GMP Manufacturing Technical Lead
Employment Type: Full-Time
Aldevron is seeking aGMP Manufacturing Technical Lead to oversee multiple projects simultaneously within the GMP manufacturing areaswith a focus on first time right and patient first in full conformance with Quality and EHS requirements. This role is hands-on and will assist the manufacturing team and supervisors as directed, and fill in when supervisors are not available (eg. after hours, during PTO, and unplanned absences).
About the Role:
- Responsible for the oversight (from planning through execution) of multiple Biomanufacturing operations/ projects weekly, including a constant state of operational readiness and execution through efficient utilization of staff resources and production rooms
- Ensure manufacturing teams are on track and completing projects appropriately through application of technical and regulatory knowledge and experience
- Critically review technical details and proactively work with internal teams to resolve issues
- Ensure appropriate progress against deliverables and timelines; identify and solve technical issues and schedule problems by proposing appropriate risk response strategies when situations arise
- Collaboratively improve and/or troubleshoot manufacturing processes
- Instruct and train colleagues on manufacturing procedures
- Lead training events for trainee's on production processes when required. Assist with training program as needed
- Support completion and periodic updates on GMP Standard Operating Procedures and production records
- Provide technical expertise to the manufacturing team and Technical Writer staff
- Support Initiation and completion of Deviations, Non-conforming Material Reports and Corrective Action tasks
- Lead Corrective Action investigation work as well as supporting tasks required for the implementation of the corrective action plan
- Perform technical peer review of production records and procedures for accuracy and compliance
- At least 2 years of related manufacturing experience
- High school diploma required. A.S. or B.S. degree in life sciences preferred
- Excellent communication that can distill complex concepts with clarity of thought in a concise and factual manner
- Strong knowledge of computers, Microsoft Office, and Smartsheet
- Follow-through on methodology, understanding that bacteria are living organisms that do not adhere to a schedule
- Ability to apply scientific and technical knowledge to provide solutions for the advancement of the projects in alignment with specification deliverables
- Ability to use knowledge and interpersonal skills to influence and guide internal team to meet all project and organizational objectives
- Ability to be on call when required.
- Ability to work effectively as part of a team
- Ability to follow written procedures, and written and verbal directions
- Ability to keep records and maintain files
- Ability to adhere to health, safety and sanitation procedures
- Ability to self-report mistakes or concerns to reporting manager
Why Join Aldevron?
- You want meaningful work.We are in a landmark moment in the history of life science, and Aldevron is at the center of it.
- You want to plant your career in a growing company.We are growing fast.We have limitless opportunities for people who are ready to roll up their sleeves and jump in.
- You are excited to learn every day. At Aldevron, no day is the same. Our team comes to work ready to learn and overcome new challenges with teamwork and a passion to make lives better.
Your talents, ideas, and passion are essential to our success. Join us today!
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