Job Description

*Work Schedule* Standard (Mon-Fri)*Environmental Conditions* Adherence to all Good Manufacturing Practices (GMP) Safety Standards*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. A versatile, pharmaceutical product development GMP laboratory seeks a hardworking, results-focused analytical chemist to support biologics pharmaceutical manufacturing. The position will require relevant expertise in chromatographic, spectroscopic (vibrational and UV), compendial, and physical testing of raw materials and excipients used in the manufacturing and formulation of biologic drug substances and drug products. This position will be located in New Brunswick, NJ, reporting directly to a Senior Scientist within the GxP Raw Materials Group of the Analytical Strategy & Operations (ASO) department. Key responsibilities:

• Demonstrate knowledge of analytical techniques contributing to the development of robust and reproducible analytical methods used in a GMP testing laboratory.
• Support the development of analytical test methods for raw materials through feasibility/assessment testing, study design, and the execution and authoring of protocols and reports.
• Independently complete analytical method qualifications, validations, and transfers (when applicable) of raw material test methods to QC laboratories, carefully adhering to protocols.
• Independently perform analytical testing including but not limited to HPLC, vibrational (FTIR, NIR, Raman) and UV spectroscopic methods, Titration assays, pH and Osmolality measurements, compendial methods and general wet chemistry techniques, and general physical description tests (color & appearance). Executed tests support clinical release and stability testing of drug substances, drug products, excipients and raw materials used in the manufacturing and formulation of clinical biologics drug substances and drug products.
• Maintain accurate and GMP-compliant documentation for experiments.
• Proactively provide clear, timely communication of potential issues to management.
• Coordinate and present data for internal meetings involving relevant technical and scientific work and issues.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• one to two (1-2) years of analytical laboratory experience in a Quality Control (QC) and GMP environment is preferred.
• OR Master’s degree

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:

• Familiarity with ICH and compendial procedures and guidelines is preferred as is an understanding of cGMP/GLP and GDP practices and EHS requirements. The ability to follow all applicable SOPs and regulatory requirements is a must and crucial for success in this position.
• Must be able to deliver when working under assigned timelines and demonstrate good time management and communication skills, particularly in documentation of data and writing reports and methods. Skill in communicating/raising critical issues to appropriate team leaders and area management is vital.
• Expertise in MS Office applications, in particular MS Word and Excel, is required. Familiarity with electronic documentation systems and scientific reporting applications (e.g., LIMS, Empower software, ELN/eNotebooks, Infinity) for documenting experiments and routing protocols/reports for review and approval 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!

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Full time,

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