Jobs · Analyst · New Jersey

Scientist Stability

Bristol Myers Squibb EU Policy · 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, Key Responsibilities, Qualifications & Experience, Compensation Overview, Benefits, How We Work, Supporting People With Disabilities, Candidate Rights, Data Protection. However we must only include sections when posting has real, specific content for it. We must not include filler like "commensurate with experience". We need to use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. The instruction says use those headings for sections. But we need to map content accordingly. The posting includes Position Summary (could be About the role). Responsibilities (Key Responsibilities). Qualifications & Experience (Qualifications). Skills maybe part of Qualifications. Benefits (Benefits). Pay (Compensation Overview). Schedule not present (no schedule info) so we should not include Schedule section. Also we should not repeat job title as heading. Also we should not include Job ID/requisition numbers as headings; we can fold minor metadata into a short

or drop it. The posting ends with "R1605870 : Scientist Stability". That's job ID should be dropped or placed in a short p maybe but we can drop it. We need to preserve all substantive information, not invent or summarize away detail. Remove boilerplate like cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we need to strip out sections like "Supporting People With Disabilities", "Candidate Rights", "Data Protection", "How We Work" maybe? Those are not in the allowed headings list; but we could still include them if they have real content? The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies we should only use those headings; other headings should not be used. Likely we should omit those sections unless we can map them to allowed headings. "How We Work" could be considered About the role? Not exactly. But we could incorporate its content into About the role or maybe omit as not required headings. The instruction: "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't forbid other headings, but says use those for section headings. Probably we should stick to those headings only. So we need to map content to those sections. We have: - About the role: could include the introductory paragraph about Bristol Myers Squibb purpose-driven culture, and Position Summary. - Responsibilities: Key Responsibilities. - Requirements: Qualifications & Experience (including education, years experience, knowledge). - Qualifications: maybe same as Requirements? But we have both Requirements and Qualifications as separate possible headings. Could split: Requirements = mandatory qualifications (education, years experience). Qualifications = preferred/knowledge/skills. Skills = specific skills (software, etc). Benefits = Benefits section. Pay = Compensation Overview. Schedule: none, so omit. We must not create sections with filler text. So we need to ensure each section has substantive content. 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." 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." We can combine intro and Position Summary into About the role. Responsibilities: list of bullet points from Key Responsibilities. Need to preserve all substantive info; we should not summarize away detail. So we need to list each responsibility as
  • . The list is long; we need to include each bullet. Let's extract bullet points from Key Responsibilities: - 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 keep them as is. Requirements: education and years experience: "B.S. Chemistry, Biology, Microbiology, or relevant discipline. 5 years of relevant work experience required, preferably in a pharmaceutical environment." Qualifications: maybe the in-depth knowledge etc. Let's list: - 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). Skills: maybe the "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 more a note; could be included under Skills or maybe omitted as boilerplate? It's not a skill list. Could be omitted. Benefits: The Benefits section includes description: "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 need to keep all that. Pay: Compensation Overview: "New Brunswick - NJ - US: $91,070 - $110,354 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." Schedule: none, so omit. We also need to not include duplicated lines. Ensure we don't repeat. Now produce HTML fragment with sections:

    About the role

    then

    ... combined intro and Position Summary.

    Then

    Responsibilities

    then
    • ... each bullet.
    Then

    Requirements

    then

    ... maybe combine education and years experience as a paragraph or list? Could be

    B.S. Chemistry, Biology, Microbiology, or relevant discipline. 5 years of relevant work experience required, preferably in a pharmaceutical environment.

    Then

    Qualifications

    then
    • ... each qualification bullet.
    Then

    Skills

    maybe we can include the note about hiring for skills and capabilities? Or we could omit Skills if no specific skill list beyond those already in Qualifications. But we have advanced knowledge of Microsoft office etc already in Qualifications; maybe we treat those as Skills. However the instruction says use those headings; we can decide to put the software knowledge under Skills. But we already have them in Qualifications; maybe better to move them to Skills to avoid duplication. Let's split: Qualifications = knowledge areas (ICH, cGMP, US/EU/ROW, DS/DP manufacturing, analytical/microbiology methods). Skills = technical skills: drive development, authorship investigations, stats software, overseeing external providers, health authority inspections, communication skills, teamwork, prioritizing, MS Office, LIMS, QMS, stats software. That seems reasonable. Thus we need to extract qualifications list (knowledge) and skills list (abilities/software). Let's delineate. Knowledge (Qualifications): - 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
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