Director, Technical Services

Simtrabps; Bloomington (IN); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Paid Time Off

Education Assistance Program

Employee Assistance Program

Job summary

Simtrabps in Bloomington, Indiana is seeking a Technical Services Director to oversee the development and execution of clinical and commercial technical transfer operations. This leadership role includes managing cross-functional teams and ensuring compliance with global regulatory requirements.

The ideal candidate will possess a Bachelor’s Degree and extensive experience in aseptic manufacturing and technical management, with a strong focus on budget management and strategic planning. This position offers a comprehensive benefits package including medical, dental, and retirement options.

Qualifications

• Minimum 10 years of experience in aseptic manufacturing operations.
• Minimum 8 years of technical management experience.
• Strong knowledge of aseptic processing and validation.

Responsibilities

• Lead cross-functional teams in technical transfer and validation operations.
• Establish validation strategies in compliance with regulatory requirements.
• Develop and implement new processes requiring new technologies.

Skills

Aseptic manufacturing operations

Technical management

Budget management

Cross-functional leadership

Education

Bachelor’s Degree in technical discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Technical Services Director

The Bloomington facility is a full-service contract manufacturing plant providing formulation, aseptic filling and finishing services. The Technical Services Director is a member of the plant senior leadership team and is responsible for the development, coordination and execution of clinical and commercial technical transfer and validation operations for syringe and vial filling/packaging activities. This includes providing guidance and technical expertise to multiple disciplines and serving as the technical liaison between the customer and manufacturing. The Director is also responsible for the strategic planning of the department. This position reports to the Site Director.

Responsibilities

• Site Director delegate
• Lead cross-functional teams in technical transfer, commercial product support, sterility assurance validation, process validation, risk management, cleaning validation, inspection/packaging validation, and computer systems validation for filling and packaging operations
• Establish and deploy validation strategies in compliance with global regulatory requirements
• Direct the development and implementation of new processes requiring new technologies
• Understand and integrate information from more than one discipline and apply to complex problems requiring innovative techniques
• Budget development (>$10MM) and maintenance to meet business needs
• Responsible for final approval on product/process documentation, including CAPAs, deviation investigations and change controls
• Responsible for strategic planning, deployment, execution and after-action reviews
• Represent the site during regulatory inspections, client visits, and internal audits
• Collaborate with site Quality to drive improvements and risk reduction

Required qualifications

• Bachelor’s Degree in technical discipline required, preferably in science or engineering
• Minimum 10 years of experience in aseptic manufacturing operations required
• Minimum 8 years of technical management experience including cross-functional teams, resource and budget management and strategic development experience
• Strong knowledge of aseptic processing and validation in a globally regulated industry (FDA, EMEA, PIC/S, Japan PMDA, etc.)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use quality enterprise software systems

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.
• Global travel may be required (10%)

In return, you’ll be eligible for

• 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

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