Jobs · Analyst · New Jersey

Scientist Stability

Bristol Myers Squibb · New Brunswick, NJ · 1 mo ago
Analyst$91k–$110k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes a paragraph about company purpose, then Position Summary, then Key Responsibilities, then Qualifications & Experience, then Compensation Overview, then Benefits, then How We Work, then Supporting People With Disabilities, Candidate Rights, Data Protection. However we must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Also remove "Supporting People With Disabilities", "Candidate Rights", "Data Protection" as they are likely legal/EEO boilerplate. Also remove "How We Work" maybe not boilerplate? It's about work models; could be considered substantive? Might be considered generic but it's specific to BMS. The instruction: "Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions." "Supporting People With Disabilities", "Candidate Rights", "Data Protection" are legal/EEO boilerplate, so remove. "How We Work" maybe not boilerplate but could be considered generic; but it's about work models and includes links. Might be considered not essential but could be kept? The instruction says prefer a few substantive sections over many thin ones. We could keep About the role (the initial paragraph), Position Summary, Responsibilities, Qualifications, Compensation, Benefits. Possibly also "How We Work" but it's thin. Better to omit. We must not repeat job title as heading. So no heading for Scientist Stability. We need to use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use
  • for any list of duties/requirements/benefits, and

    for prose. We need to preserve all substantive information. So we need to extract details. Let's parse the posting: Intro paragraph: "At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it." That's About the role / company overview. Position Summary: "The Scientist Stability is responsible for stability product strategy and contributes to the oversight of product stability programs for commercial large molecule Drug Substances and Drug Products. Activities include those associated with product stability strategy, stability program requirements, authoring stability protocols, and preparation and review of stability reports and regulatory filings. Responsibilities include supporting stability operations and logistics where needed to provide experienced guidance and continuing execution to run the business." Key Responsibilities: a long list bullet-like sentences. We need to turn into

    • . Each sentence seems a responsibility. Qualifications & Experience: list of qualifications: B.S. Chemistry, Biology, Microbiology, or relevant discipline. 5 years of relevant work experience required, preferably in a pharmaceutical environment. In-depth knowledge of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility. Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices. Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods. Good skills to drive development of technical or scientific initiatives for solving complex problems/issues; recommending and drive science-based decisions/ implementation of solutions. Experience with authorship of investigations, interpret results, and generate technical conclusions consistent with Quality management principles. Knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrated ability to recognize anomalous trends or results. Experience in overseeing external service providers involved in stability studies. Experience on health authority inspections on stability programs. Excellent written and verbal communication skills. Ability to work independently and collaboratively in a team matrix environment, contribute to a team based environment, promoting a high commitment to business goals and objectives. Ability to prioritize objectives from multiple projects and adapt to quick changes in schedules to accommodate priority requests. Advanced knowledge of Microsoft office applications, LIMS (Laboratory Information Management System), Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP). Also note: "We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway." That's maybe a note but could be considered boilerplate? It's encouraging to apply; maybe keep as prose? It's not a requirement. Might be considered generic but could be kept. However instruction: prefer few substantive sections; we could include it in Qualifications as a note. Compensation Overview: includes salary range: New Brunswick - NJ - US: $91,070 - $110,354. Starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance. Benefits: paragraph about comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits We need to output sections: About the role (maybe heading "About the role"), Responsibilities (heading "Responsibilities"), Qualifications (heading "Qualifications"), Pay (heading "Pay"), Benefits (heading "Benefits"). We should not include "Requirements" separate if we have Qualifications. We need to use

      for each section heading. Inside sections, use

      for prose,

      • for lists. For Responsibilities: we need to list each responsibility as
      • . The responsibilities are many sentences; we can split by sentences. Let's extract responsibilities from the "Key Responsibilities" paragraph. It starts after "Key Responsibilities". The text: "The Scientist Stability is accountable for the biologics stability program on assigned brand(s) and acts as Stability Product Lead. Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing & Supply requirements. Develops stability data where gaps exist. Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products’ performance/stability profile. Serves as stability representative on project teams covering post-approval changes, and supports execution of the required premarket stability program in support of the change. Perform change control impact assessments and document the stability assessment in change controls. Initiate change controls related to stability operations. Provide the technical requirements in a Master Stability Protocol, review study specific protocols and / or batch enrollment forms. Responsible for handling annual commercial stability program for assigned products in coordination with sample management groups. Responsible for providing experienced guidance and continuing execution to run the business. Authors stability sections of CTD (Common Technical Document) dossiers for post-approval filings, annual reports, product renewals, and Annual Product Quality Reviews (APQRs). Serves as stability representative for OOT/OOS investigations and other investigations related to potential quality issues and/or deviations from standards. Supports work activities involving Change Controls and CAPA’s. Responsible for stability procedures and ensures consistency with site department and BMS groups procedures. Participate in OpEx (Operational Excellence) initiatives to streamline and standardize management of stability programs. Supports health authority inspections, internal and external. Represents the department in cross functional projects. Ensures training requirements are met." We need to ensure each is a separate
      • . Some sentences start with capital verbs; we keep as is. Qualifications: we need to list each qualification as
      • maybe. The qualifications are many bullet-like statements separated by periods. We'll split. List: - B.S. Chemistry, Biology, Microbiology, or relevant discipline. - 5 years of relevant work experience required, preferably in a pharmaceutical environment. - In-depth knowledge of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents. - A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility. - Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices. - Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods. - Good skills to drive development of technical or scientific initiatives for solving complex problems/issues; recommending and drive science-based decisions/ implementation of solutions. - Experience with authorship of investigations, interpret results, and generate technical conclusions consistent with Quality management principles. - Knowledge of evaluation and interpretation of stability data using statistics software. - Review data and demonstrated ability to recognize anomalous trends or results. - Experience in overseeing external service providers involved in stability studies. - Experience on health authority inspections on stability programs. - Excellent written and verbal communication skills. - Ability to work independently and collaboratively in a team matrix environment, contribute to a team based environment, promoting a high commitment to business goals and objectives. - Ability to prioritize objectives from multiple projects and adapt to quick changes in schedules to accommodate priority requests. - Advanced knowledge of Microsoft office applications, LIMS (Laboratory Information Management System), Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP). Also note the encouragement statement: "We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway." Could be included as a

        after list. Pay: we need to include salary range and details. Could be a

        with the range and additional info. Benefits: we need to include the benefits description. Could be a

        with the details; maybe also a

          for list of benefits? The benefits paragraph includes multiple items; we could turn into list. But instruction: Use
          • for any list of duties/requirements/benefits. So we should convert benefits into list. Let's extract benefits items: - Comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). - U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. - Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. -

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Scientist Stability

Bristol Myers Squibb EU PolicyNew Brunswick, NJ· 1 mo ago
Analyst$91k–$110k/yrapply on jobs.bms.com