Simtra BioPharma Solutions
pharmaceutical
Director,TechnicalServices
Neural analysis suggests this role is
optimal for Director candidates.
“Director, Technical Services at Simtra BioPharma Solutions. Skills: technical transfer, validation operations, aseptic manufacturing, technical management, strategic planning. development, coordination and execution of clinical and commercial technical transfer and validation operations for syringe and vial filling/packaging activities. providing guidance and technical expertise to multiple disciplines”
What You'll Achieve.
exceeding our expectations and those of our customers; fulfilling our commitments to the customer, their patients, and our team members; knowing the impact we make; improve patient health; drive improvements and risk reduction
Industry & Context.
solve problems in new ways; apply to complex problems requiring innovative techniques
overtime work, including nights and weekends, Use of hands and fingers to manipulate office equipment, 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%)
What They're Looking For.
Must Have
Bachelor's Degree in technical discipline, 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 experience, 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
What You'll Do.
coordination and execution of clinical and commercial technical transfer and validation operations for syringe and vial filling/packaging activities
providing guidance and technical expertise to multiple disciplines
serving as the technical liaison between the customer and manufacturing
strategic planning of the department
Lead cross-functional teams in technical transfer
commercial product support
sterility assurance 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
deviation investigations and change controls
Responsible for strategic planning
execution and after-action reviews
Represent the site during regulatory inspections
Collaborate with site Quality to drive improvements and risk reduction
How You'll Work.
Team & Collaboration
Lead cross-functional teams; work as one; tapping into our unique strengths across teams; Collaborate with site Quality
Communication Scope
technical liaison between the customer and manufacturing
Process & Methodology
technical transfer, validation operations, strategic planning, deployment, execution, after-action reviews
Full 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
Applying for this Director, Technical Services role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Simtra BioPharma Solutions?
Real rants from real employees. Read before you apply.