For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement.  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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

Your role at Simtra BioPharma Solutions:

The Manufacturing Manager is the leader of the Building Leadership Team and reports directly to the Director of Operations.  The 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 Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

 

What you'll do:

  • 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. 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 and technical services leaders to either author, review and / or approve exceptions and drive timely closure to meet client delivery dates.
  • Approves SOP’s, validations, and protocols in a timely manner.
  • Partners with client teams to support client projects and client audits.
  • Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
  • Formulates long and short-range planning for functional area using the strategy deployment principles of Simtra's Enterprise Management System.
  • Develops the organization’s annual operating budget and maintains expenses within the plan.
  • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
  • Interfaces with the other manufacturing operations management staff/customers to ensure our quality commitments are met.

 

What you'll bring:

  • Bachelor’s degree required, preferably in scientific or engineering discipline
  • Minimum 8 years experience in all aspects of the aseptic manufacturing process.
  • Must have knowledge of GMPs and worldwide regulatory agency guidelines
  • Minimum 5 years in a leadership role.
  • Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, 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

 

 

#IND-USOPS

 

Equal Employment Opportunity

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Reasonable Accommodations

Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

 

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