Manufacturing Supervisor, Weekend PM
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Key skills for this role
Key Skills for This Role
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The role
The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in manufacturing of sterile injectable drug products.
The Supervisor, Aseptic Operations provides decision making and oversight to ensure compliance to all standard operating procedures and batch records. They must communicate effectively with Operations support departments (Quality, Technical Services, Engineering & Maintenance, etc.), multiple levels of management, and other customer support departments. The Supervisor, Aseptic Operations builds an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.
Its responsibilities
- Understand, follow, coach, and lead their teams to execute production activities in accordance with current Good Manufacturing Practices (cGMP).
- Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
- Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.
- Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities in order to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.
- Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
- Implement and support training programs designed 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 in order to routinely evaluate operational efficiency and quality. Implement changes as needed based on assessments.
- Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
- Resolve technical, material and cGMP problems that may impact project deadlines.
- Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.
- Obtain qualification to perform select critical operation processes.
- Represent the company during audits and inspections.
Desirable qualifications
- Bachelor's Degree in a science, engineering, or business discipline strongly preferred
- High School diploma or GED required
- Minimum 2 years of manufacturing or operations support experience required
- Minimum 1 year leadership experience required
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Microsoft Dynamics, Veeva, PowerBI, Trackwise, etc.)
Physical / safety requirements
- Ability to stand or sit for extended periods of time
- Ability to lift up to 50 pounds
- Ability to push/pull heavy wheeled objects (i.e.: tanks, carts, pallet jacks, etc.)
- Must be able to perform overhead work (i.e.: sanitizing walls and ceilings)
- 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)
- In return, you’ll be eligible for [1] :
- Day One Benefits Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance Spouse Life Insurance Child Life Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program Paid Holidays Paid Time Off Paid Parental Leave and more Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance Spouse Life Insurance Child Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program Paid Holidays Paid Time Off Paid Parental Leave and more
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits Short and Long-Term Disability Insurance Voluntary Insurance Benefits Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more Onsite Campus Amenities Workout Facility Cafeteria Credit Union
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities Workout Facility Cafeteria Credit Union
- Workout Facility
- Cafeteria
- Credit Union
- [1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates 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.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
About Simtra BioPharma Solutions
Independent CDMO developing and manufacturing sterile injectables for pharmaceutical and biotechnology companies.
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