FSP Scientist Drug Product Analytical

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)

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 provide hands-on analytical support for drug product formulation and process development of parenteral pharmaceutical products across preclinical and clinical development. Design execute and interpret analytical studies that enable formulation selection stability assessment process optimization in-use and compatibility evaluations and investigation of product quality attributes. Serve as a laboratory-based analytical scientist with extensive HPLC expertise particularly reversed-phase HPLC and size-exclusion chromatography working closely with formulation scientists to generate high-quality decision-enabling data.

Key responsibilities:

• Collaborate closely with Pharmaceutical Development Analytical Development Research/Discovery.
• Design and execute analytical testing to support preformulation formulation screening and optimization process development container-closure compatibility in-use studies and phase-appropriate parenteral drug product development.
• Plan and execute scientifically rigorous studies including stability and stress studies to understand the impact of formulation composition and process parameters on drug product critical quality attributes.
• Perform routine and non-routine analytical testing of formulation and process-development samples including assay/purity and degradation-product analysis by reversed-phase HPLC and aggregate/fragment analysis by size-exclusion chromatography (SEC).
• Execute optimize and troubleshoot fit-for-purpose analytical methods used to support formulation stability and process-development studies.
• Support laboratory investigations and troubleshooting of unexpected analytical results method performance issues and drug product stability or process-related observations.
• Operate troubleshoot and maintain HPLC/UPLC instrumentation and associated chromatography data systems; contribute to evaluation and implementation of analytical technologies needed to support parenteral drug product development.
• Prepare review and maintain laboratory notebooks test methods protocols reports data summaries and other pharmaceutical development documentation with a high standard of scientific integrity and data quality.
• Analyze and trend analytical data clearly communicate conclusions and limitations and connect analytical results to formulation and process-development decisions.
• Manage laboratory organization ordering consumables and coordinating future lab buildout as necessary.
• May train colleagues on analytical methods instrumentation and laboratory procedures as appropriate.
• Perform other duties as assigned.

Education and Experience:

• Bachelors 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)
• 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:

• Common Knowledge & Skills
• Demonstrates ability to work independently or as part of a team.
• Consistently identifies anomalous or inconsistent data determines root cause and implements scientifically sound solutions with minimal oversight.
• Demonstrates deep practical expertise in chromatographic analysis and applies analytical science to solve complex formulation stability and process-development problems.
• Strong command of scientific principles methods and techniques with ability to translate theory into practical development solutions.
• Demonstrated proficiency with HPLC/UPLC systems and chromatography data analysis; able to troubleshoot chromatographic instrument sample-preparation and method-performance issues independently.
• Strong analytical thinking and creative problem-solving skills in a cross-functional matrix environment.
• Excellent written and verbal communication skills including preparation of technical reports and delivery of scientific presentations to internal and external stakeholders.
• Detail-oriented while maintaining awareness of broader scientific regulatory and commercial implications.
• Demonstrates accountability for own work and project outcomes
• Job-Specific Knowledge & Qualifications
• Strong understanding of analytical laboratory practices data integrity and phase-appropriate GxP expectations supporting pharmaceutical development.
• Extensive hands-on HPLC experience is required including reversed-phase chromatography for assay purity and degradation-product analysis and size-exclusion chromatography (SEC) for aggregate and/or fragment analysis.
• Hands-on experience supporting formulation stability or process-development studies for parenteral drug products is preferred.
• Experience interpreting chromatographic data and using analytical results to assess formulation and process effects degradation pathways product stability and critical quality attributes.
• Experience with ion-exchange chromatography (IEX) is preferred but not required. Familiarity with complementary parenteral drug product characterization techniques such as pH osmolality SoloVPE particulates (HIAC & MFI) cIEF ceSDS or other physicochemical methods is a plus.
• Experience generating reviewing and summarizing analytical data for development reports stability programs investigations and CMC documentation is preferred.
• Working knowledge of ICH and regulatory expectations relevant to analytical testing stability and parenteral drug product development is a plus.
• Ability to prioritize work under tight timelines

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 $31.00$38.00.

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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