Senior Scientist – Quality Control

ThermoFisher Scientific; Boston (MA); In loco; USD 95.000 - 100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) plan

Paid time off

Tuition reimbursement

Employee stock purchase plan

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Sr. Scientist – Quality Control in Boston, MA for a full-time on-site role. The position requires strong cGMP knowledge, extensive laboratory methods experience, and the ability to lead in-process and release testing.

Responsibilities include method validations, data review, and maintaining compliant records, with a focus on accuracy and continuous improvement within a GMP environment. Competitive benefits and relocation not provided.

Competenze

• Bachelor degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar.
• Sr. Scientist: 4+ years of experience comparable to the role.
• Master's degree plus experience comparable to 2+ years, or PhD.
• Equivalency may be considered based on education and experience.

Mansioni

• Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs.
• Maintain accurate testing records and adhere to cGMP/GDP expectations.
• May participate in executing method validations and/or method transfers.
• Assist in troubleshooting of analytical methods with manager support.
• Participate in authoring and reviewing data, SOPs, methods, protocols and reports.
• Participate in compliance-related teams for continuous improvement.
• Report OOT/OOS results and other deviations to area management.
• Perform other laboratory duties as assigned.

Conoscenze

cGMP concepts

Laboratory techniques

Communication skills

Formazione

Bachelor in science

Sr. Scientist 4+ years

Masters degree

PhD

Strumenti

HPLC

GC

KF

Dissolution

TOC

UV

IR

pH meter

Balance

Descrizione del lavoro

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting

Job Description

Sr. Scientist – Quality Control

Shift: Full-Time; Monday – Friday; 8am-5pm EST

ONSITE:

This is a fully onsite role based at our customer’s site in Boston, MA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States withoutsponsorship.

Must be able to pass a comprehensive background check, whichincludes a drug screening.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.

Key responsibilities:

• Perform in-process, release, and stability testing and/or review independently following established methodology, procedures and SOPs
• Maintain accurate testing records and adhere to cGMP/GDP expectations
• May participate in executing method validations and/or method transfers
• Assist in troubleshooting of analytical methods with the assistance of manager when necessary
• May participates in author and review of data, SOPs, analytical methods, protocols and reports
• May participate in compliance related teams working towards the goal of continuous improvement.
• Report OOT/OOS results and other deviations to area management.
• Perform other laboratory duties as assigned.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• OR PhD

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Understands cGMP concepts and general practices - MUST HAVE
• Knowledge of various complex laboratory equipment including HPLC, GC, KF, dissolution, TOC, UV, IR, pH meter, and balance
• Knowledge and experience in chromatography, dissolution, and Karl Fisher
• Strong attention to detail
• Demonstrate good communication skills both oral and written.
• A minimum of a Bachelor Degree in science or related discipline is required.
• Typically requires 4 years of experience in GMP pharmaceutical/biopharmaceutical industry

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $95,000.00–$100,100.00.

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.