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Manufacturing Senior Supervisor
1 month ago
About the Role:
The Senior Supervisor, Manufacturing is a key member of the Manufacturing Leadership Team at Simtra BioPharma Solutions. This role provides direct support to Manufacturing personnel and is responsible for the production of injectable drug products.
Key Responsibilities:
- Provide guidance, support, direction, and leadership to Manufacturing personnel during daily operations.
- Interview, hire, mentor, and develop staff, conducting annual performance reviews and setting performance objectives and development plans.
- Supervise day-to-day production, scheduling, staffing, material management, compliance, training, and auditing activities to meet customer requirements, including deadlines and quality standards.
- Review, approve, and manage documentation for batch and system records, assist in the release of product for distribution, and assist in meeting product release time goals.
- Implement and support training programs to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.
- Develop and implement performance measurement and internal auditing programs to evaluate operation efficiency and quality, implementing changes as needed based on assessments.
- Lead technical reviews, investigations, and process improvement projects, providing manufacturing input into integration and validation of new equipment and processes.
- Resolve technical, material, and cGMP problems that may impact project deadlines, providing guidance and troubleshooting assistance as needed during a deviation in the process.
Requirements:
- HS Diploma/GED required, Bachelor's degree preferred.
- Minimum 3 years of manufacturing experience required.
- Minimum 4 years leadership-related experience required.
- In-depth knowledge of related pharmaceutical manufacturing equipment and processes preferred.
- Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred.
- Computer proficiency in Microsoft Word, Excel, and Outlook, and the ability to use enterprise software (examples include: JDE, BPLM, Maximo, Trackwise, Microsoft Dynamics, etc.).
Physical/Safety Requirements:
- Ability to stand or sit for extended periods.
- Ability to lift up to 50 pounds.
- Ability to push/pull heavy wheeled objects (e.g., tanks, carts, pallet jacks, etc.).
- Physical coordination/flexibility to allow gowning for clean room environments.
- Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat-resistant wear, and hearing protection.
- Dexterity and physical condition to perform some level of repetitive motion tasks.
- Ability to wear respirator usage when product or task requires.
- Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable).
- Use of hands and fingers to manipulate office equipment is required.
- Must be able to gown qualify for Grade A/B areas (filling).
Equal Employment Opportunity:
Simtra is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.