Supervisor, Manufacturing (2nd Shift 2:00pm - 10:30pm, Mon-Fri) at Mannkind

Danbury, Connecticut, United States -

Full Time

Start Date

Immediate

Expiry Date

29 Sep, 26

Salary

60.6

Posted On

01 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

cGMP Manufacturing, Staff Supervision, SOP Authoring, Batch Record Management, Deviation Investigation, Pharmaceutical Quality Standards, Process Technology, Production Scheduling, Clean Room Operations, Regulatory Compliance, Scale-up Processes, Troubleshooting

Industry

Pharmaceutical Manufacturing

Description

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. Position Summary: Supervises downstream related activities and staff responsible for cGMP drug product manufacturing. These responsibilities include but are not limited to the supervision of bulk and fill/pack manufacturing shifts, scale-up of processes, innovating novel approaches to improve production efficiency, scheduling of development activities at the commercial scale, supervision of cGMP operations, troubleshooting production challenges, hands on operations during commercial manufacturing batches, and assessing product performance. Executes against and authors, reviews, and approves various cGMP documents such as standard operating procedures, batch records, deviations, process descriptions, validation protocols, and development protocols / reports as required. Collaborates with Quality Assurance, Quality Control, Manufacturing Technical Services, Facilities Engineering, Formulation Research, Process Technology and Validations. Work Schedule is 2nd shift: 2:00pm to 10:30pm, Monday through Friday. 10% Shift Differential. Essential duties and key job responsibilities and essential functions: * Supervise the manufacturing floor/line operations of bulk and semi-finished drug product * Supervise / Coordinate Commercial Manufacturing support groups * Supervise departmental activities in order to maintain Commercial Manufacturing Clean Room and Potent Compound Facility Areas including participation and overseeing manufacturing operations * Supervise off-shifts, PTOs and vacations coverage * Train new manufacturing associates on bulk and fill/pack manufacturing processes * Author and revise Standard Operating Procedures * Author and revise Master Batch records * Investigate and complete manufacturing deviations * Cover work shifts of other manufacturing supervisors on vacation or PTO, as necessary. * Ensure that manufacturing is conducted according to domestic and foreign regulatory agency requirements and MannKind procedures * Coordinate the development activities of existing and new product platforms without significant impact to production schedule * Short term planning of bulk and fill/pack manufacturing activities to support master production schedule * Responsible for observing all Company, Health, Safety and Environmental guidelines. Duties and responsibilities are not limited to the work listed above and may include other assignments Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any. * High school diploma with 10+ years related manufacturing / supervisory experience or AA degree with 8 years or BS degree with 8 years or BS degree with 4 years * High level of knowledge with process technologies, equipment, and manufacturing of pharmaceutical drug products. * Strong knowledge of pharmaceutical quality standards. * Experience writing and implementing SOPs in a GMP environment. * Must be willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift. * Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek® jumpsuit).

Responsibilities

Supervise downstream cGMP drug product manufacturing activities, including bulk and fill/pack operations and staff management. Responsible for authoring and reviewing critical GMP documentation and coordinating with cross-functional quality and engineering teams.