Enter a job title or keyword
Supervisor, Sterile Operations (M-F, 7am 330pm)
Job Location:
Job Location:
Danbury, CT - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
29 September 2026 (6 days ago)
Posted:
Application Deadline:
29 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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 companys entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly.
Our Values serve as the foundation of MannKinds culture. They define who we are how we act and guide our interactions every dayboth 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.
Position Summary
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. *This is a 1st Shift role; Monday to Friday from 7:00am to 3:30pm.*
Essential Duties and 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 HRBP.
- 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.
Quality System and Compliance Responsibilities
- 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.
Minimum Qualifications
Education | Bachelors 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. |
Required Knowledge Skills and Abilities
- 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 <790> and <1790>.
- 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.
Physical and Work Environment Requirements
- Ability to work in classified cleanroom environments and wear required gowning and personal protective equipment for extended periods.
- Ability to stand walk reach bend and perform repetitive tasks for extended periods.
- Ability to lift and move materials within company-defined safe-lifting limits with assistance or mechanical aids when required.
- Ability to pass a visual acuity check for qualification of visual inspection to meet 20/20 near vision (natural or corrected) and demonstrate normal color perception via a standardized occupational color vision screening.
- Ability to work around cleaning agents sanitizers disinfectants and VHP-controlled equipment in accordance with approved safety procedures.
- Ability to work the assigned schedule and modified schedules during qualifications media fills campaigns shutdowns or business-critical events.
The duties and responsibilities described above are not intended to be an exhaustive list. Additional duties may be assigned based on business needs. Reasonable accommodation may be made to enable qualified individuals to perform the essential functions of the position.
Required Experience:
Manager
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
