Thermo Fisher Scientific
FSP - Research Scientist - Small Molecule Analytical Development Stability
Thermo Fisher Scientific, San Diego, California, United States, 92189
Overview
This is a fully onsite role based at our customer’s site in San Diego, CA. We welcome applicants from all locations within the US. Relocation assistance is not provided; any relocation costs will be the candidate’s responsibility. Must be legally authorized to work in the United States without sponsorship. Must pass a comprehensive background check, which includes a drug screening. This role is within the Analytical Services team and supports stability programs for development-stage pharmaceutical substances and drug products. Within our Analytical Services team, the Functional Service Provider (FSP) solution enables customers to leverage our staff’s expertise while you gain direct experience working onsite at a pharmaceutical/biopharmaceutical company, with 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 provide 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 products) 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. Leads 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, OOS, 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 stability-related sections of regulatory filings (e.g., INDs, IMPDs, NDAs). Experience with 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. 8+ years of related experience (or equivalent) for a Bachelor’s degree. Or Master’s degree with 6+ years of related experience (or equivalent). Or PhD with 4+ years of related experience (or equivalent). In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient for the role. Knowledge, Skills and Abilities
Strong understanding of how the team/work area relates to other areas and how to improve efficiency and quality on cross-functional problems. Ability to identify and resolve technical, operational, and organizational problems within the discipline. Ability to work cross-functionally as the representative for their area. Ability to meet deadlines across multiple projects with high accuracy. Strong project management skills. Knowledge in stability protocol design under various storage conditions, packaging configurations, and climatic zones. Knowledge in trending quality attributes such as degradation products and shelf-life extension. Knowledge of specifications, method validation and transfer. Experience in stability management and analytical data review is highly desired. Experience in managing CSOs. Familiarity with bulk hold, patient in-use, and cycling studies. Working knowledge of formulation development for oral and parenteral products and drug substance process development. Familiar with degradation pathways and forced degradation studies. Strong knowledge of GMPs, quality systems, and FDA/ICH guidelines (e.g., ICH Q1). Proficiency with standard analytical techniques (HPLC, GC, FTIR, XRPD, Dissolution, and wet chemistry). Excellent oral and written communication skills and strong interpersonal abilities. Competency in Word, Excel, PowerPoint, and statistical analysis tools (e.g., JMP, SLIMStat, Minitab). Contributes to a professional, respectful, collaborative work environment. Working Environment
Able to communicate and collaborate with diverse groups effectively. Able to work upright/standing for typical hours and to lift/move up to 25 pounds. Able to work in non-traditional environments and use standard office equipment with proficiency. May have exposure to potentially hazardous elements in research/lab settings. Capable of performing under pressure while prioritizing multiple projects. Benefits and Compensation
Salary range estimated for California: $125,000.00–$135,000.00. Eligible for a variable annual bonus based on company, team, and/or individual performance. Comprehensive Total Rewards package including medical/dental/vision plans, health incentive programs, and other benefits. Paid time off, holidays, parental leave, disability coverage, retirement plans, and employee stock purchase plan (ESPP). For more information on benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
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This is a fully onsite role based at our customer’s site in San Diego, CA. We welcome applicants from all locations within the US. Relocation assistance is not provided; any relocation costs will be the candidate’s responsibility. Must be legally authorized to work in the United States without sponsorship. Must pass a comprehensive background check, which includes a drug screening. This role is within the Analytical Services team and supports stability programs for development-stage pharmaceutical substances and drug products. Within our Analytical Services team, the Functional Service Provider (FSP) solution enables customers to leverage our staff’s expertise while you gain direct experience working onsite at a pharmaceutical/biopharmaceutical company, with 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 provide 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 products) 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. Leads 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, OOS, 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 stability-related sections of regulatory filings (e.g., INDs, IMPDs, NDAs). Experience with 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. 8+ years of related experience (or equivalent) for a Bachelor’s degree. Or Master’s degree with 6+ years of related experience (or equivalent). Or PhD with 4+ years of related experience (or equivalent). In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient for the role. Knowledge, Skills and Abilities
Strong understanding of how the team/work area relates to other areas and how to improve efficiency and quality on cross-functional problems. Ability to identify and resolve technical, operational, and organizational problems within the discipline. Ability to work cross-functionally as the representative for their area. Ability to meet deadlines across multiple projects with high accuracy. Strong project management skills. Knowledge in stability protocol design under various storage conditions, packaging configurations, and climatic zones. Knowledge in trending quality attributes such as degradation products and shelf-life extension. Knowledge of specifications, method validation and transfer. Experience in stability management and analytical data review is highly desired. Experience in managing CSOs. Familiarity with bulk hold, patient in-use, and cycling studies. Working knowledge of formulation development for oral and parenteral products and drug substance process development. Familiar with degradation pathways and forced degradation studies. Strong knowledge of GMPs, quality systems, and FDA/ICH guidelines (e.g., ICH Q1). Proficiency with standard analytical techniques (HPLC, GC, FTIR, XRPD, Dissolution, and wet chemistry). Excellent oral and written communication skills and strong interpersonal abilities. Competency in Word, Excel, PowerPoint, and statistical analysis tools (e.g., JMP, SLIMStat, Minitab). Contributes to a professional, respectful, collaborative work environment. Working Environment
Able to communicate and collaborate with diverse groups effectively. Able to work upright/standing for typical hours and to lift/move up to 25 pounds. Able to work in non-traditional environments and use standard office equipment with proficiency. May have exposure to potentially hazardous elements in research/lab settings. Capable of performing under pressure while prioritizing multiple projects. Benefits and Compensation
Salary range estimated for California: $125,000.00–$135,000.00. Eligible for a variable annual bonus based on company, team, and/or individual performance. Comprehensive Total Rewards package including medical/dental/vision plans, health incentive programs, and other benefits. Paid time off, holidays, parental leave, disability coverage, retirement plans, and employee stock purchase plan (ESPP). For more information on benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
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