Associate Production Scientist - B Shift
About The Position
Employee is responsible to adhere to the GMP requirements defined within 21 CFR parts 210 &211, 820, ICH Q7, Safety standards set under ISO 14001 & 45001. This position primarily involves the safe and efficient manufacturing of active pharmaceutical ingredients (API’s) according to current Good Manufacturing Practice (cGMP) requirements. The role of Associate Production Scientist is a lab-based role primarily focused on supporting and executing activities in the manufacturing environment, including but not limited to: executing existing production procedures, updating supporting documents, maintaining the safety and quality of the manufacturing process, and other production tasks as directed. B shift is Thursday – Sunday 6:30am – 7:00pm, then Friday – Sunday 6:30am – 7:00pm. Demonstrate proper lab safety practices and comply with FDA, OSHA, EPA, DNR, DOT, and other regulatory guidelines. Operate as a primary operator in multiple cGMP production areas, including Kilo Labs, and train secondary operators to achieve primary status. Draft preliminary reports on deviations from procedures, identifying potential contributing factors. Utilize and update written procedures, including operation and batch records, with assistance from supervisors. Mentor new employees through technical and on-the-job training, fostering a collaborative team environment. Maintain safety and cleanliness in production areas, focusing on potent compound handling techniques and proper PPE usage. Communicate production status effectively using shift pass-off tools and computer systems, while addressing safety and process issues promptly. Take ownership of departmental responsibilities, providing support through additional tasks as directed by leadership.
Requirements
- Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering, or other Life Science discipline.
- 1+ years of regulated pharmaceutical or chemical production manufacturing experience in an academic or professional setting.
Nice To Haves
- Ability to read and understand written protocols.
- Basic computer literacy (Microsoft Office and Outlook tools, Electronic Document Management Systems, etc.).
- Effective oral and written communication skills.
- Basic mathematical skills.
- Possess a high degree of motivation and self-starter attitude.
- Ability to multi-task while paying close attention to detail.
Responsibilities
- Adhere to GMP requirements
- Safe and efficient manufacturing of active pharmaceutical ingredients (API’s)
- Executing existing production procedures
- Updating supporting documents
- Maintaining the safety and quality of the manufacturing process
- Demonstrate proper lab safety practices and comply with FDA, OSHA, EPA, DNR, DOT, and other regulatory guidelines.
- Operate as a primary operator in multiple cGMP production areas, including Kilo Labs, and train secondary operators to achieve primary status.
- Draft preliminary reports on deviations from procedures, identifying potential contributing factors.
- Utilize and update written procedures, including operation and batch records, with assistance from supervisors.
- Mentor new employees through technical and on-the-job training, fostering a collaborative team environment.
- Maintain safety and cleanliness in production areas, focusing on potent compound handling techniques and proper PPE usage.
- Communicate production status effectively using shift pass-off tools and computer systems, while addressing safety and process issues promptly.
- Take ownership of departmental responsibilities, providing support through additional tasks as directed by leadership.
Benefits
- health insurance
- paid time off (PTO)
- retirement contributions
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
