Production Lead Technician - Nights

Role Summary

Join our dynamic team as a Production Lead Technician, where you will train, support, operate equipment, and assign daily tasks to production technicians involved in the manufacturing of biological-based products. This role is pivotal in ensuring the smooth operation and continuous improvement of our production processes.

Responsibilities

• Assign and communicate daily tasks to Production Technicians through the Tier process.
• Complete manufacturing documentation per approved procedures; review for completeness and accuracy within established timelines.
• Operate processing equipment according to established SOPs, MPRs, and SPRs in compliance with cGMPs. Operations include solution preparation, cell culture, purification & formulation, and supporting activities.
• Serve as a qualified on-the-floor trainer.
• Be qualified in all processes within functional areas.
• Provide indirect supervision of Production Technicians.
• Contribute to annual performance evaluations of production technicians as applicable.
• Proactively investigate and resolve problems.
• Communicate clearly and concisely with Process Leads and Supervisors to resolve advanced issues on the floor.
• Complete SOP revisions.
• Lead level zero problem-solving initiatives.
• Manage deviations as needed.
• Support process improvements and new equipment introductions as needed.
• Lead inventory reconciliation processes in respective functional areas.
• Demonstrate expert equipment/process knowledge to diagnose issues and participate in first-line troubleshooting and root cause analysis.
• Suggest innovative solutions to non-routine events on the floor.
• Lead indirect processing activities in support of manufacturing operations.
• Lead continuous improvement initiatives.
• Build rapport with the team to effectively lead day-to-day floor operations.
• Adhere to AstraZeneca values and behaviors.
• Perform other duties as assigned or identified.

Qualifications

• Required: 3-4 years of experience with a Bachelor's degree, over 4 years with an Associate's degree, or over 5 years with a High School Diploma
• Required: Ability to work independently or collaboratively on assigned tasks
• Required: Effective communication, training, mentoring skills, and team leadership on day-to-day task completion
• Required: Ability to follow cGMP standards
• Required: Proficient computer skills
• Required: Substantial prior experience with aseptic/cGMP standards
• Required: Substantial prior experience in a bioprocessing work environment/systems/equipment operation

• Preferred: BS/BA degree preferred
• Preferred: Degree in a STEM field

Skills

• Effective communication, training, mentoring, and team leadership on day-to-day task completion
• Ability to work independently or collaboratively
• Proficient computer skills
• Experience with aseptic/cGMP standards
• Experience operating bioprocessing equipment and systems

Education

• BS/BA degree in a relevant field preferred