Simtra BioPharma Solutions
Director, Technical Services
Bloomington, Indiana, United States · Director
Sponsorship not specifiedDetected 12 days ago
ExcelGMPFDA RegulatoryLeadershipMicrosoft Office
About the role
- The Bloomington facility is a full-service contract manufacturing plant providing formulation, aseptic filling and finishing services.
- 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.
Responsibilities
- 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
- Collaborate with site Quality to drive improvements and risk reduction
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- 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
- Use of hands and fingers to manipulate office equipment is required
- Ability to meet Grade C gowning requirements.
- Global travel may be required (10%)
Skills
- Direct the development and implementation of new processes requiring new technologies
Benefits
- 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.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
Company info
- 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.
Equal 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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