Simtra BioPharma Solutions · 1 month ago
Sr. Manager, Aseptic Operations
Bloomington, Indiana, United States
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies. The Sr. Manager of Aseptic Operations is responsible for strategic leadership of the operations organization in the Aseptic Operations Cell, ensuring compliance with cGMP regulations and leading the team to achieve manufacturing goals.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
As the Operations leader within the Cell Leadership Team, the Sr. Manager of Aseptic Operations has accountability for successful execution of the manufacturing plan to deliver on the site’s two primary KPIs: Right First Time and On Time Delivery
Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds
Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity
Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Must believe in 6S…it is the foundation of quality and a lean enterprise. Setting the example is not the only thing in influencing others, it is the main thing
Defines value for products/services from a customer perspective; focuses and aligns all actions of building leadership team and its team members to create value for the customer
Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives
Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”
Leads / partners with Quality, Technical Services, and Engineering & Maintenance leaders to either author, review and / or approve deviations and drive timely closure to meet client delivery dates
Approves SOP’s, validations, and protocols in a timely manner
Partners with client teams to manage client projects and host client audits
Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services
Develops the organization’s annual operating budget and maintains expenses within the plan
Regularly interacts with senior management and executive leadership team members on matters concerning performance against the business plan
Interfaces with the other manufacturing operations management staff/customers to ensure our quality commitments are met
Qualification
Required
Bachelor's degree required
Minimum 8 years' experience in all aspects of the aseptic manufacturing process preferred
Must have knowledge of GMPs and worldwide regulatory agency guidelines
Minimum 5 years in a leadership role
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, etc.)
Ability to stand for extended periods of time
Physical coordination/flexibility to allow gowning for clean room environments
Utilize 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
Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Must be able to gown qualify for Grade A/B areas (filling)
Position may require sitting for long hours
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
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