Thermo Fisher Scientific Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

We are seeking a highly motivated scientist to join our Pharmaceutical Development team. This role will be expected to work as part of a team and focus on pre-clinical and clinical phase drug product development for a diverse portfolio of therapeutic biologics modalities. The successful candidate will be able to work in a fast-paced team environment and be able to learn new skills quickly and to support the multiple development projects. The key area of focus include: supporting clinical in-use study, developmental stability studies, freeze-thaw study and excursion studies, phase appropriate formulation and fill-finish process development; biologics molecule characterization and analysis using state of art bioanalytical methods and equipment including but not limited to ddPCR, SEC-HPLC, and UV-Vis, Protein characterization, CE-SDS, particle size and TCID50.

• Collaborate effectively within a team setting to lead the design, execution, and documentation of internal experimental studies to support phase-appropriate drug product development and clinical material production.

• Serve as the liaison to vendors and collaboration parties for procurement and scientific evaluation of key analytical instruments and process equipment, managing purchases and coordinating material shipments.

• Draft comprehensive development reports, memos, and other scientific documentation throughout the development process.

• Engage in cross-functional collaboration with project management, quality assurance, analytical, R&D, and non-clinical teams to facilitate development work and support manufacturing campaigns.

• Organize and manage internal experiment timelines and assignments within the team to complete lab studies efficiently.

• Act as the key technical and scientific lead in the team for the development of new characterization assays, writing protocols, and managing troubleshooting processes.

• Communicate development progress, timelines, and study results to the manager, ensuring transparency and alignment with project goals.

• Perform physicochemical and bioanalytical characterization and testing using state-of-the-art analytical instrumentation and techniques.

• Preparation of solvents, standards, buffers, and other solutions with proper weighing, record-keeping, and adherence to safety protocols

• Operate and maintain laboratory instrumentation and equipment, and coordinate service with technicians as needed

• Collaborate with and assist other lab scientists in preparing samples and performing other lab support tasks

• Manage documentation for study planning and organization, maintain a laboratory notebook, laboratory inventory, and instrument maintenance schedules.

• Performs other duties as assigned

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Pharmaceutical Sciences or similar

• Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)

• OR Masters 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:

• In depth understanding of bio-chemical and physical properties of therapeutic biologicals including but not limited to proteins and viral particles. Have basic knowledge of protein quantification and characterization methods.

• Experience developing and optimizing methods to characterize protein or virus biologics molecules and understanding the pharmaceutical properties of drug products and formulations.

• Ability to design and perform early-phase formulation studies for biological drug candidates, including screening excipients, and assessing prototype formulation stability to support acceptable shelf-life; experience with Design of Experiments (DoE) is a plus.

• Understanding of the fundamentals and hands-on experience with aseptic processes for the fill-finish of sterile parenteral biological drugs

• Understanding of the basics of GMP compliance for biological drug manufacturing

• Experience of CMO tech transfer is a plus

• Experience of scaling up formulation process and fill-finish is a plus

• Mammalian cell culture, and cell-based assay experience is a plus

• Ability to write comprehensive scientific reports in an efficient manner and summarize the data for presentations and regulatory submissions

• Strong organizational and technical problem-solving abilities

• Experience supporting pharmaceutical product development and transfers to clinical manufacturing is a plus

• Ability to effectively prioritize tasks and manage multiple projects

• Act as a team player and collaborator who can listen effectively and communicate in an open, clear and timely manner

• Ability to execute experiments efficiently, interpret results, and troubleshoot issues

• Well-trained in Good Documentation Practices (GDP) within the pharmaceutical industry

• Developing knowledge of scientific principles, methods, and techniques

• Solid knowledge and experience working with bioanalytical laboratories to ensure safety compliance

• Strong teamwork, communication, problem-solving, analytical thinking, planning, and organizational skills

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 hourly pay range estimated for this position based in California is $26.00–$38.50.

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.