Lead Manufacturing Associate
About The Position
As a Lead Manufacturing Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands. You will oversee floor operations to ensure safety, aseptic operations and compliance to ensure cGMPs are maintained. Ensure efficient use of material and equipment and assign personnel in the execution of daily operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices into manufacturing.
Requirements
- Normally requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing
- Proficient in aseptic technique
- Operational knowledge of Systems and general equipment
- Experience with systems such as SAP, LIMS and TrackWise
- Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department.
Nice To Haves
- Biotech Certificate and prior leadership experience is ideal.
Responsibilities
- Primary contact for troubleshooting and issue resolution or escalation
- Create and follow-up on work orders
- Communicate/ coordinate days scheduling and staffing plan
- Re-allocate staff during the day (breaks, lunch, training)
- Oversight and execution of all routine and critical operations and commissioning and changeover validation activities
- Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records)
- Responsible for floor inventory and communicating schedule changes
- Monitor materials and coordinate all materials deliveries
- Recommend/Implement process changes/improvements or safety/ergonomic improvements.
- Ensure work is carried out in a safe manner, notifying management of safety issues
- Tiered visual management and continuous improvement
- Support tech transfer activities
- Interview candidates
- Provide feedback on staff's performance
- Address minor personnel issues
- Escalate major personnel issue to the supervisor
- Ensure staff compliance with all relevant documentation and safety guidelines
- Initiate deviations or investigations of multiple complexities and work with different departments to identify root-cause
- Implement appropriate corrective actions
- Complete action items for GMP investigations and CAPA's
- Assist supervisor/engineer/facilities with investigations
- Revise and author GMP documentation
- Communicate any quality issues/concerns to Supervisor and QA
- Be a role model (Lead by Example)
- Be a resource/SME for staff
- Ensure the use of safe work practices and behaviors
- Conduct training and assess effectiveness
- Help identify training needs
- Assess staff skills and provide feedback to Supervisor.
- Develop training material
- Provide training
- Expected to act on behalf of the supervisor while on the floor
Benefits
- U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
