FSP - Research Scientist - Analytical Development Stability at Thermo Fisher Scientific

San Diego, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiopharmaceuticalIndustries

Requirements

Bachelor's degree in lab sciences such as Chemistry or similar (with comparable 8+ years of previous experience that provides the knowledge, skills, and abilities to perform the job)
OR Master's degree and previous experience that provides the knowledge, skills, and abilities to perform the job
Experienced user of document management systems such as Veeva Quality and Veeva RIM
Ability to use statistical software such as SLIMStat
Ability to work independently managing multiple stability programs with high complexity
Ability to lead multiple stability programs with moderate to high complexity within CMC
Conducts work in compliance with safety and regulatory requirements
Works in laboratory setting with some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Responsibilities

Independently manages multiple stability programs with high complexity for development stage pharmaceutical compounds (drug substances and drug products)
Reviews stability protocols, reports, and data from internal labs and contract service organizations (CSOs)
Supports shelf-life/retest dating, data trending, and specification revision for drug substances and drug products
Coordinates internal stability samples for storage and testing
Tracks stability test schedules at contract service organizations (CSOs)
Reviews and/or approves stability protocols
Reviews, summarizes, and trends stability data with statistical software such as SLIMStat
Determines shelf life or retest periods
Generates stability protocols, reports, and presentations
Coordinates communication with internal customers and external vendors
Reviews and approves specifications, change controls, out-of-specification (OOS), out-of-trend (OOT) and deviation reports
Facilitates and leads investigations for out of specification and out of trend results in stability studies
Authors and/or reviews Department SOPs related to stability programs
Authors and/or reviews appropriate development reports and stability related sections of regulatory filings, such as INDs, IMPDs, NDAs, etc
Supports Quality Assurance on quality systems and compliance activities, including audit functions, as needed
Serves as a stability lead for a CMC project team or a working group
Assists in method development and validation activities as needed
Provides training and / or supervision to junior staff
Responsible for resource allocation to achieve team objectives and goals
Develops and evaluates personnel to ensure the efficient operation of the function
Leads department initiatives
Performs other duties as assigned
May provide supervisory role for junior employees

Skills

Stability Testing

Analytical Development

Stability Protocols

Data Trending

Shelf-life Studies

Specification Revision

GMP Compliance

Regulatory Compliance

Sample Coordination

Laboratory Safety

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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