Associate Manufacturing Technology Specialist
Overview
People are at the center of who we are and what we do.
Are you seeking…
– A culture defined with the help of your voice?
– Recognition for your talent and continued growth opportunity?
– Upfront tuition assistance (eligible day one of employment)?
– A dynamic benefits package with access to employee health clinic?
– A place where what you do impacts lives?
The Associate Manufacturing Technology Specialist's primary responsibility is to scale up and transfer processes into full-scale manufacturing based on data provided by Process Development or by Client.
Requirements:
Responsibilities
– Select appropriate equipment and single-use components to perform process at large scale
– Develop technical documentation (e.g., Process Flow Diagrams, Process Descriptions) to describe operation of the process at large scale
– Meet with Process Development or client technical team to understand bench and pilot-scale data
– Develop in-process test strategy for manufacturing process at large scale
– Write or direct the writing of GMP manufacturing documentation, including Process Batch Records, Buffer and Media Formulation records, Sample Plans, Bills of Materials
– Provide technical training as necessary to operators
– Provide on-the-floor oversight of the manufacturing process, as necessary
– Interact with client technical representatives, including Person in Plant observers on manufacturing floor
– Monitor process data, identify trends, present data, and propose action as necessary
– Perform technical troubleshooting and investigations of process issues
– Perform and document formal deviation investigations as needed
– Write or direct the writing of post run reports (e.g., Manufacturing Campaign Report)
– Provide technical guidance and oversight to the validation group to support Process Validation and Continued Process Verification
– Work with Process Development and Process Engineering to assess and implement new technology in large scale manufacturing
– Mentor junior level Scientists and Engineers, co-ops and interns
– Maintain relationships with process technology vendors to understand new technology development
Qualifications
– Bachelor's degree in Science
– Master's degree preferred
– 0+ years of experience
About Cook Pharmica
At Cook Pharmica, our business thrives on the success of our people. As an award-winning contract development and manufacturing organization, we are responsible for assisting biopharmaceutical companies in developing and producing lifesaving drugs. We maintain a simple goal: to deliver quality products in a timely manner. To do this effectively, Cook Pharmica has invested heavily in its facility, people, and processes.
Cook Pharmica takes great pride in offering employees a benefits package that includes:
– Diverse, inclusive culture
– Competitive salary with quarterly bonus potential
– 401(k) retirement savings plan with company match
– Profit sharing
– Educational assistance/reimbursement
– Paid time off
– Medical, dental, and vision insurance
– Life insurance
– Parental leave
– Flexible spending account
– On-site fitness center and wellness programs
– Excellent on-site cafeteria
– Employee discount programs
