Sr. Manager, Aseptic Operations

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.


Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

This role:

The Sr. Manager of Aseptic Operations has responsibility for all operations occurring within their respective Aseptic Operations Cell at the Bloomington, Indiana site. As a member of the Cell Leadership Team alongside their Quality, Engineering & Maintenance, and Technical Services Sr. Manager counterparts, the Sr. Manager of Aseptic Operations has responsibility for strategic leadership of the operations organization in their respective Aseptic Operations Cell, reporting to the Director of Aseptic Operations. The Sr. Manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Sr. Manager, Aseptic Operations creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

Essential Duties and 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

Job Requirements (Education and Experience ):

• 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.)

Physical / Safety Requirements:

• 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

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
• 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

[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.

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