Associate Director, Aseptic Process and Design
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. So we need to parse content.
We have:
- Intro paragraph: "At Bristol Myers Squibb, our employees often ask...". That's about company culture, purpose. Could be "About the role" or maybe "Overview". We'll treat as "About the role".
- Key Responsibilities: list of responsibilities with subheadings (Aseptic Process & Facility Design, Process Development, Optimization & Scale-Up, Qualification, Validation & Lifecycle Management, Aseptic Process Simulation (APS) & Media Fill Program, Contamination Control & Sterility Assurance, Regulatory Compliance & Quality Integration, Cross-Functional Collaboration & Technical Leadership). We need to output - for any list of duties/requirements/benefits. So we need to list each bullet as
- . The subheadings could be part of the li text or we could embed them as strong? Probably just include them in li text.
- Qualifications & Experience: includes Education Required, Experience, etc. That's qualifications. We'll output as list.
- Travel: "This position requires up to 25% of travel." That's maybe a detail under Qualifications? Could be separate but not a heading. We'll include in qualifications list.
- Preferred: M.S. etc. That's also qualifications.
- Compensation Overview: includes pay ranges for locations. That's Pay section. We need to include Pay heading only if posting actually states them. Yes, they have pay ranges. So we output
Pay
then maybe a with the ranges. Could also list as
but instruction: Use - for any list of duties/requirements/benefits. Pay is not a list but we can use
. We'll include the ranges.
- Benefits: they have a Benefits paragraph. So we output
Benefits
then with description.
- Schedule: Not mentioned explicitly. No schedule details besides maybe travel. So we omit Schedule.
- Skills: Not separate; qualifications cover skills. Could we have a Skills section? Not needed.
- How We Work etc: that's extra but maybe not needed; it's about work models. Could be considered "About the role" or maybe we could add a section "Work Model". But instruction only lists certain headings; we can add others if needed? It says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings but suggests those as examples. Safer to stick to those. The "How We Work" could be considered part of About the role. We'll incorporate into About the role paragraph.
- Supporting People With Disabilities etc: that's EEO boilerplate; we should remove.
- Candidate Rights etc: remove.
- Data Protection etc: remove.
- Job ID etc: drop.
Thus final HTML:
About the role
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. Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities.
Responsibilities
- Aseptic Process & Facility Design: Design and develop aseptic manufacturing processes, including fill/finish operations and sterile processing systems. Define cleanroom layouts, material/personnel flows, and environmental control strategies to minimize contamination risks. Support sites in evaluating and selecting equipment and technologies for aseptic manufacturing (e.g., filling lines, isolators, RABS, and sterilization systems).
- Process Development, Optimization & Scale-Up: Establish microbial critical process parameters (CPPs) and develop robust aseptic manufacturing formulas. Lead process optimization efforts to improve yield, reliability, and sterility assurance. Support scale-up and technology transfer from development to commercial manufacturing.
- Qualification, Validation & Lifecycle Management: Support and/or lead commissioning and qualification (IQ/OQ/PQ) of aseptic systems and production lines. Develop and execute process validation strategies, including media fills and continued process verification. Ensure processes remain in control through lifecycle monitoring and continuous improvement.
- Aseptic Process Simulation (APS) & Media Fill Program: Define the enterprise APS/media fill strategy, including program governance, intervention classification, acceptance criteria, and continuous improvement expectations. Provide expert oversight and standardization of smoke study program design and execution, ensuring aerodynamic qualification of aseptic processing zones aligns with current regulatory and industry standards. Establish and maintain enterprise-level policies governing media fill frequency, unit operation coverage, failure investigation protocols, and remediation pathways. Facilitate cross-site learning and consistency in APS program design across the BMS network by sharing best practices, regulatory trends, and lessons learned — supporting continuous improvement while respecting site program ownership.
- Contamination Control & Sterility Assurance: Support sites in integrating Contamination Control & Sterility (CCS) requirements into process design and operational practices across facilities, equipment, and processes. Assess risks related to microbial contamination and define mitigation strategies. Integrate environmental monitoring, cleaning validation, and sterilization practices into process design.
- Regulatory Compliance & Quality Integration: Ensure compliance with cGMP, FDA, EU GMP Annex 1, ISO standards, and ICH guidelines. Support regulatory submissions, inspections, and audits with technical documentation. Develop SOPs and technical documentation and provide input on batch records for aseptic processes. Assist sites in developing and maintaining inspection-readiness materials for aseptic process design, CCS, and APS topics; serve as a technical SME resource alongside site teams during regulatory inspections (FDA, EMA, PMDA, and other health authorities).
- Cross-Functional Collaboration & Technical Leadership: Partner with Quality, Manufacturing, Engineering, MS&T and Validation teams to deliver projects. Provide SME support for troubleshooting and deviation investigations. Lead or contribute to capital projects, technology transfers, and process improvements.
Qualifications
- Education Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline.
- Experience: 5–10+ years (mid-level) in aseptic/sterile manufacturing; hands-on experience in cleanroom and aseptic operations environments.
- Strong knowledge of Aseptic processing, sterile manufacturing, and contamination control; Cleanroom design and operation (ISO classifications); Fill/finish operations and sterile filtration; Sterilization technologies (steam, filtration, VHP, etc.).
- Experience with process validation, qualification, and GMP manufacturing systems.
- Familiarity with cGMP (FDA 21 CFR Parts 210/211), EU GMP Annex 1 / ISO 13408 and ICH Q8/Q9/Q10 principles.
- Understanding contamination control strategies and risk-based approaches.
- Ability to perform root cause analysis, risk assessments, and process troubleshooting.
- Strong data analysis and process performance evaluation capabilities.
- Experience with Equipment commissioning and startup, Process optimization and continuous improvement, and Managing timelines and cross-functional deliverables.
- Strong project management and organizational skills.
- Attention to detail and strong documentation discipline.
- Effective communication and cross-functional collaboration.
- Leadership and coaching capability.
- Travel: This position requires up to 25% of travel.
- Preferred: M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline.
- 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.
Pay
Devens - MA - US $173,280 - $209,976; Madison - Giralda - NJ - US $161,950 - $196,246; New Brunswick - NJ - US $161,950 - $196,246; Princeton - NJ - US $161,950 - $196,246. 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.
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 must ensure no extra markdown fences. Just output HTML.
Check for any boilerplate: we removed EEO, legal, etc. Also removed "How We Work" details? We incorporated some into About the role. Good.
Check that we didn't repeat job title as heading. We didn't.
Check that we didn't include Job ID/requisition numbers. We didn't.
Check that we didn't create Pay/Schedule/Benefits unless posting actually states them. We have Pay and Benefits. No Schedule.
Check that we didn't include filler like "commensurate with experience". Not present.
Check that we preserved all substantive information: we kept responsibilities, qualifications, travel, preferred, compensation overview, benefits, about the role, how we work (some). Did we lose any specifics like "Support sites in evaluating and selecting equipment and technologies for aseptic manufacturing (e.g., filling lines, isolators, RABS, and sterilization systems)." Yes included.
Check that we kept "Assist sites in developing and maintaining inspection-readiness materials for aseptic process design, CCS, and APS topics; serve as a technical SME resource alongside
Pay
then maybe awith the ranges. Could also list as
- but instruction: Use
- for any list of duties/requirements/benefits. Pay is not a list but we can use
. We'll include the ranges. - Benefits: they have a Benefits paragraph. So we output
Benefits
thenwith description. - Schedule: Not mentioned explicitly. No schedule details besides maybe travel. So we omit Schedule. - Skills: Not separate; qualifications cover skills. Could we have a Skills section? Not needed. - How We Work etc: that's extra but maybe not needed; it's about work models. Could be considered "About the role" or maybe we could add a section "Work Model". But instruction only lists certain headings; we can add others if needed? It says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings but suggests those as examples. Safer to stick to those. The "How We Work" could be considered part of About the role. We'll incorporate into About the role paragraph. - Supporting People With Disabilities etc: that's EEO boilerplate; we should remove. - Candidate Rights etc: remove. - Data Protection etc: remove. - Job ID etc: drop. Thus final HTML:
About the role
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. Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities.
Responsibilities
- Aseptic Process & Facility Design: Design and develop aseptic manufacturing processes, including fill/finish operations and sterile processing systems. Define cleanroom layouts, material/personnel flows, and environmental control strategies to minimize contamination risks. Support sites in evaluating and selecting equipment and technologies for aseptic manufacturing (e.g., filling lines, isolators, RABS, and sterilization systems).
- Process Development, Optimization & Scale-Up: Establish microbial critical process parameters (CPPs) and develop robust aseptic manufacturing formulas. Lead process optimization efforts to improve yield, reliability, and sterility assurance. Support scale-up and technology transfer from development to commercial manufacturing.
- Qualification, Validation & Lifecycle Management: Support and/or lead commissioning and qualification (IQ/OQ/PQ) of aseptic systems and production lines. Develop and execute process validation strategies, including media fills and continued process verification. Ensure processes remain in control through lifecycle monitoring and continuous improvement.
- Aseptic Process Simulation (APS) & Media Fill Program: Define the enterprise APS/media fill strategy, including program governance, intervention classification, acceptance criteria, and continuous improvement expectations. Provide expert oversight and standardization of smoke study program design and execution, ensuring aerodynamic qualification of aseptic processing zones aligns with current regulatory and industry standards. Establish and maintain enterprise-level policies governing media fill frequency, unit operation coverage, failure investigation protocols, and remediation pathways. Facilitate cross-site learning and consistency in APS program design across the BMS network by sharing best practices, regulatory trends, and lessons learned — supporting continuous improvement while respecting site program ownership.
- Contamination Control & Sterility Assurance: Support sites in integrating Contamination Control & Sterility (CCS) requirements into process design and operational practices across facilities, equipment, and processes. Assess risks related to microbial contamination and define mitigation strategies. Integrate environmental monitoring, cleaning validation, and sterilization practices into process design.
- Regulatory Compliance & Quality Integration: Ensure compliance with cGMP, FDA, EU GMP Annex 1, ISO standards, and ICH guidelines. Support regulatory submissions, inspections, and audits with technical documentation. Develop SOPs and technical documentation and provide input on batch records for aseptic processes. Assist sites in developing and maintaining inspection-readiness materials for aseptic process design, CCS, and APS topics; serve as a technical SME resource alongside site teams during regulatory inspections (FDA, EMA, PMDA, and other health authorities).
- Cross-Functional Collaboration & Technical Leadership: Partner with Quality, Manufacturing, Engineering, MS&T and Validation teams to deliver projects. Provide SME support for troubleshooting and deviation investigations. Lead or contribute to capital projects, technology transfers, and process improvements.
Qualifications
- Education Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline.
- Experience: 5–10+ years (mid-level) in aseptic/sterile manufacturing; hands-on experience in cleanroom and aseptic operations environments.
- Strong knowledge of Aseptic processing, sterile manufacturing, and contamination control; Cleanroom design and operation (ISO classifications); Fill/finish operations and sterile filtration; Sterilization technologies (steam, filtration, VHP, etc.).
- Experience with process validation, qualification, and GMP manufacturing systems.
- Familiarity with cGMP (FDA 21 CFR Parts 210/211), EU GMP Annex 1 / ISO 13408 and ICH Q8/Q9/Q10 principles.
- Understanding contamination control strategies and risk-based approaches.
- Ability to perform root cause analysis, risk assessments, and process troubleshooting.
- Strong data analysis and process performance evaluation capabilities.
- Experience with Equipment commissioning and startup, Process optimization and continuous improvement, and Managing timelines and cross-functional deliverables.
- Strong project management and organizational skills.
- Attention to detail and strong documentation discipline.
- Effective communication and cross-functional collaboration.
- Leadership and coaching capability.
- Travel: This position requires up to 25% of travel.
- Preferred: M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology or a related scientific discipline.
- 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.
Pay
Devens - MA - US $173,280 - $209,976; Madison - Giralda - NJ - US $161,950 - $196,246; New Brunswick - NJ - US $161,950 - $196,246; Princeton - NJ - US $161,950 - $196,246. 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.
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 must ensure no extra markdown fences. Just output HTML. Check for any boilerplate: we removed EEO, legal, etc. Also removed "How We Work" details? We incorporated some into About the role. Good. Check that we didn't repeat job title as heading. We didn't. Check that we didn't include Job ID/requisition numbers. We didn't. Check that we didn't create Pay/Schedule/Benefits unless posting actually states them. We have Pay and Benefits. No Schedule. Check that we didn't include filler like "commensurate with experience". Not present. Check that we preserved all substantive information: we kept responsibilities, qualifications, travel, preferred, compensation overview, benefits, about the role, how we work (some). Did we lose any specifics like "Support sites in evaluating and selecting equipment and technologies for aseptic manufacturing (e.g., filling lines, isolators, RABS, and sterilization systems)." Yes included. Check that we kept "Assist sites in developing and maintaining inspection-readiness materials for aseptic process design, CCS, and APS topics; serve as a technical SME resource alongside