Manager, Drug Substance Operations 2nd Shift

Job Description

This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substances, drug products, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.

As the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the Operations team in this new and exciting facility will have the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production.

The ideal candidate for this role will be an energetic leader with strong interpersonal, leadership, collaboration skills, and has demonstrated the ability to meet immediate business objectives even through adversity. This role will support drug product in regulated, clean room environments complying with current Good Manufacturing Practices in the form of project management and ultimately shop floor leadership.

Key Responsibilities for a Project Flash Operations Manager

Accountability | Project Support

· First-line operations supervisor with a team of individual contributor production direct reports

· Supports project team as operations leader through start-up, commissioning, qualification through licensure, and ramp-up of the facility.

· Leads and provides input into continuous improvement opportunities.

Accountability | Operational Leadership

· Ensure that Shift(s) objectives are achieved while reliably supplying a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal employment opportunity, finances, labor, employee, environment, and safety, not in that order.

· Tactical and strategic Shift(s) management, including collaboration with indirect staff.

· Promote the behaviors and principles that drive continuous improvement.

Additional

· 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 | Receives guidance and oversight from Operations Associate Director and Director

· 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.

· Makes decisions guided by policies and standard operating procedures that impact the efficiency and effectiveness of own unit.

· Compliance - Creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business | Establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement | Review and approve compliance documents, as per procedures or need.

· Supply/Support Tier - Exercise judgment and decision making 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, etc.)

· Continuous Improvement - Accountable for developing a Company Production System (CPS) and continuous improvement culture while achieving CPS Targets and business results for the Shift(s) | 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 any 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 – Accountable for meeting the Shift(s) operating budget and continuously reducing cost | Ensure members of the Shift(s) have business acumen and understand how they may impact business finances.

· People Management – Creating and sustaining a highly engaged workforce through the utilization of Company Leadership Behaviors and Inclusion | Provide coaching on professional development and career paths | Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation | Provide f