Job Description

Compensation/Notes:

• $65-$80/hr -- Exact compensation may vary based on several factors, including skills, experience, and education.
• Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Required Skills & Experience

• On the West Coast or willing to relocate for project. Expenses provided for those traveling including flight, lodging, meals; local candidates will not receive expenses
• 4+ years' experience leading Drug Product Technical Transfers B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering or other types of engineering.
• Involvement in sterile drug product technical transfers Experience in Sterile Manufacturing, STRONG preference in sterile filling (also called Aseptic) Technical Writing & Change Control

Job Description: One of our large pharmaceutical clients is actively hiring for a Technical Transfer Lead, specializing in drug product sterile filling, supporting the external manufacturing team. This person will be supporting tech transfers for vaccine and biologic drug products, specifically a liquid drug product tech transfer and traveling 3 weeks per month onsite at the CMO on the west coast. The travel will start in September / October and will be remote until then. The client is executing sterile drug product technical transfers and would need a Lead to support the program by authoring technical documentation and supporting technical development studies through protocol development, floor execution, sample submission, data analysis, and reporting. As needed, support may be required for routine commercial drug product production (change controls, data analysis, etc.). This candidate will take process designs, author protocols, and execute different studies at commercial scale. These studies may include but are not limited to mixing studies, fill line studies, engineering batches, etc. You will be hands on with manufacturing of filled vials or syringes and submitting product samples to labs for analysis. The Engineer will also help with data analysis and author reports based off their findings. The client currently uses Microsoft Office-based software and statistical analysis programs (JMP). You will be integrated into the project teams and involved in the transfer of sterile drug products for commercialization - such as manufacturing drugs at a larger scale, stability testing, drug development, and transfer into their final primary containers, such as vials or syringes, under controlled aseptic conditions. This role is 75% travel so ideally looking for local candidates.

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