---
title: 'Director, Technical Services at Simtra BioPharma Solutions'
canonical: 'https://feeny.ai/job/director-technical-services-simtra-biopharma-solutions-bloomington-indiana-83n7qhvpnm4b'
type: 'job'
last_seen: '2026-09-12'
---

# Director, Technical Services at Simtra BioPharma Solutions

- **Company:** Simtra BioPharma Solutions
- **Location:** Bloomington Indiana, United States
- **Posted:** 2026-05-12
- **Last confirmed live:** 2026-09-12
- **Apply:** https://job-boards.greenhouse.io/simtrabps/jobs/5122862007

## 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? 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.

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

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.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  [https://simtra.com/privacy-policy/](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsimtra.com%2Fprivacy-policy%2F&data=05%7C02%7Ctelillard%40simtra.com%7C2a07b23ebad444facb3f08dd5108ca38%7C3e24d115ff1144459784a58e778309bd%7C0%7C0%7C638755820398709298%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=%2F%2BNVbYrMrzzt06QgaReGYHpah6Eu6lTB5aALlW2f%2F0w%3D&reserved=0)

## About Simtra BioPharma Solutions

## Company Overview
- **One-liner**: Simtra BioPharma Solutions is a leading contract development and manufacturing organization (CDMO) specializing exclusively in sterile injectable products for pharmaceutical and biopharmaceutical clients.
- **Entity Type**: Private (Contract Development and Manufacturing Organization)
- **Headquarters**: Bloomington, Indiana, United States (with a second major facility in Halle/Westfalen, Germany)
- **Founded**: Not publicly disclosed (the company references "decades of experience")
- **Founders**: Not publicly available

## Core Business
- **Primary industry**: Pharmaceutical contract development and manufacturing (CDMO) – sterile injectables
- **Target customers**: B2B – pharmaceutical and biopharmaceutical companies seeking development and commercial manufacturing of injectable drugs
- **Mission purpose**: “Make what matters” – delivering vital injectable products to patients worldwide with a focus on quality, safety, and compliance

## Products & Services
- **Formulation Development**: Customized development of parenteral formulations including liquid and lyophilized presentations.
- **Fill/Finish Operations**: Aseptic filling of liquid vials, lyophilized vials, and prefilled syringes.
- **Analytical Services**: Comprehensive analytical development and testing to support product release and stability.
- **Technology Transfer**: Seamless transfer of processes from client labs to Simtra’s cGMP facilities.
- **Lyophilization Cycle Optimization**: Expertise in freeze-drying cycle development and scale-up.
- **Specialized Containment**: Handling of cytotoxics, highly potent compounds, and other hazardous materials.
- **Global Regulatory Support**: Assistance with regulatory submissions and compliance for distribution in over 120 countries.
- **ADC Manufacturing Alliance**: Strategic partnership with MilliporeSigma (Merck KGaA) for end-to-end antibody-drug conjugate (ADC) development and manufacturing.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (private company)
- **Key Metric**: Not publicly available (annual revenue not reported); significant recent capital investments in capacity expansion
- **Notable Investors/Partners**: MilliporeSigma (Life Science business of Merck KGaA) – five-year strategic alliance for ADC manufacturing; Cook Group (seller of expansion property in Bloomington)
- **Growth Signals**:
  - Strategic purchase of a 65-acre property with 300,000+ sq ft available space near Bloomington facility for future expansion.
  - Completion of a new production manufacturing building at the Halle/Westfalen campus in Germany.
  - Active hiring with over 100 open positions across Engineering, Operations, Development, IT, and Quality.

## Competitive Advantages
- **Single-minded focus on sterile injectables**: Unlike broad-spectrum CDMOs, Simtra dedicates all expertise and facilities to injectable products.
- **Deep experience across drug categories**: Cytotoxics, highly potent compounds, biologics, vaccines, small molecules, and diluents.
- **Global cGMP compliance**: Both facilities operate under ISO 14001-certified manufacturing practices and strict regulatory standards.
- **Full-service integration**: From early development to commercial launch (lab through launch), offering a single point of accountability.
- **Track record of quality**: “Make it right the first time” culture with high standards for precision and transparency.

## Strategic Focus
- **Capacity expansion**: Aggressive investments in both U.S. (Bloomington) and German (Halle) sites to meet growing demand for injectable manufacturing.
- **End-to-end service expansion**: Enhancing development and pre-commercial services to shorten timelines and streamline drug launch.
- **Strategic alliances**: Leveraging the MilliporeSigma partnership to capture high-growth ADC and bioconjugate market.
- **Operational excellence**: Continuing to invest in state-of-the-art equipment and cross-site knowledge sharing.

## Why Work Here
- **Culture**: Values-driven workplace built around four pillars: Make It Right, Make It Together, Make It Happen, Make It Count. Emphasis on quality, integrity, collaboration, and patient impact.
- **Meaningful work**: Employees directly contribute to producing life-changing medicines and improving patient health.
- **Growth opportunities**: The company encourages a growth mindset, skill development, and career progression. Many roles offer hands-on involvement in complex manufacturing processes.
- **Remote/hybrid policy**: Some positions are remote or hybrid-eligible (e.g., Senior Recruiter in Germany with remote option, Senior Quality Systems Application Analyst remote in US). Most engineering and operations roles are on-site in Bloomington or Halle.
- **Diverse workforce**: Multiple locations and international collaboration create an inclusive team environment.
- **Benefits**: Not explicitly detailed in available sources, but the company promotes well-being and community impact as core employee value propositions.

## Sources
1. [Simtra BioPharma Solutions – Home](https://simtra.com/)
2. [Simtra – What We Do](https://simtra.com/what-we-do/)
3. [Simtra – Open Positions (Greenhouse)](http://job-boards.greenhouse.io/simtrabps)
4. [Simtra – Careers / Open Positions](https://simtra.com/careers/open-positions/)
5. [Simtra – Our Values](https://simtra.com/who-we-are/our-values/)

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