Senior Scientist - HPLC , UPLC at Thermo Fisher Scientific in Summit, New Jersey

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)



Job Description



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.


Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.



Key responsibilities:



As a Senior Scientist you will develop, 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 Associate 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.

• 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, FT-IR, Karl Fischer titrations, etc.


• Transfers validated methods to customer labs 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 / worksheets 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.


• Follows Environmental Health and Safety Requirements


• Other duties as assigned by supervisor.

Education and Experience:

• 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')


• 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:

• Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.)


• Familiar with dissolution, KF, FT-IR, UV/VIS spectrophotometry, titrations, etc.


• Experience in laboratory investigation and documentation of Out-of-Specification results.


• 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.

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! Apply Now