FSP Scientist Pharmaceutical Development

Work Schedule

Environmental Conditions

Job Description

This is a fully onsite role based at our customers 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 withoutsponsorship.

Must be able to pass a comprehensive background check whichincludes a drug screening.

At Thermo Fisher Scientific youll 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 Fishers 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 StylOne 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:

• Bachelors 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

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: Experience:

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