Simtra BioPharma Solutions · 4 months ago
Manufacturing Supervisor, Weekend AM
Bloomington, Indiana, United States
Full-time
Onsite
Entry, Mid Level
2+ years expSimtra BioPharma Solutions is a leading Contract Development Manufacturing Organization specializing in sterile injectable products. The Supervisor, Aseptic Operations will lead a team in manufacturing sterile injectable drug products, ensuring compliance with cGMP and overseeing daily production activities.
BiopharmaManufacturingMedicalPharmaceutical
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
Qualification
Required
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.)
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)
Preferred
Bachelor's Degree in a science, engineering, or business discipline strongly preferred
Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
Short and Long-Term Disability 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
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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
Inside INdiana Business
2025-09-23
Company data provided by crunchbase