Process Specialist – Clinical Manufacturing

Simtra BioPharma Solutions (Simtra) is a Contract Development Manufacturing Organization (CDMO) specializing in sterile injectable products. They are seeking a Process Specialist – Clinical Manufacturing to support clinical production line operations, including equipment operation, team leadership, and product transfer. This role involves technical support, process improvement, and ensuring compliance with industry standards.

Requirements

• Develop expertise in filling line processes.
• Become SME across multiple manufacturing areas (Preparation, Filling, Formulation, Capping, and Lyophilization).
• Delegate and coordinate scheduled activities.
• Collaborate closely with Quality and ensure operational flexibility.
• Support product technical transfers.

Benefits

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Onsite Campus Amenities
• Professional Development