Assoc Research Scientist – qNMR, HPLC, KF

ThermoFisher Scientific; Boston (MA); On-site; USD 110,000 - 115,000; Full time

Job summary

Thermo Fisher Scientific in Boston, MA is seeking an Assoc Research Scientist to lead early process development analytics, including qNMR, HPLC, and KF, within a GMP framework. This full-time onsite role requires passing a background check.

You will collaborate with contract labs, design IPC methods, and present findings to cross-functional teams while meeting timelines. A bachelor’s or higher in a lab science with 6+ years or a master/PhD with relevant experience is required.

Qualifications

• Excellent verbal and written communication skills are essential.
• Experience and/or working knowledge of control strategy development.
• Good understanding of cGMP, ICH, FDA, and USP guidelines, including ICH guidelines on the control of impurities (organic, residual solvents, and elemental, DNA reactive (including ICH M7 option 4 / in silico control), and nitrosamines)
• Skilled in modern analyses for small molecule pharmaceuticals, particularly chromatography (HPLC/UPLC), KF, qNMR etc.
• The ability to work successfully in both a team/matrix environment as well as independently
• The ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects

Responsibilities

• Early Process Development
• Collaboratively design and oversee drug substance process development analytical activities for early phase development.
• Identify critical in-process-control issues and develop appropriate IPC methods
• Serve as the subject matter expert for drug substance analytical development with contract manufacturing and testing labs
• Develop analytical methods, suitable early-stage pharmaceutical development
• Understand chemical development and solid-state development to identify and document critical factors that impact quality, method performance, or associated analytical development activities
• Present to cross functional teams and effectively communicate critical analytical issues and solutions

Skills

Verbal and written communication

Control strategy development

cGMP/ICH/FDA guidelines

Chromatography (HPLC/UPLC)

qNMR

Teamwork and independence

Education

Bachelor's degree in lab sciences

ARS: 6+ years experience

Masters degree: 4+ years

PhD: 2+ years

Tools

HPLC/UPLC

KF

qNMR

Job description

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Assoc Research Scientist – qNMR, HPLC, KF

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:

• Early Process Development
• Collaboratively design and oversee drug substance process development analytical activities for early phase development.
• Identify critical in-process-control issues and develop appropriate IPC methods
• Serve as the subject matter expert for drug substance analytical development with contract manufacturing and testing labs
• Develop analytical methods, suitable early-stage pharmaceutical development
• Understand chemical development and solid-state development to identify and document critical factors that impact quality, method performance, or associated analytical development activities
• Present to cross functional teams and effectively communicate critical analytical issues and solutions

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• ARS: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’)
• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years’)

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:

• Excellent verbal and written communication skills are essential
• Experience and/or working knowledge of control strategy development.
• Good understanding of cGMP, ICH, FDA, and USP guidelines, including ICH guidelines on the control of impurities (organic, residual solvents, and elemental, DNA reactive (including ICH M7 option 4 / in silico control), and nitrosamines)
• Skilled in modern analyses for small molecule pharmaceuticals, particularly chromatography (HPLC/UPLC), KF, qNMR etc.
• The ability to work successfully in both a team/matrix environment as well as independently
• The ability to work in a fast-paced environment, manage priorities, communicate outcomes and maintain timelines for multiple projects

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 $110,000.00–$115,100.00.

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.