Principal Scientist Stability

We need to output HTML fragment with sections: About the role? Actually we have a Position Summary and Key Responsibilities etc. We need to use

for section headings: e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include a section only when posting has real specific content. We have content for Position Summary (maybe "About the role") and Responsibilities (Key Responsibilities). We have Qualifications & Experience (Qualifications). We have Compensation Overview (Pay). We have Benefits (Benefits). We have maybe "How We Work" but not required headings. We should not repeat job title as heading. We should not include Job ID/requisition numbers as headings; we can fold minor metadata into short

or drop it. The posting includes "R1605697 : Principal Scientist Stability" at end; we can drop or put in a short p. We need to preserve all substantive information; do not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we need to strip out things like "Supporting People With Disabilities", "Candidate Rights", "Data Protection", "How We Work", etc. Also remove "We hire for skills and capabilities..." maybe keep? That's part of Qualifications? It's a statement encouraging apply; maybe considered boilerplate? It's not exactly EEO but it's a generic encouragement; might be considered boilerplate? The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The "We hire for skills..." is not exactly those; but it's more of a generic encouragement; could be considered part of the posting but not required. Safer to keep it? It's not boilerplate per se, but it's a generic statement. I'd keep it within Qualifications maybe as a p. We need to output only HTML fragment, no /, no markdown fences. Structure:

About the role

Position Summary The Principal Scientist Stability is responsible for stability product strategy and 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 / approving stability protocols, and preparation, review and approval 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.

Responsibilities

• ... each bullet from Key Responsibilities list.

We need to preserve all bullet points. Let's extract them from the text: Key Responsibilities (the block after that heading). Let's list each sentence that starts with a verb. - 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. We need to ensure we keep all. Now Qualifications & Experience section: we need to put under

Qualifications

maybe. The heading list includes Qualifications, Skills. We have qualifications and experience; we could combine into Qualifications. We'll list bullet points for each qualification. Extract qualifications: - 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 could keep the last sentence as a p maybe. Now Compensation Overview: we have Pay range: New Brunswick - NJ - US: $121,520 - $147,249. Also mention additional discretionary incentive cash and stock opportunities. We'll put under

Pay

with p. Benefits: we have a paragraph about benefits: 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'll put under

Benefits

with p (maybe multiple p). We'll keep the link. Schedule: Not mentioned; we should not create Schedule section. Now we need to ensure we don't repeat job title as heading. We'll not include any heading for job title. We also need to include minor metadata like Job ID/requisition numbers folded into short p or drop. We can add a p at top maybe:

Job ID: R1605697

but instruction says do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it. So we can include a short p with the Job ID. We must not include boilerplate like "Supporting People With Disabilities", "Candidate Rights", "Data Protection", "How We Work", etc. Also remove duplicated lines. Ensure we don't include any application instructions like "To check your application status..." etc. Now produce HTML. Let's craft:

Job ID: R1605697

About the role

Position Summary The Principal Scientist Stability is responsible for stability product strategy and 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 / approving stability protocols, and preparation, review and approval 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.

Responsibilities

• 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.

Qualifications

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