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In this vital role you will support the Downstream Manufacturing Operations according to Standard Operating Procedures (SOPs). Will perform and supervise critical processes, execute routine protocols, and regularly draft and revise documents such as Manufacturing Procedures and SOPs. Perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams. May identify, recommend, and implement improvements related to routine functions in a Non-Standard Shift environment. Multiple Positions Available.
Job Responsibility:
Lead the execution of complex manufacturing processes and systems, developing non-routine procedures and documentation as needed to support production efficiency
Serve as a subject matter expert and trainer for Operators and Associates, sharing knowledge and best practices to build team capability
Accurately and promptly enter data into systems such as LIMS, LMES, and SAP, ensuring compliance with Good Documentation Practices and cGMP standards
Revise SOPs and batch records to improve clarity, efficiency, and compliance, while maintaining a high standard for detail and accuracy
Collaborate with cross-functional teams to support process improvements, share insights, and align on production goals and timelines
Respond quickly to production issues, conduct root cause analyses, and propose corrective actions to minimize disruptions and prevent recurrence
Monitor safety conditions on the floor and model adherence to safety protocols, promoting a culture of accountability and compliance
Analyze process data and critical parameters to assess quality impact and support decision-making during deviations or CAPAs
Inspire team performance by connecting daily work to broader organizational goals, setting high standards, and encouraging continuous improvement
Actively seek and implement feedback from peers and team members to enhance line performance and develop a culture of learning and innovation
Requirements:
Master's Degree
Or Bachelor’s Degree + 6 months Manufacturing work experience
Or Associate’s degree + 2 years Manufacturing work experience
Or High school/GED + 4 years Manufacturing work experience
Experience with purification, buffer and component preparation process
Availability to the Third Shift including rotative weekdays and weekends
Proficient experience of performing basic operations and understanding equipment per procedures
Knowledge of basic computer systems including Microsoft Office, SAP, MES, LIMS
Educational background in Life Sciences, Biotechnology or Engineering
Experience working in a GMP regulated environment within the biotechnology, pharmaceutical or medical device industry
Excellent communication, organization, attention to detail and technical writing skills
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown