Jobs · Analyst · New Jersey

Principal Scientist Stability

Bristol Myers Squibb EU Policy · New Brunswick, NJ · 1 mo ago
Analyst$122k–$147k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes a paragraph at start about culture etc. That could be "About the role" or maybe "About the company". The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We need to include sections only when posting has real specific content. We have content for: About the role (the introductory paragraph about culture and purpose). Responsibilities (Key Responsibilities). Qualifications & Experience (Qualifications). Benefits (Benefits). Pay (Compensation Overview). Possibly Schedule? Not present. Skills? Could be part of Qualifications but we could have Skills section if there is explicit skills list. The posting includes many skill statements within Qualifications. Could treat as Qualifications & Experience. We'll output sections: About the role, Responsibilities, Qualifications, Benefits, Pay. Ensure we don't repeat job title as heading. No Job ID. We'll embed minor metadata maybe in a short p? The posting includes "R1605697 : Principal Scientist Stability" at end; we should drop that. Also we should remove boilerplate like EEO, disability, etc. Also remove application instructions, links? We should keep substantive info but can drop URLs? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should remove the sections: Supporting People With Disabilities, Candidate Rights, Data Protection, etc. Also remove the "How We Work" maybe? It's not boilerplate but maybe considered navigation? It's about work models; could be considered substantive? Might be considered part of role description? It's generic; but maybe we keep? The instruction: Prefer a few substantive sections over many thin ones. The "How We Work" is generic; could be omitted. We'll keep only core sections. We need to preserve all substantive information: the introductory paragraph about culture, purpose, etc. The responsibilities list (many bullet-like sentences). Qualifications list. Benefits paragraph. Compensation overview. We need to format responsibilities as
  • . Similarly qualifications as list? The instruction: Use
    • for any list of duties/requirements/benefits. So we need to turn the responsibilities bullet points into list items. Qualifications also list. Benefits maybe list? The benefits paragraph includes multiple items; we could make list. We must not invent or summarize away detail. Keep all details. Let's extract content. 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. Responsibilities: The section "Key Responsibilities" then a long paragraph with many sentences separated by periods. We need to split into list items each sentence? The instruction: Use
      • for any list of duties/requirements/benefits. So we should convert each distinct responsibility into a
      • . We'll need to parse sentences. Let's list responsibilities sentences: - The Principal Scientist Stability is accountable for the commercial 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, designs and executes required premarket stability program in support of the change. - Perform change control impact assessments and document the stability assessment in change controls. - Review and endorse change controls as an expanded reviewer. - Initiate change controls related to stability operations. - Provide the technical requirements in a Master Stability Protocol, review and approve 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, Annual Product Quality Reviews, and stability related responses to health authority inquiries. - Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards. - Leads work activities involving Change Controls and CAPA’s. - Responsible for stability procedures and ensures consistency with site department and BMS groups procedures. - Participate and/or lead OpEx (Operational Excellence) initiatives to streamline and standardize management of stability programs. - Supports health authority inspections, internal and external. - Independently represents department in cross functional projects. Check if any duplicates: "Responsible for providing experienced guidance and continuing execution to run the business." appears earlier also? Actually earlier we had "Provide the technical requirements..." and later "Responsible for providing experienced guidance and continuing execution to run the business." It's okay. Now Qualifications & Experience: list each bullet. Let's extract: - B.S. Chemistry, Biology, Microbiology, or relevant discipline. - 8 years of relevant work experience required, preferably in a pharmaceutical environment. - Expert 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. - Expert knowledge in 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. - Outstanding 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 and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles. - Expert knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrated ability to recognize anomalous trends or results. - Significant experience in overseeing external service providers involved in stability studies. - Significant experience on health authority inspections on stability programs. - Excellent written and verbal communication skills. - Exhibit strong leadership and decision-making skills. - Advanced 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. - Advanced 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). - 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. We should keep the last sentence as part of qualifications? It's more encouragement; could be included as a paragraph maybe. But we can keep as a

        after list. Benefits: The paragraph: "Benefits Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our 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 should keep the content but maybe drop the URL? The instruction: remove application instructions, but this is a link to benefits; could be considered navigation? Might be okay to keep but it's a link. Safer to keep the text but maybe drop the URL as it's not substantive? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. The URL is substantive? It's a reference; but could be considered navigation. I'd keep the sentence without the URL? Might be safer to keep the sentence but remove the URL? The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This link is not exactly those; it's a benefits link. Might be okay to keep. However, we might just keep the sentence without the URL to avoid navigation. I'd keep the sentence but maybe strip the URL. The sentence: "U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits". That's basically a pointer; could be considered navigation. I'd remove that sentence. Thus benefits content: list of items. We'll turn into

        • each distinct benefit. Let's parse: - wellbeing support - retirement and financial protection benefits - insurance offerings (medical, dental, vision, life and disability) - Flexible Time Off (FTO) for U.S.-based exempt employees: 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. We'll make each as
        • . Pay: Compensation Overview paragraph: "Compensation Overview New Brunswick - NJ - US: $121,520 - $147,249 The 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." We'll make a

          with that content. Now we need to output HTML fragment with

          headings and content. Structure:

          About the role

          ...

          Responsibilities

          • ...
          • ...

          Qualifications

          • ...
          • ...

          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.

          Benefits

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