Sr. Manager, Operations, Advanced Drug Delivery (ADD)

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Sr. Operations Manager is responsible for the safety, quality, and operational excellence for Advanced Drug Delivery value stream. In this role they provide leadership to the Operation Team and have dotted line relationships with the support departments, Maintenance, Warehouse, Quality, and other Value Stream members. This role is critical in driving continuous improvement, focused on their assign value stream, in areas of safety, quality, production uptime, major and minor change overs, scrap, labor utilization, and profitability.

Essential Duties and Responsibilities:

• Direct the daily activities of Operations, in compliance with company policies and procedures, along with all federal, state and local regulations, including OSHA, FDA, cGMP standards and employment law
• Demonstrate substantial knowledge of the pharmaceutical industry, including cGMP, regulatory compliance, best practices, emerging trends and be the subject matter expert and escalation point for all complex, high impacting operating decisions.
• Responsible for the Operations Safety culture and results, own and drive safety improvements, and collaborate and support EH&S on safety programs and initiatives on their shift and in their value stream. Ensure all safety incidents on their shift are investigated, root cause determined, and corrective actions identified and implemented to mitigate future risk.
• Responsible for the Quality culture and results and value stream, ensuring each product is made to specification. Own and drive improvements in the areas of Right the First Time, Deviations, and Investigations. Develop corrective and preventative actions associated with Critical & Major deviations to ensure alignment across all functional teams. Ensure successful regulatory and customer audits the assigned responsible areas.
• Provide leadership to the Operations Team, , through positive coaching, training, and guidance; drive actions through direct reports to achieve safety, quality, and operational metrics; hold team accountable for performance against targets in all key areas; build and retain a high functioning team to create a positive employee culture that is focused on safety, quality, and delivering products on time.
• Maintain constant focus on customer satisfaction and direct all activities to manufacture and deliver a quality product on time, to specification, and at the lowest reasonable cost to meet customer needs.
• Coordinate activities of departments such as Production, Warehouse, Maintenance, Engineering, Validations, and QC to affect operational efficiency on the shift assigned.
• Support Business Units through the preparation and hosting of Customer visits/audits; responding promptly to requests for service and assistance.
• Foster and instill a continuous improvement mindset and value stream. Identify and drive continuous improvement projects to improve safety, quality, and operational performance to achieve budgeted cost savings. Deliver year over year improvement in key operational areas including schedule adherence, on-time delivery, uptime, lot changes, and scrap. Utilizes Lean Six Sigma knowledge and tools, including 5S, Value Stream Mapping, Kaizen events, standard work, and health checks, to ensure sustainability.
• Lead improvement teams as required due to operational and/or quality issues. Utilizing data, identify the gaps/issues and develop an action plan to provide confidence and reassurance in PCI's ability to deliver a quality product on time within the assigned value stream.
• Hire, develop, and train Operations Supervisors and other staff reporting directly to this Operations Role. Oversee and participate in the interview/selection process of hiring.
• Responsible for maintaining proper staffing levels in order to support production needs.
• Must be able to apply the appropriate work life balance to ensure organizational goals are met.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor.
• Demonstrate substantial knowledge of operational and quality Advanced Drug Delivery processes including 100% reconciliation, time out of refrigeration management, robust material flow movement, and high-speed, automated equipment systems
• Develop strategic training plans for critical operations talent to meet complex quality and operational ADD processes. Assess key training roles and resources to support training execution.
• Develop, implement, and maintain alternative shift schedules and labor models to meet ADD business demand and maximize production efficiency
• Partner with Process Engineering team to develop and sustain performance management infrastructure to meet key ADD operational metrics
• Optimize and adapt technical labor models to support highly complex. automated assembly and packaging equipment processes.

Required:

• Bachelor's Degree in a related field and/or 7-10 years related experience and/or training.
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• Supervisory Responsibilities

Preferred:

• Ability to display excellent time management skills.
• Ability to identify and resolve problems in a timely manner.
• Ability to effectively present information to various people as the job requires.

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.