Sr Scientist, GMP Analytical Testing

Thermo Fisher Scientific • New Brunswick, NJ

2d • Onsite

About The Position

Join us as Senior Scientist! This is a fully onsite role based at our customer’s site in New Brunswick, NJ. 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 without sponsorship. Must be able to pass a comprehensive background check, which includes 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. The Senior Scientist will validate and implement analytical methods to assess physical and chemical properties of pharmaceutical materials. This work is conducted in a highly-collaborative, multi-disciplinary team charged with the overall research & development of our active ingredients, formulated products, and the associated manufacturing processes. The Senior Scientist plays an important but supporting role throughout the development of new drug candidates from discovery to commercialization, contributing to the advancement of new therapeutics.

Requirements

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar and Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)
• Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• PhD
• Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.)
• Familiar with dissolution, KF, titrations, etc.
• Experience in laboratory investigation and documentation of Out-of-Specification results.
• 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.

Nice To Haves

• Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables) is a plus.

Responsibilities

• Contributes to the development of priority drug candidates through the development, validation, and implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, Karl Fischer titrations, etc.
• Transfers validated methods to customer labs, including BMS and partner-owned quality control (QC) labs.
• Performs testing for development and clinical materials and stability samples in accordance with established methods, specifications and protocols under supervision.
• Knows the fundamentals of analytical methodology and can troubleshoot instrumentation and method performance issues of routine complexity.
• Documents / reviews laboratory work using laboratory notebooks /electronic notebooks that is detailed, timely and in compliance with GLP / GMP requirements.
• Contributes data to the preparation of high-quality technical reports as source documents for regulatory submissions.
• Reviews data for compliance and adherence to specifications and acceptance criteria.
• Communicates results according to project timelines and works with collaborators to understand project needs and contribute to overall analytical control strategy. Draws basic conclusions from data and results.
• May be responsible for coordination of method transfers, testing, management of and acceptance of data acquired by contract laboratories & service providers.
• Prepares and/or reviews testing protocols and reports.
• Operates within and maintains the laboratory in an ‘audit ready’ status.
• Complies with Environmental Health and Safety Requirements
• Other duties as assigned by supervisor.

Benefits

• competitive remuneration
• annual incentive plan bonus
• healthcare
• 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
• short- and long-term disability
• 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: Senior