Associate Director, Sterility Assurance
for section headings. Use - for any list of duties/requirements/benefits. Use
for prose.
We must preserve all substantive info, not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. The posting includes Equal Opportunities, Accommodations, etc. Those are boilerplate; we should remove them. Also "About Moderna", "Our Working Model", etc might be considered boilerplate? They are substantive about company but not required? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. "About Moderna" is not EEO; it's company description. Might be okay to keep? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep company description if it's substantive. However they said prefer a few substantive sections over many thin ones. Could combine About Moderna and Working Model into maybe "About Moderna" section. But we already have About the role. Could add a section "About Moderna". However they said use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). They gave examples but not limited to those. We can add other headings if needed. But they said "include a section ONLY when the posting has real, specific content for it". So we can include About Moderna if it has real specific content. It does.
But we need to avoid duplication. The posting also includes "Equal Opportunities" and "Accommodations" which are boilerplate EEO etc; we should remove.
Thus sections: About the role (from The Role paragraph). Responsibilities (Key Responsibilities and Authorities). Requirements (Required Background). Benefits (Pay & Benefits). About Moderna (company description). Working Model maybe separate? Could be part of About Moderna or separate section. Since it's specific content about work model, we could include a section "Working Model". But they said prefer few substantive sections over many thin ones. Could combine Working Model into About Moderna? Might be okay to have separate.
But we need to ensure we don't create sections with filler like "commensurate with experience". Not present.
We need to use
for each heading.
Inside each section, we need to format content: use
for prose,
- for lists.
We need to extract lists: Responsibilities have many bullet-like sentences but not explicitly bulleted. We could turn each responsibility into
- . Similarly Requirements: Education, Experience, Other Quantifiable Preference (list). Benefits: list of benefits.
We must preserve all substantive info; not invent or summarize away detail. So we need to keep each responsibility sentence as is.
Let's parse.
The Role paragraph:
"The Associate Director, Sterility Assurance, DP Manufacturing is a senior technical role dedicated to the MTC-E facility and accountable for the design, implementation, and oversight of the site’s Contamination Control Strategy (CCS) program. This role ensures sterility assurance activities are aligned with regulatory expectations, operational requirements, and best practices in aseptic manufacturing. This is a high-impact, hands-on role requiring frequent presence on the manufacturing floor to observe, assess, and improve aseptic behaviors, process execution, and contamination control practices. The Associate Director partners closely with Manufacturing, MS&T, Facilities, QC, Engineering, Supply Chain, and Quality to integrate sterility assurance into all layers of site operations. The individual must be technically strong, data-driven, and proactive in identifying risks and driving continuous improvement across the site."
We'll put that in
.
Responsibilities: list each sentence after "Lead and maintain..." etc.
Let's extract:
- Lead and maintain the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with EU Annex 1, FDA aseptic guidance, and internal quality expectations.
- Ensure practical, risk-based integration of the CCS into isolator operations, cleanroom design, gowning practices, material and personnel flow, environmental controls, and aseptic process execution.
- Provide sterility assurance expertise for site changes, process improvements, and operational decisions that may impact contamination control.
- Provide expert sterility assurance guidance on the EM program (strategy, zoning, sampling design, alert/action levels, and trending) and partner with QC to ensure effective monitoring and response aligned with contamination control strategy.
- Lead or support investigations with potential impact to sterility assurance (e.g., EM excursions, media fill failures, decontamination issues, bioburden or sterility failures), ensuring robust root cause analysis and effective corrective and preventive actions.
- Present EM performance, contamination control risks, and key trends to site leadership and drive data-based decision-making.
- Own and author sterility assurance-related Quality System documentation, including change controls, risk assessments, CAPAs, deviations, and other records associated with contamination control, EM, or aseptic practices. Ensure records are scientifically sound, timely, and aligned with site and global quality system requirements.
- Serve as a key leader in inspection and audit readiness activities, including internal audits, client audits, and regulatory inspections. Act as subject matter expert for CCS, EM, aseptic execution, isolator operations, media fills, and related sterility assurance topics.
- Lead or support drafting of inspection responses and implementation of remediation actions arising from audit or inspection findings.
- Support real-time issue resolution and verify execution of validated and approved aseptic practices.
- Conduct routine floor audits and observations to assess aseptic behaviors, gowning, EM practices, and adherence to contamination controls.
- Coach operations and support personnel and partner with QA leadership to reinforce expectations and strengthen sterile execution culture.
- Support the site aseptic training, qualification, and certification programs.
- Partner closely with Operations, Facilities, MS&T, QC, Engineering, Supply Chain, and Quality to proactively manage sterility assurance risks across site activities.
- Identify and assign appropriate deputies to support business in times of absence.
- Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
That's many items.
Requirements: Education, Experience, Other Quantifiable Preference (list). Let's extract:
Education: Bachelor’s degree in Microbiology, Life Sciences, Pharmacy, or related field (Master’s or Ph.D. preferred)
Experience: 8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles
Other Quantifiable Preference:
- Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations.
- Strong expertise in risk assessment facilitation.
- Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership.
- Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
We'll put these as
- .
Benefits: The Pay & Benefits section includes descriptive paragraphs. Let's extract:
"At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras"
We can turn each line into
- . Also the introductory sentences could be
.
About Moderna: paragraph(s). Let's extract:
"Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities."
We can keep as
.
Working Model: paragraph(s). Extract:
"As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment."
We can keep as
.
We must not include EEO etc.
Now produce HTML fragment.
Structure:
About the role
...
Responsibilities
- ...
...
Requirements
Education: Bachelor’s degree in Microbiology, Life Sciences, Pharmacy, or related field (Master’s or Ph.D. preferred)
Experience: 8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles
- Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations.
- Strong expertise in risk assessment facilitation.
- Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership.
- Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
Alternatively could combine Education and Experience as but they are not list items; but we can keep as .
Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.
- Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities to help you
for prose. We must preserve all substantive info, not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. The posting includes Equal Opportunities, Accommodations, etc. Those are boilerplate; we should remove them. Also "About Moderna", "Our Working Model", etc might be considered boilerplate? They are substantive about company but not required? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. "About Moderna" is not EEO; it's company description. Might be okay to keep? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep company description if it's substantive. However they said prefer a few substantive sections over many thin ones. Could combine About Moderna and Working Model into maybe "About Moderna" section. But we already have About the role. Could add a section "About Moderna". However they said use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). They gave examples but not limited to those. We can add other headings if needed. But they said "include a section ONLY when the posting has real, specific content for it". So we can include About Moderna if it has real specific content. It does. But we need to avoid duplication. The posting also includes "Equal Opportunities" and "Accommodations" which are boilerplate EEO etc; we should remove. Thus sections: About the role (from The Role paragraph). Responsibilities (Key Responsibilities and Authorities). Requirements (Required Background). Benefits (Pay & Benefits). About Moderna (company description). Working Model maybe separate? Could be part of About Moderna or separate section. Since it's specific content about work model, we could include a section "Working Model". But they said prefer few substantive sections over many thin ones. Could combine Working Model into About Moderna? Might be okay to have separate. But we need to ensure we don't create sections with filler like "commensurate with experience". Not present. We need to use
for each heading. Inside each section, we need to format content: use
for prose,
- for lists. We need to extract lists: Responsibilities have many bullet-like sentences but not explicitly bulleted. We could turn each responsibility into
- . Similarly Requirements: Education, Experience, Other Quantifiable Preference (list). Benefits: list of benefits.
We must preserve all substantive info; not invent or summarize away detail. So we need to keep each responsibility sentence as is.
Let's parse.
The Role paragraph:
"The Associate Director, Sterility Assurance, DP Manufacturing is a senior technical role dedicated to the MTC-E facility and accountable for the design, implementation, and oversight of the site’s Contamination Control Strategy (CCS) program. This role ensures sterility assurance activities are aligned with regulatory expectations, operational requirements, and best practices in aseptic manufacturing. This is a high-impact, hands-on role requiring frequent presence on the manufacturing floor to observe, assess, and improve aseptic behaviors, process execution, and contamination control practices. The Associate Director partners closely with Manufacturing, MS&T, Facilities, QC, Engineering, Supply Chain, and Quality to integrate sterility assurance into all layers of site operations. The individual must be technically strong, data-driven, and proactive in identifying risks and driving continuous improvement across the site."
We'll put that in
. Responsibilities: list each sentence after "Lead and maintain..." etc. Let's extract: - Lead and maintain the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with EU Annex 1, FDA aseptic guidance, and internal quality expectations. - Ensure practical, risk-based integration of the CCS into isolator operations, cleanroom design, gowning practices, material and personnel flow, environmental controls, and aseptic process execution. - Provide sterility assurance expertise for site changes, process improvements, and operational decisions that may impact contamination control. - Provide expert sterility assurance guidance on the EM program (strategy, zoning, sampling design, alert/action levels, and trending) and partner with QC to ensure effective monitoring and response aligned with contamination control strategy. - Lead or support investigations with potential impact to sterility assurance (e.g., EM excursions, media fill failures, decontamination issues, bioburden or sterility failures), ensuring robust root cause analysis and effective corrective and preventive actions. - Present EM performance, contamination control risks, and key trends to site leadership and drive data-based decision-making. - Own and author sterility assurance-related Quality System documentation, including change controls, risk assessments, CAPAs, deviations, and other records associated with contamination control, EM, or aseptic practices. Ensure records are scientifically sound, timely, and aligned with site and global quality system requirements. - Serve as a key leader in inspection and audit readiness activities, including internal audits, client audits, and regulatory inspections. Act as subject matter expert for CCS, EM, aseptic execution, isolator operations, media fills, and related sterility assurance topics. - Lead or support drafting of inspection responses and implementation of remediation actions arising from audit or inspection findings. - Support real-time issue resolution and verify execution of validated and approved aseptic practices. - Conduct routine floor audits and observations to assess aseptic behaviors, gowning, EM practices, and adherence to contamination controls. - Coach operations and support personnel and partner with QA leadership to reinforce expectations and strengthen sterile execution culture. - Support the site aseptic training, qualification, and certification programs. - Partner closely with Operations, Facilities, MS&T, QC, Engineering, Supply Chain, and Quality to proactively manage sterility assurance risks across site activities. - Identify and assign appropriate deputies to support business in times of absence. - Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements. - Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions. - Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections. - Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence. That's many items. Requirements: Education, Experience, Other Quantifiable Preference (list). Let's extract: Education: Bachelor’s degree in Microbiology, Life Sciences, Pharmacy, or related field (Master’s or Ph.D. preferred) Experience: 8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles Other Quantifiable Preference: - Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations. - Strong expertise in risk assessment facilitation. - Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership. - Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations. We'll put these as
- . Benefits: The Pay & Benefits section includes descriptive paragraphs. Let's extract: "At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras" We can turn each line into
- . Also the introductory sentences could be
. About Moderna: paragraph(s). Let's extract: "Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities." We can keep as
. Working Model: paragraph(s). Extract: "As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment." We can keep as
. We must not include EEO etc. Now produce HTML fragment. Structure:
About the role
...
Responsibilities
- ... ...
Requirements
Education: Bachelor’s degree in Microbiology, Life Sciences, Pharmacy, or related field (Master’s or Ph.D. preferred)
Experience: 8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles
- Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations.
- Strong expertise in risk assessment facilitation.
- Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership.
- Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
- but they are not list items; but we can keep as
- Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Family planning benefits, including fertility, adoption, and surrogacy support
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities to help you
.
Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.