Manager, Drug Substance Operations

Role Summary

Manager, Drug Substance Operations. This role supports drug substance manufacturing in regulated, clean room environments complying with current Good Manufacturing Practices in the form of project management and shop floor leadership. The position is part of a capital project start-up in Durham, North Carolina, overseeing end-to-end processing of drug substances and drug products within a new facility.

Responsibilities

• First-line operations supervisor with a team of individual contributor production direct reports
• Supports project team as operations leader through start-up, qualification through licensure, and ramp-up of the facility
• Leads and provides input into continuous improvement opportunities
• Ensure that Shift(s) objectives are achieved while reliably supplying a quality product at a competitive cost
• Tactical and strategic Shift(s) management, including collaboration with indirect staff
• Promote the behaviors and principles that drive continuous improvement
• Typically, coordinates and supervises the daily activities of individual contributors
• Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors
• Decisions are guided by policies, procedures and business plan
• Interprets client and/or customer needs and assesses requirements
• Applies supervisory skills to improve efficiency and accomplish operational objectives within own unit
• Identifies and resolves standard day-to-day technical and operational problems within own unit
• Sets priorities for unit to meet daily deadlines; develops plans to meet short-term objectives
• Works within budgetary/financial objectives set by Director
• Reviews and approves compliance documents as needed; establishes a Right First Time culture by reducing waste and driving continuous improvement
• Supply/Support Tier - Exercise judgment to ensure a quality product is reliably produced while managing cost
• Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time)
• Develop strategic initiatives related to the manufacturing process, equipment, and human resources in support of long-range operating plans
• Report Shift(s) monthly metrics and action plans to address gaps to the Associate Director and/or Director
• Identify, prioritize, and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability, and eliminate waste
• Financial stewardship – meet Shift(s) operating budget and reduce cost; ensure team members understand business finances
• People management – coach on development, provide feedback and performance evaluations; support Talent Management
• Direct, coordinate, provide guidance to group leaders to assure optimum quality and quantity of finished products
• Keep team informed on current policies and plant communications; enforce safety rules and take corrective action as needed
• Lead in maintaining a high efficiency and productivity level with Safety First and Quality Always
• Identify root causes of manufacturing issues and implement corrective action to minimize downtime
• Actively develop team members to reach potential
• Support and lead/participate in the Hoshin process and strive to achieve the organization's vision

Qualifications

• High School Diploma and at least six (6) years in manufacturing, technical, support, or military role, or
• Bachelor’s degree in a technical field and at least four (4) years in manufacturing, technical, support, or military role, or
• Bachelor's degree and two (2) years of experience in a direct GMP, biotechnology, and manufacturing setting

Required Experience And Skills

• Ability to develop and lead others
• Ability to be flexible and understand the risk
• Continuous improvement
• Conflict resolution
• Adaptive leadership style; high-performance coaching; servant leadership
• Successfully maintain aseptic gowning qualifications
• TB Blood and Chest X-Ray clearance prior to start date

Preferred Experience And Skills

• Minimum two years in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.)
• Lean/Six Sigma knowledge
• Experience interacting with site, divisional or regulatory audits

Education

• High School Diploma AND at least six (6) years in a manufacturing, technical, support, or Military role; OR
• Bachelor’s degree in a technical field AND at least four (4) years in a manufacturing, technical, support, or Military role; OR
• Bachelor's degree and two (2) years of experience in a direct GMP, biotechnology, and manufacturing setting

Additional Requirements

• Shift: 2nd Shift - 2pm - 10:30pm with overtime as needed
• Travel: 10%
• Fitness to maintain aseptic gowning and safety compliance; TB/X-ray clearance prior to start