Supervisor, Sterile Operations (M-F, 7am - 3:30pm)
MannKind Corporation · Danbury, CT · 1 mo ago
Manufacturing$84k–$126k/yrFull-time
We need to output HTML fragment with sections: About the role? The posting includes mission statement, values, etc. We need to use for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We must include sections only when posting has real specific content. We have:
- About the role: The position summary (first paragraph after mission) describes role. So we can have About the role section with that content.
- Responsibilities: Essential Duties And Responsibilities list.
- Requirements: Minimum Qualifications (Education, Experience) maybe.
- Qualifications: Could be same as Requirements? But we need separate sections if content exists. The posting has "Minimum Qualifications" and "Required Knowledge, Skills, And Abilities". Also "Physical And Work Environment Requirements". We can map: Requirements could be Education/Experience; Qualifications could be Knowledge, Skills, Abilities; Skills could be maybe part of that; but we need to avoid duplication. The instruction: Prefer a few substantive sections over many thin ones. So we could combine some.
We need to include Pay section because posting states Pay Range: $84,000 - $126,000 per year.
Schedule: posting includes "*This is a 1st Shift role; Monday to Friday from 7:00am to 3:30pm.*" So we have schedule.
Benefits: Not mentioned. So we should not include Benefits section.
We must not repeat job title as heading. Not include Job ID etc.
We must remove boilerplate: mission statement etc? The mission statement is part of About the role? Actually the mission statement is generic company description. It may be considered boilerplate? But it's substantive about company values. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The mission statement is not those; it's okay to keep as part of About the role.
We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to include all details from the posting, but we can format them into sections.
We must not create sections with filler like "commensurate with experience". Not present.
We need to use
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We must include sections only when posting has real specific content. We have:
- About the role: The position summary (first paragraph after mission) describes role. So we can have About the role section with that content.
- Responsibilities: Essential Duties And Responsibilities list.
- Requirements: Minimum Qualifications (Education, Experience) maybe.
- Qualifications: Could be same as Requirements? But we need separate sections if content exists. The posting has "Minimum Qualifications" and "Required Knowledge, Skills, And Abilities". Also "Physical And Work Environment Requirements". We can map: Requirements could be Education/Experience; Qualifications could be Knowledge, Skills, Abilities; Skills could be maybe part of that; but we need to avoid duplication. The instruction: Prefer a few substantive sections over many thin ones. So we could combine some.
We need to include Pay section because posting states Pay Range: $84,000 - $126,000 per year.
Schedule: posting includes "*This is a 1st Shift role; Monday to Friday from 7:00am to 3:30pm.*" So we have schedule.
Benefits: Not mentioned. So we should not include Benefits section.
We must not repeat job title as heading. Not include Job ID etc.
We must remove boilerplate: mission statement etc? The mission statement is part of About the role? Actually the mission statement is generic company description. It may be considered boilerplate? But it's substantive about company values. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The mission statement is not those; it's okay to keep as part of About the role.
We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to include all details from the posting, but we can format them into sections.
We must not create sections with filler like "commensurate with experience". Not present.
We need to use for section headings. Use - for any list of duties/requirements/benefits, and
for prose.
Thus:
About the role
... (position summary plus maybe mission/values?)
But we need to include the mission statement etc? It says "MannKind is committed to developing..." That's about company. Could be part of About the role. We'll include that as prose.
Then Responsibilities: list of duties.
We need to convert the bullet points (they are sentences separated by periods) into - . The duties list includes many sentences each starting with a verb. We'll split each sentence as a list item.
We need to ensure we preserve all details.
Let's extract the duties:
From "Essential Duties And Responsibilities" paragraph:
- Supervise daily sterile manufacturing execution across formulation, component preparation, isolator filling, inspection, and device assembly.
- Convert the approved production schedule into daily work assignments and coordinate operator coverage, equipment readiness, materials, and training needs for the four-operator team.
- Provide direct people supervision, coaching, attendance oversight, performance feedback, and development support in accordance with company policy and in partnership with the Associate Director and Human Resources.
- Verify that operators are appropriately trained and qualified before independent task execution and promptly address or escalate qualification gaps.
- Lead daily tier meetings, shift handoffs, floor communications, and first-line escalation; coordinate routine execution with Quality, Engineering, Validation, MS&T/Technical Operations, Supply Chain, EHS, and Maintenance.
- Serve as the front-line operational point of contact for assigned manufacturing equipment and processes; escalate decisions requiring business-owner, technical-owner, or department-level authority.
- Support equipment commissioning, qualification, process validation, aseptic process simulations/media fills, technology transfer, and production-readiness activities.
- Review batch records, logbooks, forms, and electronic records for completeness, accuracy, contemporaneous documentation, and readiness for formal review.
- Maintain area and personnel inspection readiness and support Sterile Operations during internal audits and health authority inspections.
- Monitor daily safety, quality, delivery, training, and performance indicators; communicate emerging risks and recommend corrective actions to the Associate Director.
That's 10 items.
Now Quality System And Compliance Responsibilities: This could be part of Responsibilities or separate? It's more specific. We could include under Responsibilities as additional list items. But we could also create a separate section? The instruction: Use headings only for those specific headings. We have only those headings allowed. So we must fit all content under those headings. We could put Quality System responsibilities under Responsibilities as well.
Thus Responsibilities list will include both sets.
Now Requirements: Education and Experience.
From Minimum Qualifications:
Education Bachelor’s degree in engineering, microbiology, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific or technical field preferred. An associate degree, technical credential, or equivalent combination of education and directly relevant experience may be considered.
Experience 5-7+ years of pharmaceutical or biotechnology manufacturing experience, preferably including sterile or aseptic operations, with 2+ years of demonstrated lead, supervisory, or people-leadership experience.
We can put these as
- .
Now Qualifications: Required Knowledge, Skills, And Abilities.
List items:
- Working knowledge of sterile drug product manufacturing, aseptic processing, contamination control, cleanroom behavior, EU GMP Annex 1, U.S. FDA 21 CFR Parts 210 and 211, and applicable visual inspection requirements, including USP and .
- Demonstrated ability to supervise personnel and coordinate production in a regulated pharmaceutical or biotechnology environment.
- Sound technical writing and investigation-support skills, including the ability to draft QMS content and provide clear, factual event documentation.
- Ability to interpret batch records, process data, equipment alarms, qualification documents, and production metrics and to escalate abnormal conditions appropriately.
- Strong communication, prioritization, conflict-resolution, coaching, problem-solving, and cross-functional coordination skills.
- Working knowledge of electronic document, training, manufacturing, or quality systems used in regulated operations.
- Ability to make timely floor-level decisions within approved procedures and clearly recognize matters requiring escalation to the Associate Director, Quality, or a designated system owner.
Note there is a trailing ", and ." after USP? The text: "including USP and ." seems truncated; we must preserve as is.
Now Physical And Work Environment Requirements: This could be part of Requirements or Qualifications? It's separate but we could include under Requirements as additional list items. But we already have Requirements for Education/Experience; we could add another subsection? But we only allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We could put Physical requirements under Requirements as well, or under Qualifications. Since we have both Requirements and Qualifications sections, we can allocate: Requirements = Education + Experience + Physical And Work Environment Requirements. Qualifications = Knowledge, Skills, Abilities.
Skills: Could be empty if we already covered skills in Qualifications. But we could create a Skills section if there are distinct skill statements not covered. However the Required Knowledge, Skills, And Abilities already includes skills. To avoid thin sections, we might omit Skills section.
Pay: we have Pay Range.
Schedule: we have shift.
Now we need to output only HTML fragment.
Let's craft:
About the role
MannKind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. We are on a mission to give people control of their health and the freedom to live life. At MannKind, our employees are our number one asset, and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background, thought and perspective is valued and respected. Our team is also energized by the company’s entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly. Our Values serve as the foundation of MannKind’s culture. They define who we are, how we act, and guide our interactions every day—both with each other and the customers we serve. At MannKind, you will work with people who are experts in their fields, see challenges as opportunities, are tenacious and push boundaries, bring creative and solutions-based thinking forward, and always believe in winning together. The Sterile Operations Supervisor reports to the Associate Director, Sterile Operations and provides hands-on, front-line leadership for the daily execution of sterile drug product manufacturing. The role directly supervises the operator team, coordinates shift activities, and ensures safe, compliant, and reliable execution across the complete process train. The Supervisor supports assigned quality system documents and events, implements approved requirements on the manufacturing floor, and escalates matters requiring department-level or Quality approval.
Responsibilities
- Supervise daily sterile manufacturing execution across formulation, component preparation, isolator filling, inspection, and device assembly.
- Convert the approved production schedule into daily work assignments and coordinate operator coverage, equipment readiness, materials, and training needs for the four-operator team.
- Provide direct people supervision, coaching, attendance oversight, performance feedback, and development support in accordance with company policy and in partnership with the Associate Director and Human Resources.
- Verify that operators are appropriately trained and qualified before independent task execution and promptly address or escalate qualification gaps.
- Lead daily tier meetings, shift handoffs, floor communications, and first-line escalation; coordinate routine execution with Quality, Engineering, Validation, MS&T/Technical Operations, Supply Chain, EHS, and Maintenance.
- Serve as the front-line operational point of contact for assigned manufacturing equipment and processes; escalate decisions requiring business-owner, technical-owner, or department-level authority.
- Support equipment commissioning, qualification, process validation, aseptic process simulations/media fills, technology transfer, and production-readiness activities.
- Review batch records, logbooks, forms, and electronic records for completeness, accuracy, contemporaneous documentation, and readiness for formal review.
- Maintain area and personnel inspection readiness and support Sterile Operations during internal audits and health authority inspections.
- Monitor daily safety, quality, delivery, training, and performance indicators; communicate emerging risks and recommend corrective actions to the Associate Director.
- Draft, revise, route, implement, and maintain assigned SOPs, work instructions, forms, batch records, protocols, reports, and other QMS documents under the applicable review and approval process.
- Initiate or support assigned deviations, investigations, CAPAs, change controls, risk assessments, effectiveness checks, and action items within authorized responsibility.
- Gather facts, establish clear event timelines, participate in root-cause analysis, recommend practical corrective and preventive actions, and track assigned commitments to completion.
- Ensure floor activities comply with approved procedures, cGMP, data integrity expectations, aseptic processing controls, contamination control requirements, and applicable company policies.
- Implement approved quality-system actions and procedural changes on the manufacturing floor and verify operator understanding and adherence.
- Partner with Quality and promptly escalate disposition-impacting events, environmental or personnel monitoring excursions, process anomalies, documentation concerns, and visual inspection defect trends.
- Maintain clear supervisory boundaries by escalating final product-disposition decisions, significant compliance risks, and changes requiring department-level or Quality approval.
Requirements
- Education: Bachelor’s degree in engineering, microbiology, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific or technical field preferred. An associate degree, technical credential, or equivalent combination of education and directly relevant experience may be considered.
- Experience: 5-7+ years of pharmaceutical or biotechnology manufacturing experience, preferably including sterile or aseptic operations
- for any list of duties/requirements/benefits, and
for prose. Thus:
About the role
... (position summary plus maybe mission/values?)
But we need to include the mission statement etc? It says "MannKind is committed to developing..." That's about company. Could be part of About the role. We'll include that as prose. Then Responsibilities: list of duties. We need to convert the bullet points (they are sentences separated by periods) into- . The duties list includes many sentences each starting with a verb. We'll split each sentence as a list item.
We need to ensure we preserve all details.
Let's extract the duties:
From "Essential Duties And Responsibilities" paragraph:
- Supervise daily sterile manufacturing execution across formulation, component preparation, isolator filling, inspection, and device assembly.
- Convert the approved production schedule into daily work assignments and coordinate operator coverage, equipment readiness, materials, and training needs for the four-operator team.
- Provide direct people supervision, coaching, attendance oversight, performance feedback, and development support in accordance with company policy and in partnership with the Associate Director and Human Resources.
- Verify that operators are appropriately trained and qualified before independent task execution and promptly address or escalate qualification gaps.
- Lead daily tier meetings, shift handoffs, floor communications, and first-line escalation; coordinate routine execution with Quality, Engineering, Validation, MS&T/Technical Operations, Supply Chain, EHS, and Maintenance.
- Serve as the front-line operational point of contact for assigned manufacturing equipment and processes; escalate decisions requiring business-owner, technical-owner, or department-level authority.
- Support equipment commissioning, qualification, process validation, aseptic process simulations/media fills, technology transfer, and production-readiness activities.
- Review batch records, logbooks, forms, and electronic records for completeness, accuracy, contemporaneous documentation, and readiness for formal review.
- Maintain area and personnel inspection readiness and support Sterile Operations during internal audits and health authority inspections.
- Monitor daily safety, quality, delivery, training, and performance indicators; communicate emerging risks and recommend corrective actions to the Associate Director.
That's 10 items.
Now Quality System And Compliance Responsibilities: This could be part of Responsibilities or separate? It's more specific. We could include under Responsibilities as additional list items. But we could also create a separate section? The instruction: Use headings only for those specific headings. We have only those headings allowed. So we must fit all content under those headings. We could put Quality System responsibilities under Responsibilities as well.
Thus Responsibilities list will include both sets.
Now Requirements: Education and Experience.
From Minimum Qualifications:
Education Bachelor’s degree in engineering, microbiology, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific or technical field preferred. An associate degree, technical credential, or equivalent combination of education and directly relevant experience may be considered.
Experience 5-7+ years of pharmaceutical or biotechnology manufacturing experience, preferably including sterile or aseptic operations, with 2+ years of demonstrated lead, supervisory, or people-leadership experience.
We can put these as
- .
Now Qualifications: Required Knowledge, Skills, And Abilities.
List items:
- Working knowledge of sterile drug product manufacturing, aseptic processing, contamination control, cleanroom behavior, EU GMP Annex 1, U.S. FDA 21 CFR Parts 210 and 211, and applicable visual inspection requirements, including USP and .
- Demonstrated ability to supervise personnel and coordinate production in a regulated pharmaceutical or biotechnology environment.
- Sound technical writing and investigation-support skills, including the ability to draft QMS content and provide clear, factual event documentation.
- Ability to interpret batch records, process data, equipment alarms, qualification documents, and production metrics and to escalate abnormal conditions appropriately.
- Strong communication, prioritization, conflict-resolution, coaching, problem-solving, and cross-functional coordination skills.
- Working knowledge of electronic document, training, manufacturing, or quality systems used in regulated operations.
- Ability to make timely floor-level decisions within approved procedures and clearly recognize matters requiring escalation to the Associate Director, Quality, or a designated system owner.
Note there is a trailing ", and ." after USP? The text: "including USP and ." seems truncated; we must preserve as is.
Now Physical And Work Environment Requirements: This could be part of Requirements or Qualifications? It's separate but we could include under Requirements as additional list items. But we already have Requirements for Education/Experience; we could add another subsection? But we only allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We could put Physical requirements under Requirements as well, or under Qualifications. Since we have both Requirements and Qualifications sections, we can allocate: Requirements = Education + Experience + Physical And Work Environment Requirements. Qualifications = Knowledge, Skills, Abilities.
Skills: Could be empty if we already covered skills in Qualifications. But we could create a Skills section if there are distinct skill statements not covered. However the Required Knowledge, Skills, And Abilities already includes skills. To avoid thin sections, we might omit Skills section.
Pay: we have Pay Range.
Schedule: we have shift.
Now we need to output only HTML fragment.
Let's craft:
About the role
MannKind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. We are on a mission to give people control of their health and the freedom to live life. At MannKind, our employees are our number one asset, and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background, thought and perspective is valued and respected. Our team is also energized by the company’s entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly. Our Values serve as the foundation of MannKind’s culture. They define who we are, how we act, and guide our interactions every day—both with each other and the customers we serve. At MannKind, you will work with people who are experts in their fields, see challenges as opportunities, are tenacious and push boundaries, bring creative and solutions-based thinking forward, and always believe in winning together. The Sterile Operations Supervisor reports to the Associate Director, Sterile Operations and provides hands-on, front-line leadership for the daily execution of sterile drug product manufacturing. The role directly supervises the operator team, coordinates shift activities, and ensures safe, compliant, and reliable execution across the complete process train. The Supervisor supports assigned quality system documents and events, implements approved requirements on the manufacturing floor, and escalates matters requiring department-level or Quality approval.
Responsibilities
- Supervise daily sterile manufacturing execution across formulation, component preparation, isolator filling, inspection, and device assembly.
- Convert the approved production schedule into daily work assignments and coordinate operator coverage, equipment readiness, materials, and training needs for the four-operator team.
- Provide direct people supervision, coaching, attendance oversight, performance feedback, and development support in accordance with company policy and in partnership with the Associate Director and Human Resources.
- Verify that operators are appropriately trained and qualified before independent task execution and promptly address or escalate qualification gaps.
- Lead daily tier meetings, shift handoffs, floor communications, and first-line escalation; coordinate routine execution with Quality, Engineering, Validation, MS&T/Technical Operations, Supply Chain, EHS, and Maintenance.
- Serve as the front-line operational point of contact for assigned manufacturing equipment and processes; escalate decisions requiring business-owner, technical-owner, or department-level authority.
- Support equipment commissioning, qualification, process validation, aseptic process simulations/media fills, technology transfer, and production-readiness activities.
- Review batch records, logbooks, forms, and electronic records for completeness, accuracy, contemporaneous documentation, and readiness for formal review.
- Maintain area and personnel inspection readiness and support Sterile Operations during internal audits and health authority inspections.
- Monitor daily safety, quality, delivery, training, and performance indicators; communicate emerging risks and recommend corrective actions to the Associate Director.
- Draft, revise, route, implement, and maintain assigned SOPs, work instructions, forms, batch records, protocols, reports, and other QMS documents under the applicable review and approval process.
- Initiate or support assigned deviations, investigations, CAPAs, change controls, risk assessments, effectiveness checks, and action items within authorized responsibility.
- Gather facts, establish clear event timelines, participate in root-cause analysis, recommend practical corrective and preventive actions, and track assigned commitments to completion.
- Ensure floor activities comply with approved procedures, cGMP, data integrity expectations, aseptic processing controls, contamination control requirements, and applicable company policies.
- Implement approved quality-system actions and procedural changes on the manufacturing floor and verify operator understanding and adherence.
- Partner with Quality and promptly escalate disposition-impacting events, environmental or personnel monitoring excursions, process anomalies, documentation concerns, and visual inspection defect trends.
- Maintain clear supervisory boundaries by escalating final product-disposition decisions, significant compliance risks, and changes requiring department-level or Quality approval.
Requirements
- Education: Bachelor’s degree in engineering, microbiology, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific or technical field preferred. An associate degree, technical credential, or equivalent combination of education and directly relevant experience may be considered.
- Experience: 5-7+ years of pharmaceutical or biotechnology manufacturing experience, preferably including sterile or aseptic operations
- .
Now Qualifications: Required Knowledge, Skills, And Abilities.
List items:
- Working knowledge of sterile drug product manufacturing, aseptic processing, contamination control, cleanroom behavior, EU GMP Annex 1, U.S. FDA 21 CFR Parts 210 and 211, and applicable visual inspection requirements, including USP and .
- Demonstrated ability to supervise personnel and coordinate production in a regulated pharmaceutical or biotechnology environment.
- Sound technical writing and investigation-support skills, including the ability to draft QMS content and provide clear, factual event documentation.
- Ability to interpret batch records, process data, equipment alarms, qualification documents, and production metrics and to escalate abnormal conditions appropriately.
- Strong communication, prioritization, conflict-resolution, coaching, problem-solving, and cross-functional coordination skills.
- Working knowledge of electronic document, training, manufacturing, or quality systems used in regulated operations.
- Ability to make timely floor-level decisions within approved procedures and clearly recognize matters requiring escalation to the Associate Director, Quality, or a designated system owner.
Note there is a trailing ", and ." after USP? The text: "including USP and ." seems truncated; we must preserve as is.
Now Physical And Work Environment Requirements: This could be part of Requirements or Qualifications? It's separate but we could include under Requirements as additional list items. But we already have Requirements for Education/Experience; we could add another subsection? But we only allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We could put Physical requirements under Requirements as well, or under Qualifications. Since we have both Requirements and Qualifications sections, we can allocate: Requirements = Education + Experience + Physical And Work Environment Requirements. Qualifications = Knowledge, Skills, Abilities.
Skills: Could be empty if we already covered skills in Qualifications. But we could create a Skills section if there are distinct skill statements not covered. However the Required Knowledge, Skills, And Abilities already includes skills. To avoid thin sections, we might omit Skills section.
Pay: we have Pay Range.
Schedule: we have shift.
Now we need to output only HTML fragment.
Let's craft:
- . The duties list includes many sentences each starting with a verb. We'll split each sentence as a list item.
We need to ensure we preserve all details.
Let's extract the duties:
From "Essential Duties And Responsibilities" paragraph:
- Supervise daily sterile manufacturing execution across formulation, component preparation, isolator filling, inspection, and device assembly.
- Convert the approved production schedule into daily work assignments and coordinate operator coverage, equipment readiness, materials, and training needs for the four-operator team.
- Provide direct people supervision, coaching, attendance oversight, performance feedback, and development support in accordance with company policy and in partnership with the Associate Director and Human Resources.
- Verify that operators are appropriately trained and qualified before independent task execution and promptly address or escalate qualification gaps.
- Lead daily tier meetings, shift handoffs, floor communications, and first-line escalation; coordinate routine execution with Quality, Engineering, Validation, MS&T/Technical Operations, Supply Chain, EHS, and Maintenance.
- Serve as the front-line operational point of contact for assigned manufacturing equipment and processes; escalate decisions requiring business-owner, technical-owner, or department-level authority.
- Support equipment commissioning, qualification, process validation, aseptic process simulations/media fills, technology transfer, and production-readiness activities.
- Review batch records, logbooks, forms, and electronic records for completeness, accuracy, contemporaneous documentation, and readiness for formal review.
- Maintain area and personnel inspection readiness and support Sterile Operations during internal audits and health authority inspections.
- Monitor daily safety, quality, delivery, training, and performance indicators; communicate emerging risks and recommend corrective actions to the Associate Director.
That's 10 items.
Now Quality System And Compliance Responsibilities: This could be part of Responsibilities or separate? It's more specific. We could include under Responsibilities as additional list items. But we could also create a separate section? The instruction: Use headings only for those specific headings. We have only those headings allowed. So we must fit all content under those headings. We could put Quality System responsibilities under Responsibilities as well.
Thus Responsibilities list will include both sets.
Now Requirements: Education and Experience.
From Minimum Qualifications:
Education Bachelor’s degree in engineering, microbiology, biochemistry, pharmaceutical sciences, biotechnology, or a related scientific or technical field preferred. An associate degree, technical credential, or equivalent combination of education and directly relevant experience may be considered.
Experience 5-7+ years of pharmaceutical or biotechnology manufacturing experience, preferably including sterile or aseptic operations, with 2+ years of demonstrated lead, supervisory, or people-leadership experience.
We can put these as