Sr. Specialist, Aseptic Observation Program
Bristol Myers Squibb EU Policy · Bothell, WA · 1 mo ago
Project Management$97k–$117k/yrFull-time
We need to output HTML fragment with sections: h3 headings for sections present: About the role? Actually we have Position Summary, Duties/Responsibilities, Qualifications, Skills & Abilities, Working Conditions, Shifts (Schedule), Compensation Overview (Pay), Benefits, How We Work? but we must only include sections when real specific content. Also we must not repeat job title as heading. We must not include Job ID / requisition numbers as headings; we can fold minor metadata into a short p or drop it. The posting includes a lot of boilerplate (EEO, etc.) we must remove.
We need to preserve all substantive information. So we need to extract:
- Position Summary: description of role responsibilities (training, observing, evaluating aseptic practices...). We'll put under for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can map: Position Summary -> About the role. Duties/Responsibilities -> Responsibilities. Qualifications -> Qualifications (Education/Experience). Skills & Abilities -> Skills. Working Conditions -> maybe not a standard heading but we could include under Responsibilities? But we have schedule and pay sections. Working Conditions could be part of Responsibilities? But we have separate schedule and pay. The instruction says include a section ONLY when posting has real specific content for it. So we can include Working Conditions as a section? Not in the list of example headings but we could still use
About the role
maybe? The instruction says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can map: Position Summary -> About the role. Duties/Responsibilities -> Responsibilities. Qualifications -> Qualifications (Education/Experience). Skills & Abilities -> Skills. Working Conditions -> maybe not a standard heading but we could include under Responsibilities? But we have schedule and pay sections. Working Conditions could be part of Responsibilities? But we have separate schedule and pay. The instruction says include a section ONLY when posting has real specific content for it. So we can include Working Conditions as a section? Not in the list of example headings but we could still use for any section heading? The instruction says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies those are typical but we can also use other headings? Probably we should stick to those headings; but we can also include Working Conditions under Responsibilities or maybe as a separate section with heading like Working Conditions (still ). The instruction didn't forbid other headings, just gave examples. Safer to include Working Conditions as its own Working Conditions
. Similarly Schedule as Schedule
. Pay as Pay
. Benefits as Benefits
. Also we have "How We Work" maybe not needed. Also "Supporting People With Disabilities" etc are boilerplate to remove.
We must not include cookie/navigation/legal/EEO etc. So we strip those.
We need to preserve all substantive information: include details like:
- Position Summary: The Aseptic Observation Program (AOP) Sr. Specialist is responsible for training, observing, and evaluating aseptic practices within the manufacturing environment to ensure compliance with regulatory requirements and internal procedures. This role supports the maintenance of a contamination-free environment by observing, documenting, and providing feedback on aseptic techniques, behaviors, and processes. The specialist serves as the manufacturing subject matter expert in aseptic behaviors and practices, collaborating with cross-functional teams for investigations, drive continuous improvement in aseptic operations, and supporting training initiatives.
- Responsibilities (list): bullet points from Duties/Responsibilities.
- Qualifications: Education/Experience: Bachelor’s Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent with a minimum of 4 years of relevant experience in biologic or cell therapy. Knowledge of regulatory requirements, including current Good Manufacturing Practices (cGMP), Good Practices (GxP), 21 CFR Part 11, Good Documentation Practices (GDP), and Annex 1. Excellent observational, documentation, and communication skills. Ability to work independently and collaboratively in a fast-paced environment. Experience with training or coaching operators is a plus. Experience with ergonomics relating to aseptic techniques and aseptic behaviors. Experience with electronic quality management systems. Experience with cleaning and sanitization practices.
- Skills & Abilities: Certification in aseptic processing or quality assurance. Experience with sterile injectable products. Experience with electronic quality systems. Knowledge of cGMPs. Cell therapy and aseptic processing experience is required. Ability to collaborate and influence cross-functional teams. Experience with leading change management is preferred.
- Working Conditions: Must be able to work in a cleanroom environment that requires gowning within ISO 5/7 (Grade A/B). Must be able to stand for extended periods of time. Work in areas that may have strong magnets. Work in areas where handling human blood products (Biosafety Level 2) may be required. May work in areas with exposure to vapor phase liquid nitrogen. Must be able to gown in and be present in the Grade A/B environment for extended periods of time.
- Schedule: Shifts Sun - Wed: 7am - 5:30pm Sun - Wed: Noon - 10:30pm Wed - Sat: 7am - 5:30pm Wed - Sat: Noon - 10:30pm
- Pay: Compensation Overview Bothell - WA - US: $96,832 - $117,338 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 should not include the link? Probably we can keep as plain text; but it's a URL, it's okay.
We must not include application instructions, etc.
We need to output only HTML fragment, no /, no markdown fences.
We'll structure:
About the role
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies those are typical but we can also use other headings? Probably we should stick to those headings; but we can also include Working Conditions under Responsibilities or maybe as a separate section with heading like Working Conditions (still ). The instruction didn't forbid other headings, just gave examples. Safer to include Working Conditions as its own Working Conditions
. Similarly Schedule as Schedule
. Pay as Pay
. Benefits as Benefits
. Also we have "How We Work" maybe not needed. Also "Supporting People With Disabilities" etc are boilerplate to remove.
We must not include cookie/navigation/legal/EEO etc. So we strip those.
We need to preserve all substantive information: include details like:
- Position Summary: The Aseptic Observation Program (AOP) Sr. Specialist is responsible for training, observing, and evaluating aseptic practices within the manufacturing environment to ensure compliance with regulatory requirements and internal procedures. This role supports the maintenance of a contamination-free environment by observing, documenting, and providing feedback on aseptic techniques, behaviors, and processes. The specialist serves as the manufacturing subject matter expert in aseptic behaviors and practices, collaborating with cross-functional teams for investigations, drive continuous improvement in aseptic operations, and supporting training initiatives.
- Responsibilities (list): bullet points from Duties/Responsibilities.
- Qualifications: Education/Experience: Bachelor’s Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent with a minimum of 4 years of relevant experience in biologic or cell therapy. Knowledge of regulatory requirements, including current Good Manufacturing Practices (cGMP), Good Practices (GxP), 21 CFR Part 11, Good Documentation Practices (GDP), and Annex 1. Excellent observational, documentation, and communication skills. Ability to work independently and collaboratively in a fast-paced environment. Experience with training or coaching operators is a plus. Experience with ergonomics relating to aseptic techniques and aseptic behaviors. Experience with electronic quality management systems. Experience with cleaning and sanitization practices.
- Skills & Abilities: Certification in aseptic processing or quality assurance. Experience with sterile injectable products. Experience with electronic quality systems. Knowledge of cGMPs. Cell therapy and aseptic processing experience is required. Ability to collaborate and influence cross-functional teams. Experience with leading change management is preferred.
- Working Conditions: Must be able to work in a cleanroom environment that requires gowning within ISO 5/7 (Grade A/B). Must be able to stand for extended periods of time. Work in areas that may have strong magnets. Work in areas where handling human blood products (Biosafety Level 2) may be required. May work in areas with exposure to vapor phase liquid nitrogen. Must be able to gown in and be present in the Grade A/B environment for extended periods of time.
- Schedule: Shifts Sun - Wed: 7am - 5:30pm Sun - Wed: Noon - 10:30pm Wed - Sat: 7am - 5:30pm Wed - Sat: Noon - 10:30pm
- Pay: Compensation Overview Bothell - WA - US: $96,832 - $117,338 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 should not include the link? Probably we can keep as plain text; but it's a URL, it's okay.
We must not include application instructions, etc.
We need to output only HTML fragment, no /, no markdown fences.
We'll structure:
About the role
Working Conditions
. Similarly Schedule asSchedule
. Pay asPay
. Benefits asBenefits
. Also we have "How We Work" maybe not needed. Also "Supporting People With Disabilities" etc are boilerplate to remove. We must not include cookie/navigation/legal/EEO etc. So we strip those. We need to preserve all substantive information: include details like: - Position Summary: The Aseptic Observation Program (AOP) Sr. Specialist is responsible for training, observing, and evaluating aseptic practices within the manufacturing environment to ensure compliance with regulatory requirements and internal procedures. This role supports the maintenance of a contamination-free environment by observing, documenting, and providing feedback on aseptic techniques, behaviors, and processes. The specialist serves as the manufacturing subject matter expert in aseptic behaviors and practices, collaborating with cross-functional teams for investigations, drive continuous improvement in aseptic operations, and supporting training initiatives. - Responsibilities (list): bullet points from Duties/Responsibilities. - Qualifications: Education/Experience: Bachelor’s Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent with a minimum of 4 years of relevant experience in biologic or cell therapy. Knowledge of regulatory requirements, including current Good Manufacturing Practices (cGMP), Good Practices (GxP), 21 CFR Part 11, Good Documentation Practices (GDP), and Annex 1. Excellent observational, documentation, and communication skills. Ability to work independently and collaboratively in a fast-paced environment. Experience with training or coaching operators is a plus. Experience with ergonomics relating to aseptic techniques and aseptic behaviors. Experience with electronic quality management systems. Experience with cleaning and sanitization practices. - Skills & Abilities: Certification in aseptic processing or quality assurance. Experience with sterile injectable products. Experience with electronic quality systems. Knowledge of cGMPs. Cell therapy and aseptic processing experience is required. Ability to collaborate and influence cross-functional teams. Experience with leading change management is preferred. - Working Conditions: Must be able to work in a cleanroom environment that requires gowning within ISO 5/7 (Grade A/B). Must be able to stand for extended periods of time. Work in areas that may have strong magnets. Work in areas where handling human blood products (Biosafety Level 2) may be required. May work in areas with exposure to vapor phase liquid nitrogen. Must be able to gown in and be present in the Grade A/B environment for extended periods of time. - Schedule: Shifts Sun - Wed: 7am - 5:30pm Sun - Wed: Noon - 10:30pm Wed - Sat: 7am - 5:30pm Wed - Sat: Noon - 10:30pm - Pay: Compensation Overview Bothell - WA - US: $96,832 - $117,338 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 should not include the link? Probably we can keep as plain text; but it's a URL, it's okay. We must not include application instructions, etc. We need to output only HTML fragment, no /, no markdown fences. We'll structure:About the role
...position summary...
Responsibilities
- ... ...
Qualifications
...education/experience...
...knowledge of regulatory requirements...
... maybe combine into paragraphs. Better to keep as paragraphs.Skills
- ...
Working Conditions
...
Schedule
...
Pay
...
Benefits
...
Make sure not to include any filler like "commensurate with experience". We have none. Check for any duplicated lines: we should not repeat. Now craft the HTML. Let's write the content precisely. Position Summary text: "The Aseptic Observation Program (AOP) Sr. Specialist is responsible for training, observing, and evaluating aseptic practices within the manufacturing environment to ensure compliance with regulatory requirements and internal procedures. This role supports the maintenance of a contamination-free environment by observing, documenting, and providing feedback on aseptic techniques, behaviors, and processes. The specialist serves as the manufacturing subject matter expert in aseptic behaviors and practices, collaborating with cross-functional teams for investigations, drive continuous improvement in aseptic operations, and supporting training initiatives." Note: "drive" should be "drives"? but we keep as given. Responsibilities list items: - Observe aseptic operations (e.g., filling, media preparation, gowning) to ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements. - Document observations in real-time and areas for improvement. - Provide immediate feedback and coaching to operators and managers regarding aseptic technique, gowning, and compliance. - Perform staff Aseptic Processing and Gowning Qualifications. - Participate in root cause analysis and investigations related to aseptic process deviations or contamination events. - Performs document revisions as needed to improve instructions and training. - Support the development and delivery of aseptic technique training programs. - Collaborate with Quality Assurance, Manufacturing, and MSAT teams to implement corrective and preventive actions. - Maintain detailed records and reports of observations, findings, and recommendations. - Stay current with industry best practices, regulatory updates, and training related to aseptic processing. - Assist in internal and external audits as a subject matter expert for aseptic operations. - May support APS, CRC, and EMPQ activities through aseptic observations. Note: Some items have weird capitalization; keep as is. Qualifications paragraphs: Paragraph1: "Bachelor’s Degree in cell biology, biotechnology, biochemistry, microbiology, life sciences, or equivalent with a minimum of 4 years of relevant experience in biologic or cell therapy." Paragraph2: "Knowledge of regulatory requirements, including current Good Manufacturing Practices (cGMP), Good Practices (GxP), 21 CFR Part 11, Good Documentation Practices (GDP), and Annex 1." Paragraph3: "Excellent observational, documentation, and communication skills." Paragraph4: "Ability to work independently and collaboratively in a fast-paced environment." Paragraph5: "Experience with training or coaching operators is a plus." Paragraph6: "Experience with ergonomics relating to aseptic techniques and aseptic behaviors." Paragraph7: "Experience with electronic quality management systems." Paragraph8: "Experience with cleaning and sanitization practices." Skills list: - Certification in aseptic processing or quality assurance. - Experience with sterile injectable products. - Experience with electronic quality systems. - Knowledge of cGMPs. - Cell therapy and aseptic processing experience is required. - Ability to collaborate and influence cross-functional teams. - Experience with leading change management is preferred. Working Conditions paragraph: combine sentences. "Must be able to work in a cleanroom environment that requires gowning within ISO 5/7 (Grade A/B). Must be able to stand for extended periods of time. Work in areas that may have strong magnets. Work in areas where handling human blood products (Biosafety Level 2) may be required. May work in areas with exposure to vapor phase liquid nitrogen. Must be able to gown in and be present in the Grade A/B environment for extended periods of time." Schedule paragraph: "Shifts Sun - Wed: 7am - 5:30pm; Sun - Wed: Noon - 10:30pm; Wed - Sat: 7am - 5:30pm; Wed - Sat: Noon - 10:30pm" Pay paragraph: include the compensation overview text. "Compensation Overview Bothell - WA - US: $96,832 - $117,338. 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