Associate Manufacturing Technology Specialist

Organization
Cook Pharmica
Job Location
Bloomington, IN
Job Description

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 

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