Sr. Manager, Aseptic Operations

Simtra BioPharma Solutions•Bloomington, IN

30d•Onsite

About The Position

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.

Requirements

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

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