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.

The Technical Services Sr. Manager leads the team of technical SMEs responsible for the transfer/onboarding of sterile, injectable, pharmaceutical products. Technical Transfer is responsible for developing, implementing, and managing product transfer programs and process validation processes to ensure products meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position reports to the Director, Technical Services

What you'll be doing:

• The Sr. Manager is responsible for managing a team of salaried exempt employees responsible for transferring new client products into the facility as well as managing a team of floor support Technical Services personnel covering 3 shifts.
• Responsible for coaching and facilitating development of team members.
• Must employ structured operational mechanisms to drive departmental deliverables.
• The Technical Transfer Team's Primary Duties include:
  • Transfer new client products into the BPS operation: This includes working directly with the Client team and internal BPS Process Validation, Technical, Quality and Manufacturing to design the manufacturing process, creation of Technical Transfer plans, co-creator duties for the Process Performance Qualification (PPQ) approach, responsible for creating the PPQ master batch records, co-owning the PPQ execution, and creating Product Development Summary Reports (PPQ related).
  • The positions are the front-line client facing positions with the Client Technical, Operations and Quality personnel.
  • Throughout the product lifecycle, the Tech. Transfer professionals remain technical subject matter experts for the product.
  • These positions, including the Sr. Manager, are routinely involved with regulatory inspections.
  • These positions regularly perform non-conformance investigations (NCR), and own corrective & preventive actions (CAPA) and change control management initiatives (CCM).
• The floor support team's primary duties are:
  • Support the manufacturing operations (aid in process troubleshooting, aid in additional batch record pages, etc.)
  • Create, support and conduct technical studies
  • Support demonstration batches, pre-PPQ batches, & PPQ batches
  • Primary performers of filter integrity testing troubleshooting (a direct batch release activity).
  • Regularly own NCR investigations, CAPAs and CCM tasks.
• Works closely with Sales and Program Management to evaluate potential new client projects for fit within the facility
• Interacts with potential clients to define product transfer activities (technical capability/feasibility, component and equipment options, risk assessments, constraint analysis) and to understand customer regulatory requirements.
• Manages the creation and dissemination of technical documents for use by assessment committees and technical resources.
• Evaluates novel technology opportunities
• Directs or participates in: performing technical failure analysis of processes / product not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce product / process variability.
• Applies statistical analysis and design of experimental approaches to process development activities.
• Reviews and approves NCRs to ensure a thorough investigation, root cause analysis and corrective/preventive action.

What you'll bring:

• Bachelor's degree required, preferably in science or engineering
• 8 years related experience in Technical Operations, product transfer and validation within pharmaceutical or biotech
• 3 years experience with managing/leading/supervising personnel
• Strong understanding and practical application of ICH Risk Management, Process Design (Stage1), and Process Performance Qualification (Stage 2) principles
• Strong leadership and organization skills
• 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:

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Ability to meet Grade C gowning requirements

#IND-USOPS

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Simtra is 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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Reasonable Accommodations

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