Director, Technical Services

Simtra US LLC; Bloomington (IN); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Day One Benefits

401(k) Retirement Plan

Paid Time Off

Education Assistance

Employee Assistance Program

Long-Term Disability

Job summary

Simtra BioPharma Solutions (Simtra) in Bloomington, IN, seeks a Technical Services Director to lead sterile filling/packaging operations, drive technical transfer, validation and strategic planning for clinical and commercial products. You will liaise between customers and manufacturing, guiding multidisciplinary teams to ensure quality and regulatory adherence.

The role requires a strong background in aseptic processing, cross-functional leadership and a budget of over $10M, with travel up to

Qualifications

• Bachelor's Degree in a technical field (science or engineering) required.
• Minimum 10 years of experience in aseptic manufacturing operations.
• Minimum 8 years of technical management experience including cross-functional teams, resource and budget management and strategic development.
• Strong knowledge of aseptic processing and validation in a globally regulated industry (FDA, EMEA, PIC/S, Japan PMDA).
• Proficient with quality enterprise software systems; MS Word/Excel/Outlook experience.

Responsibilities

• Lead cross-functional teams in technical transfer, commercial product support, sterility 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 development and implementation of new processes requiring new technologies.
• Synthesize information from multiple disciplines to solve complex problems with innovative approaches.
• Develop and manage budget exceeding $10MM and ensure alignment with business needs.
• Approve product and process documentation, CAPAs, deviation investigations and change controls.
• Lead strategic planning, deployment, execution and after-action reviews for the site.
• Represent the site during regulatory inspections, client visits and internal audits.
• Collaborate with site Quality to drive improvements and risk reduction.

Education

Bachelor's Degree in technical discipline

Tools

Microsoft Word

Job description

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?

• 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.

The role:

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.

The 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[1]:

• 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

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.

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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