Technical Services, Sr. Manager

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 Technical Services (TS) Senior Manager is a part of the 4-person Leadership Team along with the Sr. Engineering Manager, Sr. Manufacturing Manager and the Sr. Quality Manager. This role will manage a team of TS professionals in an aseptic pharmaceutical manufacturing facility. The team is responsible for creating and owning Master Batch Records (MBR) and day-to-day technical support of the aseptic manufacturing operations, including planning and performing technical studies and projects. This position reports to the Director of Technical Services and 100% onsite at the Bloomington facility.

The responsibilities:

Facility Leadership:

• Work alongside Manufacturing, Engineering and Quality cell managers to fully own the performance for the operations in the Building Cell, including but not limited to:
  • Quality performance (batch release, non-conformance / right first time, corrective & preventive actions)
  • Manufacturing output (batch execution, run rates
• Serve as the primary technical resource for issue resolution during manufacturing operations
• Drive creative technical improvements for the Building Cell leadership team
  • Ensure the TS team is aligned to support the Building Cell goals and performance
  • Fully engaged in initiatives across TS functions for the Building Cell (engineering batches, pre-PPQ [process performance qualification] demos, PPQs, CCOQs for new equipment, TS studies to drive improvements or generate data for investigations, SAV [sterility assurance validations], cleaning validations, etc.
• Engage with the TS Building Cell teams (SAV, Technical Transfer, Process Validation, and CSV [Computer System Validation] and facilitate getting studies run, as applicable
• Work with Manufacturing, Engineering, and Quality to quickly resolve manufacturing issues

Technical Services (TS) Team Leadership:

• Manage and lead TS teams that own the master batch records (MBRs) and the TS floor support roles
  o Effectively operate in and mentor direct reports to lead cross-functional teams to complete process improvements
  o Maintain and develop direct reports to be SME (Subject Matter Expert) for technical processes applicable for the Building Cell
• Ensure timely and thorough investigation of manufacturing anomalies to identify batch impact, root causes, corrective/preventative actions, and approval of investigation findings and conclusions
• Provide technical support during client and regulatory audits (individually or team) and be a technical resource for plant initiative
• Approve technical study design and final study reports, e.g. MBR, PV protocols and summaries, TSS protocols and summaries, etc.
• Strategically set goals for team to support site goals and metrics
• Develops, coaches, mentors, and trains employees on necessary skills, including technical writing skills and client interfacing support skills
• Facilitates career progression of direct reports

Required qualifications:

• BS degree, preferably in science or engineering discipline
• 8+ years experience in pharmaceutical/cGMP environment
• 5+ years of supervisory/leadership experience
• Experience working with cross-functional groups (i.e., engineering, manufacturing, and quality)
• Advanced proficiency in MS Office Suite (Word, Excel, and Outlook)
• Demonstrated ability to use enterprise software (Veeva, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to wear applicable personal protective equipment
• Must be able to gown for Grade C/D environments

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
  • 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
• Additional Benefits
  • 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 12/31/25

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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