FSP - Scientist - Pharmaceutical Development

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting Job Description This is a fully onsite role based at our customer's site in San Diego, CA (Carmel Valley area) 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. As a Scientist you will work as a key lab work contributor and focus on building lab capability for drug product development, support clinical phase development studies for a diverse portfolio of small molecule therapeutics. The successful candidate will be able to adapt quickly to a highly collaborative and fast-paced team environment, flexibly supporting multiple development projects. Key areas of focus include supporting pilot scale manufacturing equipment setup/maintenance, phase appropriate formulation and drug product process development, cGMP processes and documentation, in process physical properties characterization, and independent laboratory operations management to support a scientific staff.

Key responsibilities:

Execute R D drug product experiments, including excipient compatibility, physicochemical characterization, and testing using state-of-the-art analytical instrumentation and techniques. Support Pharmaceutical Development team members with process execution, scale up, and materials generation. Develop and maintain electronic laboratory notebooks to ensure accurate documentation. Collaborate effectively within a team setting to lead the preventive maintenance coordination, troubleshooting, calibration, and repair activities for drug product manufacturing equipment. Serve as liaison for equipment service vendors, managing maintenance schedules and spare parts inventory. Maintain comprehensive equipment inventory including spare parts, change parts, tools, and tooling. Ensure efficient day-to-day laboratory operations through systematic assembly, disassembly, and relocation of product development equipment while maintaining compliance with safety protocols. Coordinate laboratory schedules, optimize resource utilization across teams, and identify opportunities to streamline laboratory processes to drive operational efficiency. Manage laboratory inventory and supplies, ensuring optimal stock levels through strategic ordering and collaboration with colleagues. Coordinate shipping and receiving of laboratory materials while maintaining proper documentation. Implement safety protocols through proper equipment maintenance and laboratory cleanliness standards. Support chemical hygiene and waste disposal programs in coordination with facilities team. Contribute to laboratory upgrades and safety improvements. Collaborate with late-stage drug product development team to understand requirements and enhance laboratory operations. Experience with setup and operation of small molecule unit operations/models such as Styl'One compaction simulator, Gerteis roller compactor, manual encapsulation/ProFill, ILC Dover applications for HP/C handling, Mini/MidiGlatt, Comil, and V-blenders. Experience with chracterziation technologies such as Malvern-particle size analyzer, bulk/tap density analysis, and HPLC analysis.

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 cGMP conduct for batch production processes, good documentation practices, and laboratory operations. Hands-on experience in commonly used characterization instruments for a solid oral drug product lab; A good understanding of the principles of those instruments; ability to independently troubleshoot minor instrument issues. Ability to interpret testing results, identify trends and out-of-trend data points, summarize findings, and make scientific conclusions Excellent at team coordination and training associated with operational excellence and safety implementation. Ability to participate in the design and independently perform development formulation studies for small molecule and biologic drug candidates under direction of scientific staff. Understanding of the basics of GXP compliance and practices is a plus Strong organizational and technical problem-solving abilities Experience supporting manufacturing development and process development is a plus Ability to effectively prioritize tasks and manage multiple projects Acts as a team player and collaborator who can listen effectively and communicate in an open, clear and timely manner Well-trained in Good Documentation Practices (GDP) within the pharmaceutical industry Develops knowledge of scientific principles, methods, and techniques Solid knowledge and experience working with pharmaceutical manufacturing to ensure safety compliance

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 $34.00-$38.01. 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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.