B87 Formulation and Filling Manager
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones.
We need to decide which sections to include based on content.
We have:
- About The Job (description) -> could be "About the role" heading.
- About Sanofi -> could be part of About the role? Might be separate "About Sanofi" but not in allowed list. Allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We should map content to these.
Thus:
- About the role: combine About The Job and About Sanofi? Probably just About The Job description. Could also include About Sanofi as part of About the role.
- Responsibilities: Main Responsibilities and Key Responsibilities (they overlap). We'll combine into a single Responsibilities section with bullet list.
- Requirements: Basic Qualifications (maybe also Preferred Qualifications). Could split into Requirements (basic) and Qualifications (preferred). Allowed headings: Requirements, Qualifications. So we can put Basic Qualifications under Requirements, Preferred Qualifications under Qualifications.
- Skills: KEY COMPETENCIES could be Skills.
- Benefits: What We Offer (including benefits, parental leave, etc.) plus maybe "Why choose us?" but that's more promotional. We'll include Benefits section.
- Pay: Not specified (only "All compensation will be determined commensurate with demonstrated experience." That's placeholder; we should not create Pay section because it's filler. So omit Pay.
- Schedule: Not specified; omit.
We must not include sections with filler. So we will output sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits.
We need to use
for each heading. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to preserve all substantive information, not invent or summarize away detail. So we need to keep the details but can format as lists.
We must remove boilerplate: EEO statement, etc. Also remove duplicated lines. Also remove application instructions (none). Remove cookie/navigation/legal.
We need to ensure we don't include placeholders like "commensurate with experience". That appears in "All compensation will be determined commensurate with demonstrated experience." That's a sentence about compensation; we are omitting Pay section entirely, so we can drop that sentence. Also "Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here." That's generic; we could keep as part of Benefits? It's somewhat generic but still substantive? Might be considered boilerplate. Safer to omit that sentence.
We need to keep "Why choose us?" content? It's promotional but includes some specifics: "Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave." That's specific benefits. Also "Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply." etc. Might be considered benefits. We'll incorporate into Benefits section.
We need to avoid duplication: Main Responsibilities and Key Responsibilities have overlapping items; we should combine and deduplicate.
Let's extract substantive content.
First, About The Job paragraph:
"This Production Manager B87 Aseptic Filling & Formulation will lead aseptic filling and formulation operations in a new, state-of-the-art facility during a critical startup and qualification phase. You will be responsible for the overall safety, quality, compliance, productivity, and performance of your assigned team as the facility progresses through Development Aseptic Process Simulations (media fills) in Q4 2026 and Process Performance Qualifications (PPQs) in 2027, with a target of full commercial readiness in 2028. You are a hands-on, forward-thinking leader who brings deep GMP expertise, a digital-first mindset, and the courage to challenge conventional processes. You thrive in dynamic, fast-paced environments and are energized by the opportunity to build something from the ground up. You lead with curiosity, inspire your team to continuously learn and improve, and hold yourself and others accountable to the highest standards. Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster."
About Sanofi paragraph:
"Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives."
We can combine into About the role.
Now Responsibilities: list from Main Responsibilities and Key Responsibilities.
Main Responsibilities bullet points (as sentences):
- Lead startup operations for aseptic filling and formulation in a new facility environment, serving as the operational anchor through all phases of commissioning, qualification, and commercial readiness
- Drive preparation and execution of Development Aseptic Process Simulations (media fills / APS) by Q4 2026
- Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027
- Apply innovative, analytically driven solutions to complex startup and qualification challenges
- Champion a digital-first approach to operations, leveraging technology, data analytics, and digital tools to optimize performance and decision-making
- Challenge conventional processes and drive continuous improvement across the operation
- Build and develop a high-performing, agile team aligned with company values and culture
- Always ensure strict GMP compliance and regulatory readiness
- Work effectively across cross-functional teams in a fast-paced, multi-priority startup environment
- Serve as Subject Matter Expert (SME) for aseptic operations during all Commissioning & Qualification (C&Q) and Validation activities
Key Responsibilities sub-sections:
Startup & Qualification Leadership:
- Lead the operations team through all facility startup, commissioning, and qualification phases
- Drive Execution Of Environmental Monitoring Performance Qualifications (EMPQs)
- Oversee smoke studies and cleanroom qualification activities
- Lead Development Aseptic Process Simulations (media fills) beginning Q4 2026
- Direct PPQ execution in 2027 in accordance with validation protocols and regulatory expectations
- Drive inspection readiness actions to ensure the facility is prepared for regulatory inspection (FDA PAI in 2027)
- Ensure all C&Q activities are executed in compliance with applicable regulatory standards (cGMPs, CBER, WHO, EP, and other governing bodies)
Operational Excellence:
- Own shift performance across aseptic filling and formulation operations in support of startup projects and/or routine manufacturing activities
- Drive execution performance using SMS 2.0 standards, routines, and digital tools
- Leverage digital systems including eOOE, iObeya, SAP, Qualipso, and Ocularis to optimize operations, enable real-time decision-making, and maintain operational visibility
- Lead critical operational functions including 5W2Hs, Gembas, MSV/LSVs, real-time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker audits
- Lead real-time problem solving in a dynamic, evolving environment
- Support on-time closure of quality items and deviations to meet site performance metrics and product release requirements
- Provide analysis and recommendations to management on quality systems matters
- Participate in cost reduction and efficiency initiatives
Leadership & Team Development:
- Build, lead, and develop a highly trained operations team from startup through commercial launch
- Foster a culture of learning, innovation, accountability, and challenging the status quo
- Empower team members and ensure accountability at all levels of the organization
- Demonstrate strong interpersonal and coaching behaviors
- Drive cross-functional collaboration and process optimization across the facility and broader M&S organization
- Assist with team development, training, and competency building throughout all phases
Digital Mindset & Innovation:
- Champion digital transformation initiatives within operations
- Utilize data analytics and digital tools to drive informed, real-time decision-making
- Identify and implement technology-enabled process improvements
- Lead adoption of Industry 4.0 principles within aseptic operations
- Model a digital-first approach and encourage the team to leverage available technology to its fullest potential
We need to deduplicate: many items repeat (e.g., lead startup operations, drive preparation and execution of media fills, oversee PPQ, champion digital-first, etc.). We'll combine unique items.
Let's create a unified list:
- Lead startup operations for aseptic filling and formulation in a new facility environment, serving as the operational anchor through all phases of commissioning, qualification, and commercial readiness.
- Lead the operations team through all facility startup, commissioning, and qualification phases.
- Drive preparation and execution of Development Aseptic Process Simulations (media fills / APS) by Q4 2026.
- Lead Development Aseptic Process Simulations (media fills) beginning Q4 2026.
- Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027.
- Direct PPQ execution in 2027 in accordance with validation protocols and regulatory expectations.
- Drive inspection readiness actions to ensure the facility is prepared for regulatory inspection (FDA PAI in 2027).
- Ensure all C&Q activities are executed in compliance with applicable regulatory standards (cGMPs, CBER, WHO, EP, and other governing bodies).
- Apply innovative, analytically driven solutions to complex startup and qualification challenges.
- Champion a digital-first approach to operations, leveraging technology, data analytics, and digital tools to optimize performance and decision-making.
- Challenge conventional processes and drive continuous improvement across the operation.
- Build and develop a high-performing, agile team aligned with company values and culture.
- Always ensure strict GMP compliance and regulatory readiness.
- Work effectively across cross-functional teams in a fast-paced, multi-priority startup environment.
- Serve as Subject Matter Expert (SME) for aseptic operations during all Commissioning & Qualification (C&Q) and Validation activities.
- Drive Execution Of Environmental Monitoring Performance Qualifications (EMPQs).
- Oversee smoke studies and cleanroom qualification activities.
- Own shift performance across aseptic filling and formulation operations in support of startup projects and/or routine manufacturing activities.
- Drive execution performance using SMS 2.0 standards, routines, and digital tools.
- Leverage digital systems including eOOE, iObeya, SAP, Qualipso, and Ocularis to optimize operations, enable real-time decision-making, and maintain operational visibility.
- Lead critical operational functions including 5W2Hs, Gembas, MSV/LSVs, real-time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker audits.
- Lead real-time problem
for prose. Do NOT repeat job title as heading. Do NOT put Job ID/requisition numbers as headings. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. We need to decide which sections to include based on content. We have: - About The Job (description) -> could be "About the role" heading. - About Sanofi -> could be part of About the role? Might be separate "About Sanofi" but not in allowed list. Allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We should map content to these. Thus: - About the role: combine About The Job and About Sanofi? Probably just About The Job description. Could also include About Sanofi as part of About the role. - Responsibilities: Main Responsibilities and Key Responsibilities (they overlap). We'll combine into a single Responsibilities section with bullet list. - Requirements: Basic Qualifications (maybe also Preferred Qualifications). Could split into Requirements (basic) and Qualifications (preferred). Allowed headings: Requirements, Qualifications. So we can put Basic Qualifications under Requirements, Preferred Qualifications under Qualifications. - Skills: KEY COMPETENCIES could be Skills. - Benefits: What We Offer (including benefits, parental leave, etc.) plus maybe "Why choose us?" but that's more promotional. We'll include Benefits section. - Pay: Not specified (only "All compensation will be determined commensurate with demonstrated experience." That's placeholder; we should not create Pay section because it's filler. So omit Pay. - Schedule: Not specified; omit. We must not include sections with filler. So we will output sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits. We need to use
for each heading. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to preserve all substantive information, not invent or summarize away detail. So we need to keep the details but can format as lists.
We must remove boilerplate: EEO statement, etc. Also remove duplicated lines. Also remove application instructions (none). Remove cookie/navigation/legal.
We need to ensure we don't include placeholders like "commensurate with experience". That appears in "All compensation will be determined commensurate with demonstrated experience." That's a sentence about compensation; we are omitting Pay section entirely, so we can drop that sentence. Also "Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here." That's generic; we could keep as part of Benefits? It's somewhat generic but still substantive? Might be considered boilerplate. Safer to omit that sentence.
We need to keep "Why choose us?" content? It's promotional but includes some specifics: "Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave." That's specific benefits. Also "Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply." etc. Might be considered benefits. We'll incorporate into Benefits section.
We need to avoid duplication: Main Responsibilities and Key Responsibilities have overlapping items; we should combine and deduplicate.
Let's extract substantive content.
First, About The Job paragraph:
"This Production Manager B87 Aseptic Filling & Formulation will lead aseptic filling and formulation operations in a new, state-of-the-art facility during a critical startup and qualification phase. You will be responsible for the overall safety, quality, compliance, productivity, and performance of your assigned team as the facility progresses through Development Aseptic Process Simulations (media fills) in Q4 2026 and Process Performance Qualifications (PPQs) in 2027, with a target of full commercial readiness in 2028. You are a hands-on, forward-thinking leader who brings deep GMP expertise, a digital-first mindset, and the courage to challenge conventional processes. You thrive in dynamic, fast-paced environments and are energized by the opportunity to build something from the ground up. You lead with curiosity, inspire your team to continuously learn and improve, and hold yourself and others accountable to the highest standards. Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster."
About Sanofi paragraph:
"Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives."
We can combine into About the role.
Now Responsibilities: list from Main Responsibilities and Key Responsibilities.
Main Responsibilities bullet points (as sentences):
- Lead startup operations for aseptic filling and formulation in a new facility environment, serving as the operational anchor through all phases of commissioning, qualification, and commercial readiness
- Drive preparation and execution of Development Aseptic Process Simulations (media fills / APS) by Q4 2026
- Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027
- Apply innovative, analytically driven solutions to complex startup and qualification challenges
- Champion a digital-first approach to operations, leveraging technology, data analytics, and digital tools to optimize performance and decision-making
- Challenge conventional processes and drive continuous improvement across the operation
- Build and develop a high-performing, agile team aligned with company values and culture
- Always ensure strict GMP compliance and regulatory readiness
- Work effectively across cross-functional teams in a fast-paced, multi-priority startup environment
- Serve as Subject Matter Expert (SME) for aseptic operations during all Commissioning & Qualification (C&Q) and Validation activities
Key Responsibilities sub-sections:
Startup & Qualification Leadership:
- Lead the operations team through all facility startup, commissioning, and qualification phases
- Drive Execution Of Environmental Monitoring Performance Qualifications (EMPQs)
- Oversee smoke studies and cleanroom qualification activities
- Lead Development Aseptic Process Simulations (media fills) beginning Q4 2026
- Direct PPQ execution in 2027 in accordance with validation protocols and regulatory expectations
- Drive inspection readiness actions to ensure the facility is prepared for regulatory inspection (FDA PAI in 2027)
- Ensure all C&Q activities are executed in compliance with applicable regulatory standards (cGMPs, CBER, WHO, EP, and other governing bodies)
Operational Excellence:
- Own shift performance across aseptic filling and formulation operations in support of startup projects and/or routine manufacturing activities
- Drive execution performance using SMS 2.0 standards, routines, and digital tools
- Leverage digital systems including eOOE, iObeya, SAP, Qualipso, and Ocularis to optimize operations, enable real-time decision-making, and maintain operational visibility
- Lead critical operational functions including 5W2Hs, Gembas, MSV/LSVs, real-time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker audits
- Lead real-time problem solving in a dynamic, evolving environment
- Support on-time closure of quality items and deviations to meet site performance metrics and product release requirements
- Provide analysis and recommendations to management on quality systems matters
- Participate in cost reduction and efficiency initiatives
Leadership & Team Development:
- Build, lead, and develop a highly trained operations team from startup through commercial launch
- Foster a culture of learning, innovation, accountability, and challenging the status quo
- Empower team members and ensure accountability at all levels of the organization
- Demonstrate strong interpersonal and coaching behaviors
- Drive cross-functional collaboration and process optimization across the facility and broader M&S organization
- Assist with team development, training, and competency building throughout all phases
Digital Mindset & Innovation:
- Champion digital transformation initiatives within operations
- Utilize data analytics and digital tools to drive informed, real-time decision-making
- Identify and implement technology-enabled process improvements
- Lead adoption of Industry 4.0 principles within aseptic operations
- Model a digital-first approach and encourage the team to leverage available technology to its fullest potential
We need to deduplicate: many items repeat (e.g., lead startup operations, drive preparation and execution of media fills, oversee PPQ, champion digital-first, etc.). We'll combine unique items.
Let's create a unified list:
- Lead startup operations for aseptic filling and formulation in a new facility environment, serving as the operational anchor through all phases of commissioning, qualification, and commercial readiness.
- Lead the operations team through all facility startup, commissioning, and qualification phases.
- Drive preparation and execution of Development Aseptic Process Simulations (media fills / APS) by Q4 2026.
- Lead Development Aseptic Process Simulations (media fills) beginning Q4 2026.
- Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027.
- Direct PPQ execution in 2027 in accordance with validation protocols and regulatory expectations.
- Drive inspection readiness actions to ensure the facility is prepared for regulatory inspection (FDA PAI in 2027).
- Ensure all C&Q activities are executed in compliance with applicable regulatory standards (cGMPs, CBER, WHO, EP, and other governing bodies).
- Apply innovative, analytically driven solutions to complex startup and qualification challenges.
- Champion a digital-first approach to operations, leveraging technology, data analytics, and digital tools to optimize performance and decision-making.
- Challenge conventional processes and drive continuous improvement across the operation.
- Build and develop a high-performing, agile team aligned with company values and culture.
- Always ensure strict GMP compliance and regulatory readiness.
- Work effectively across cross-functional teams in a fast-paced, multi-priority startup environment.
- Serve as Subject Matter Expert (SME) for aseptic operations during all Commissioning & Qualification (C&Q) and Validation activities.
- Drive Execution Of Environmental Monitoring Performance Qualifications (EMPQs).
- Oversee smoke studies and cleanroom qualification activities.
- Own shift performance across aseptic filling and formulation operations in support of startup projects and/or routine manufacturing activities.
- Drive execution performance using SMS 2.0 standards, routines, and digital tools.
- Leverage digital systems including eOOE, iObeya, SAP, Qualipso, and Ocularis to optimize operations, enable real-time decision-making, and maintain operational visibility.
- Lead critical operational functions including 5W2Hs, Gembas, MSV/LSVs, real-time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker audits.
- Lead real-time problem
for prose. We need to preserve all substantive information, not invent or summarize away detail. So we need to keep the details but can format as lists. We must remove boilerplate: EEO statement, etc. Also remove duplicated lines. Also remove application instructions (none). Remove cookie/navigation/legal. We need to ensure we don't include placeholders like "commensurate with experience". That appears in "All compensation will be determined commensurate with demonstrated experience." That's a sentence about compensation; we are omitting Pay section entirely, so we can drop that sentence. Also "Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here." That's generic; we could keep as part of Benefits? It's somewhat generic but still substantive? Might be considered boilerplate. Safer to omit that sentence. We need to keep "Why choose us?" content? It's promotional but includes some specifics: "Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave." That's specific benefits. Also "Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply." etc. Might be considered benefits. We'll incorporate into Benefits section. We need to avoid duplication: Main Responsibilities and Key Responsibilities have overlapping items; we should combine and deduplicate. Let's extract substantive content. First, About The Job paragraph: "This Production Manager B87 Aseptic Filling & Formulation will lead aseptic filling and formulation operations in a new, state-of-the-art facility during a critical startup and qualification phase. You will be responsible for the overall safety, quality, compliance, productivity, and performance of your assigned team as the facility progresses through Development Aseptic Process Simulations (media fills) in Q4 2026 and Process Performance Qualifications (PPQs) in 2027, with a target of full commercial readiness in 2028. You are a hands-on, forward-thinking leader who brings deep GMP expertise, a digital-first mindset, and the courage to challenge conventional processes. You thrive in dynamic, fast-paced environments and are energized by the opportunity to build something from the ground up. You lead with curiosity, inspire your team to continuously learn and improve, and hold yourself and others accountable to the highest standards. Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster." About Sanofi paragraph: "Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives." We can combine into About the role. Now Responsibilities: list from Main Responsibilities and Key Responsibilities. Main Responsibilities bullet points (as sentences): - Lead startup operations for aseptic filling and formulation in a new facility environment, serving as the operational anchor through all phases of commissioning, qualification, and commercial readiness - Drive preparation and execution of Development Aseptic Process Simulations (media fills / APS) by Q4 2026 - Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027 - Apply innovative, analytically driven solutions to complex startup and qualification challenges - Champion a digital-first approach to operations, leveraging technology, data analytics, and digital tools to optimize performance and decision-making - Challenge conventional processes and drive continuous improvement across the operation - Build and develop a high-performing, agile team aligned with company values and culture - Always ensure strict GMP compliance and regulatory readiness - Work effectively across cross-functional teams in a fast-paced, multi-priority startup environment - Serve as Subject Matter Expert (SME) for aseptic operations during all Commissioning & Qualification (C&Q) and Validation activities Key Responsibilities sub-sections: Startup & Qualification Leadership: - Lead the operations team through all facility startup, commissioning, and qualification phases - Drive Execution Of Environmental Monitoring Performance Qualifications (EMPQs) - Oversee smoke studies and cleanroom qualification activities - Lead Development Aseptic Process Simulations (media fills) beginning Q4 2026 - Direct PPQ execution in 2027 in accordance with validation protocols and regulatory expectations - Drive inspection readiness actions to ensure the facility is prepared for regulatory inspection (FDA PAI in 2027) - Ensure all C&Q activities are executed in compliance with applicable regulatory standards (cGMPs, CBER, WHO, EP, and other governing bodies) Operational Excellence: - Own shift performance across aseptic filling and formulation operations in support of startup projects and/or routine manufacturing activities - Drive execution performance using SMS 2.0 standards, routines, and digital tools - Leverage digital systems including eOOE, iObeya, SAP, Qualipso, and Ocularis to optimize operations, enable real-time decision-making, and maintain operational visibility - Lead critical operational functions including 5W2Hs, Gembas, MSV/LSVs, real-time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker audits - Lead real-time problem solving in a dynamic, evolving environment - Support on-time closure of quality items and deviations to meet site performance metrics and product release requirements - Provide analysis and recommendations to management on quality systems matters - Participate in cost reduction and efficiency initiatives Leadership & Team Development: - Build, lead, and develop a highly trained operations team from startup through commercial launch - Foster a culture of learning, innovation, accountability, and challenging the status quo - Empower team members and ensure accountability at all levels of the organization - Demonstrate strong interpersonal and coaching behaviors - Drive cross-functional collaboration and process optimization across the facility and broader M&S organization - Assist with team development, training, and competency building throughout all phases Digital Mindset & Innovation: - Champion digital transformation initiatives within operations - Utilize data analytics and digital tools to drive informed, real-time decision-making - Identify and implement technology-enabled process improvements - Lead adoption of Industry 4.0 principles within aseptic operations - Model a digital-first approach and encourage the team to leverage available technology to its fullest potential We need to deduplicate: many items repeat (e.g., lead startup operations, drive preparation and execution of media fills, oversee PPQ, champion digital-first, etc.). We'll combine unique items. Let's create a unified list: - Lead startup operations for aseptic filling and formulation in a new facility environment, serving as the operational anchor through all phases of commissioning, qualification, and commercial readiness. - Lead the operations team through all facility startup, commissioning, and qualification phases. - Drive preparation and execution of Development Aseptic Process Simulations (media fills / APS) by Q4 2026. - Lead Development Aseptic Process Simulations (media fills) beginning Q4 2026. - Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027. - Direct PPQ execution in 2027 in accordance with validation protocols and regulatory expectations. - Drive inspection readiness actions to ensure the facility is prepared for regulatory inspection (FDA PAI in 2027). - Ensure all C&Q activities are executed in compliance with applicable regulatory standards (cGMPs, CBER, WHO, EP, and other governing bodies). - Apply innovative, analytically driven solutions to complex startup and qualification challenges. - Champion a digital-first approach to operations, leveraging technology, data analytics, and digital tools to optimize performance and decision-making. - Challenge conventional processes and drive continuous improvement across the operation. - Build and develop a high-performing, agile team aligned with company values and culture. - Always ensure strict GMP compliance and regulatory readiness. - Work effectively across cross-functional teams in a fast-paced, multi-priority startup environment. - Serve as Subject Matter Expert (SME) for aseptic operations during all Commissioning & Qualification (C&Q) and Validation activities. - Drive Execution Of Environmental Monitoring Performance Qualifications (EMPQs). - Oversee smoke studies and cleanroom qualification activities. - Own shift performance across aseptic filling and formulation operations in support of startup projects and/or routine manufacturing activities. - Drive execution performance using SMS 2.0 standards, routines, and digital tools. - Leverage digital systems including eOOE, iObeya, SAP, Qualipso, and Ocularis to optimize operations, enable real-time decision-making, and maintain operational visibility. - Lead critical operational functions including 5W2Hs, Gembas, MSV/LSVs, real-time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker audits. - Lead real-time problem