Senior Technical Transfer Associate

Job Description

Simtra BioPharma Solutions is seeking a Senior Technical Transfer Associate to join their team in Bloomington, Indiana. This role is crucial for the technical onboarding and process development of new drug product projects. The Senior Associate will collaborate with cross-functional teams, including Program Management, Sales, Supply Chain, Process Validation, and R&D, to ensure successful project transfers to Simtra.Responsibilities include:

• Leading onboarding and process development for new drug products.
• Creating technical transfer documents (Technical Transfer Plan, Process Development studies, Demonstration batch records, PPQ master batch record).
• Participating in PPQ strategy and protocol development with Process Validation.
• Providing technical support to daily manufacturing operations.
• Leading process improvement activities and NCR investigations.
• Managing Change Control and Fill Volume Dosing Qualification documentation.
• Representing Simtra in regulatory, client, and internal audits.
• Participating in client calls and on-site visits.
• Serving as an SOP owner and process SME.
• Mentoring new hires.

Qualifications include:

• BS degree in a science or engineering field.
• 7+ years of pharmaceutical manufacturing experience.
• 3+ years of Technical Transfer/Process Development experience.
• In-depth knowledge of systems and equipment.
• Expertise in aseptic processing, sterile filtration, and Process Validation.
• Proficiency in Microsoft Office Suite and enterprise software.

Simtra BioPharma Solutions offers:

• Day One Benefits (Medical, Dental, Flexible Spending Accounts, Life Insurance, Disability Insurance).
• 401(k) Retirement Savings Plan with Company Match.
• Time Off Program (Paid Holidays, Paid Time Off, Paid Parental Leave).
• Adoption Reimbursement Program and Education Assistance Program.
• Employee Assistance Program and Community/Volunteer Service Program.
• Voluntary Insurance Benefits (Vision, Accident, Critical Illness, Identity Theft Protection).
• Onsite Campus Amenities (Workout Facility, Cafeteria, Credit Union).