatory expectations including FDA and EMA.

Responsibilities

• Support new equipment qualification and lab setup.
• Lead testing process for raw materials and drug substances.
• Train fellow chemists and act as a Subject Matter Expert.

Skills

Analytical Chemistry

Quality Control (QC)

HPLC

Regulatory Compliance

Interpersonal Skills

Problem-solving

Education

University degree in Chemistry

Equivalent experience in Life Sciences

Tools

HPLC

UPLC

CE

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

Position Summary

As a Senior Chemist, you will play a vital role in delivering world-class analytical solutions through outstanding expertise in biologic chemistry. Your work will significantly impact our ambitious projects, ensuring flawless quality control operations that meet regulatory compliance and data integrity principles. You will collaborate closely with other functions, promoting a proactive business partnership to successfully implement method qualifications and validation strategies.

Responsibilities

• Support new equipment qualification, lab computerized systems, and chemistry lab setup.
• Perform transfer, verification, and validation of laboratory procedures.
• Prepare technical documentation, including protocols, analytical write-ups, standard operating procedures, specifications, investigations, and reports.
• Analyze incoming goods, intermediates, and finished products under cGMP conditions for QC release and stability studies.
• Lead the testing process from sampling to the release of raw materials, drug substances, process aids, and packaging materials.
• Ensure timely and compliant testing of all chemistry-related analyses, including HPLC, GC, and stability analysis.
• Manage daily laboratory operations, ensuring compliance with GMP standards.
• Identify and address compliance gaps with updated pharmacopoeia and regulations.
• Lead laboratory investigations, deviations, and ensure timely closure in line with quality management systems.
• Review analytical and laboratory data for accuracy and compliance.
• Perform maintenance and calibrations on laboratory equipment.
• Troubleshoot technical issues related to analytical equipment and methods.
• Manage QC chemical, reference standard, and consumable stock levels.
• Train fellow chemists, serving as a mentor and expert.
• Maintain a detailed understanding of international regulatory requirements.
• Communicate effectively with cross-functional teams and participate in problem-solving activities.
• Act as a Subject Matter Expert during audits and inspections.
• Undertake internal audits and support continuous improvement initiatives.
• Promote a culture of quality and adherence to cGMP, EHS, and 5S standards.
• Be prepared to support shift work if needed.

Minimum Requirements/Qualifications

Education:

• University degree or equivalent experience in chemistry, biochemistry, or life sciences.

Experience:

• At least 7 years of proven experience in the pharmaceutical or medical devices industry, with a focus on Quality Control.
• Extensive knowledge of regulatory expectations including PICS, ICH, Singapore HSA, EMA, and US FDA.

Proficiencies:

• Knowledge and exposure to cGMP environment.
• Sound technical knowledge of QC chemistry techniques (HPLC, UPLC, CE, etc.).
• Strong interpersonal and communication skills in English.
• Ability to work cross-functionally and meet timelines and objectives.
• Experience with Health Agency/internal audits.