FSP - Scientist - Analytical Development Testing

ThermoFisher Scientific; San Diego (CA); On-site; USD 43,000 - 52,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Paid time off

Job summary

Thermo Fisher Scientific in San Diego, CA is seeking an analytical scientist to develop and validate instrumental methods for development compounds and materials. You will perform method validation, support testing across drug substances and packaging, and maintain rigorous data records per SOPs.

Role requires onsite work in Carmel Valley, strong teamwork, and adherence to GMP standards. Qualified candidates possess a Chemistry or Biochemistry background with 2+ years of experience or a Master’s

Qualifications

• Bachelor's degree in lab sciences such as Chemistry or Biochemistry
• Scientist: 2+ years’ experience or Master’s degree
• Equivalency considered for education/experience

Responsibilities

• Develops instrumental analytical methods for development compounds and materials.
• Performs method validation and supports testing for drug substances and products.
• Maintains records per SOPs and quality systems.
• Coordinates instrument maintenance and data review with cross-functional teams.

Skills

HPLC

Method validation

Data analysis

Regulatory compliance

Laboratory skills

Education

Bachelor's degree in Chemistry

Master's degree

Tools

HPLC Instruments

GC/FTIR

MS-Excel

Job description

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.)

ONSITE:

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 withoutsponsorship.

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

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.

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:

Develops and executes instrumental methods of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials to develop assays based on new and existing methodologies. Assists in developing and validating testing methodology used to control raw materials, production intermediates, and final products. Conducts work in compliance with safety and regulatory requirements. May provide analysis and evaluation of material and products at all stages of development process.

• Experience with HPLC, method validation and small molecules is required.

• Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials.

• Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making.

• With supervision, plans and executes in-house stability studies for drug substance’s, intermediates, and prototype drug products.

• With supervision and as appropriate, assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results.

• With supervision, collaboratively plans and executes cross functional studies for chemical development and formulation development.

• Recognizes and responds to unexpected or anomalous observations in all activities.

• Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training.

• Provides detailed reviews of peer generated data as well as that generated from contracted service providers.

• Maintains the inventory of laboratory consumables and clean glassware.

• Coordinates vendors service calls for repair and maintenance of laboratory instruments, with training perform routine maintenance of laboratory instrumentation, maintains complete and accurate records of instrument service and repairs in conformance with company SOPs and policies.

• Performs other duties as assigned.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, 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:

• Small molecule experience and HPLC is required

• Recognizes fundamental anomalies in data points and identifies issues in experiments / processes

• Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals

• Strong knowledge of one scientific discipline

• Good knowledge of scientific principles, methods and techniques

• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools

• Ability to work as part of a team of individuals to meet goals, tasks in a timeline driven setting

• Strong computer skills

• Good communications, problem-solving, analytical thinking skills

• Detail oriented

• Ability to meet deadlines

• Good project management skills

• Job Specific Knowledge & Qualifications:

• Proficient in using MS-Excel, MS-Word as well as data systems for computer-controlled instrumentation

• Practical working knowledge of conducting HPLC analysis and troubleshooting

• Some expertise in evaluating analytical data and drawing meaningful conclusions

• Knowledge of cGMP expectations for laboratory records and quality systems

• Ability to provide ideas for process improvements

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: 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.