FSP - Scientist - Analytical Chemistry Lab Instrument Support

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP)

Safety Standards, Laboratory Setting, Office Job Description Shift:

Full-Time; Monday - Friday; 8am-5pm

PT ONSITE

This is a fully onsite role based at our customer's site in South San Francisco, CA. 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.

Key responsibilities:

Initiate and maintain the lifecycle of multiple analytical instruments used in testing synthetic molecules. The lifecycle includes initial qualification, calibration, preventative maintenance, troubleshooting and repair, and decommissioning of analytical instrumentation. Provide support to multiple laboratories by ordering supplies, managing inventories, coordinating vendor visits, and helping to maintain GMP status for analytical instrumentation. Provide documentation support in the form of proof-reading, formatting, document control (Condor), and technical writing. Document Control Specialist will support documentation needs for controlled documents throughout the creation, revision, and final approval process Act as a change owner (Trackwise/Veeva) to create change control records for analytical equipment and documents, and review of proposed changes to documents to ensure traceability throughout the document change control process Ensure on-time completion of all routine activities related to instrument lifecycle (e.g., preventative maintenance activities) and change records. Ensure all work is completed efficiently under GMP compliance to maximize operations. Help ensure laboratory compliance by performing routine walk-throughs to detect and mitigate potential environmental, health and safety issues

Education and Experience:

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar

Assoc Scientist:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2 years')

Scientist:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years') 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:

Experience in the qualification, calibration, maintenance, and troubleshooting of GMP instrumentation including, but not limited to, HPLC, GC, LCMS, dissolution testers, titrators, and FTIR. Experience with Document Control processes preferred Strong word processing and proofreading skills a must. Extensive knowledge/experience using MS Word. Experience with Change Records (Trackwise/Veeva) strongly preferred Basic understanding of change control process Exceptional attention to detail and turnaround time Strong understanding of regulatory requirements around

FDA 21 CFR

Part 11, EU Annex 11, GAMP 5, GLP and GMP regulations as well as

ISO 9001 QMS

requirements. Experience working with lab systems (ELN, LIMS, Empower, Chemstation) and processes in a GxP environment is highly desirable Experience serving and developing a strong partnership with clients in a fast-paced environment Laboratory support for analytical chemistry laboratories Ability to work independently or as part of a team utilizing self-motivation, adaptability, and a positive attitude Strong computer skills. Strong Windows OS and permissions skills a plus proactive communication (oral and written); excellent organizational skills including the ability to manage project resource requirements (material, time, etc.), and ability to elevate relevant issues to appropriate leadership Ability to learn new techniques, perform and prioritize multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies and procedures Excellent judgment, troubleshooting and problem solving skills Familiarity with risk based assessments and decision making is highly desirable

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 $35.00-$39.50. 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 This job posting is for multiple levels: The salary range estimated for the second level is: $26.00-$34.50 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.