FSP – Research Scientist – Analytical Development Stability Full-time

Job Title

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.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/biopharmaceutical company, all while maintaining full-time benefits.

Key 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. Conducts work in compliance with safety and regulatory requirements. May provides supervisory role for junior employees.
• Responsible for resource allocation to achieve team objectives and goals.
• Develops and evaluates personnel to ensure the efficient operation of the function.
• Manages multiple stability programs independently for development-stage pharmaceutical products (drug substances and drug product) for ICH, bulk hold, patient in-use, cycling studies, etc.:
• 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.
• Ability to lead multiple stability programs with moderate to high complexity within CMC.
• Coordinates communication with internal customers and external vendors.
• Coordinates internal stability samples for storage and testing.
• 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.
• Experienced user for document management systems such as Veeva Quality and Veeva RIM.
• 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.
• Leads department initiatives.
• Performs other duties as assigned.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry or similar
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 8+years')
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ years')
• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years')

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:

• Good understanding of how the team/work area relates to other areas and how to improve efficiency and produce high quality work on problems with cross factional impact.
• Identifies and resolves technical, operational, and organizational problems or problems relating to own discipline.
• Frequently works cross functionally as the representative for their areas.
• Ability to meet deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
• Strong project management skills.
• Strong knowledge in stability protocol design under different storage conditions, packaging configurations, and climatic zones.
• Strong knowledge in trending quality attributes such as degradation products and shelf-life extension.
• Strong knowledge of specifications, method validation and transfer.
• Previous stability management and analytical data review experience is highly desired.
• Experience in managing CSOs.
• Familiar with bulk hold, patient in-use, and cycling studies.
• Working knowledge of formulation development for oral and parenteral products and DS process development.
• Familiar with degradation pathways and forced degradation studies.
• Strong knowledge of GMPs, quality systems, and FDA and ICH guidelines, such as ICHQ1.
• Highly knowledgeable of standard analytical techniques (HPLC, GC, FTIR, XRPD, Dissolution and wet chemistry).
• Excellent oral and written communication skills with strong interpersonal skills.
• Competency in Word, Excel, PowerPoint, and statistical analysis software such as JMP, SLIMStat, or Minitab.
• Contributes to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration.

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!

The salary range estimated for this position based in California is $125,000.00–$135,000.00.

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