Manufacturing Specialist

Payrate: $34.00 - $36.00/hr.
 
Summary:
Join our team at Drug Product Manufacturing Facility, where we strive to serve every patient, every time. In this critical role, you will be responsible for the introduction of new products into the manufacturing plant. You will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20. This role requires a high degree of interaction and collaboration across key functions, including Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering.
 
Responsibilities

• Develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
• Resolve issues in a timely manner and elevate cross-functional customer concerns to various levels of management as appropriate.
• Own Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures.
• Proactively lead cross-functional team meetings to ensure NPI project(s) and other relevant business cases execute per schedule.
• Communicate succinctly verbally, in writing, and through presentations to peers and senior leadership team.
• Engage with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions.
• Document Lessons Learned and present to management when appropriate.
• Review protocols for manufacturing activities and partner with Quality Assurance to ensure GMP standards are maintained.
• Identify and implement improvement opportunities within the organization.
• Perform Gemba walks in the manufacturing plant to identify process improvement opportunities.
• Report on team and plant metrics to ensure visibility to team operations and deliverables.
• Represent the team at plant-wide and network-wide forums as needed.

 
Qualifications

• Project Management experience
• Direct and/or indirect people management / leadership experience
• Understanding of Drug Product Formulation and Vial/Syringe Filling operations
• Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
• Strong organization and technical writing skills
• Independent, self-motivated, able to multi-task in a fast-paced environment
• Team-player
• Demonstrated flexibility and ability to manage change
• Direct experience with regulated environments (e.g., cGMP etc.)

 
Skills

• Organized, cross-functional relationship builder
• Able to articulate and communicate problem statements clearly, with a quality-first mindset
• Independent problem solver

 
Pay Transparency: The typical base pay for this role across the U.S. is: $34.00 - $36.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
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