Scientist Analytical Development Reference Standard

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.)

Job Description

ONSITE:

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.

Key responsibilities:

The Analytical Development Scientist- Reference Standards is responsible for the development qualification and lifecycle management of compendial and internal reference standards supporting small-molecule programs. This role executes and supports analytical method development verification and validation activities to ensure the suitability of testing used for identity purity potency and stability assessments. The scientist performs data-driven evaluation of materials across all stages of development in compliance with GMP safety and regulatory requirements and collaborates cross-functionally to support CMC strategies and regulatory submissions.

• Develops qualifies and executes analytical methods for the characterization qualification and lifecycle management of reference standards and working standards for peptides and small-molecule programs including compendial and non-compendial materials.
• Applies and optimizes compendial (USP/EP/JP) and non-compendial analytical methods to support identity purity potency content and stability testing of reference standards drug substances drug products raw materials and critical reagents.
• Supports method development verification and validation activities to ensure suitability of analytical procedures used for reference standard qualification and routine testing across development stages.
• Performs analytical testing using a variety of instrumental techniques (e.g. chromatography spectroscopy as applicable) in compliance with GMP safety and regulatory requirements.
• Evaluates analytical data investigates atypical results and contributes to documentation supporting reference standard qualification change control and regulatory submissions (IND/IMPD/NDA/BLA).
• Collaborates with CMC Analytical Development Quality Control and external vendors to ensure availability comparability and traceability of internal and compendial reference standards.
• 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 substances 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:

• Bachelors 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:

• 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: Experience:

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