Position Summary

The Site Head of Operation develops and implements a variety of strategies to maximize revenue while maintaining the highest level of quality, as well as working on improving the manufacturing operation to positively impact cost, quality and delivery time. The site Head of Operations provides oversight and guidance to subordinates as well as timely feedback to department leaders on operations-related issues, demonstrating a thorough knowledge of the company's services, client’s projects in addition to regulations and industry best practices.

Essential Functions and Responsibilities

• Directly accountable for the Manufacturing, Engineering and Facilities Operations, Environmental Health and Safety, Supply Chain, Validation, Manufacturing Science and Technology, Project Management and Human Resources for the site operations.


• Indirectly accountable for the Quality Assurance and Quality Control, from a business direction, informational respect and regulatory guidance.


• Develops and implements operational strategy for the site including (but not limited to) appropriate budget, investment, staffing and accurate reporting of billable and non-billable hours for all client projects.


• Assists the Technical Operation head and the Leadership team in the implementation of Quality and Business processes required to assure compliant cGMP (current Good Manufacturing Practices) manufacturing of client’s products in either a clinical or commercial setting on time and within budget.


• Monitors manufacturing capacities and communicates capabilities to the Business Leaders and Business Development for future opportunities.


• Assures staff has the proper training, skill set, and personal development opportunities to assure their ability to carry out assigned tasks in compliance with HCATS procedures and policy as well as local, federal and global regulations and industry standard.


• Assists in the development, execution and monthly tracking and reporting of assigned operational metrics.


• Works collaboratively with Quality Assurance, Quality Controls and Regulatory Affairs, Process Development, Global MSAT and Business Development, to ensure site and corporate goals are met.


• Develops and implements a continual Audit of the site for GMP, Safety, good housekeeping and compliance.


• Support EHS (Environmental, Health, and Safety) Manager to assure environmental and OSHA (Occupational Safety and Health Administration) compliance by developing appropriate safety, compliance, quality, and other relevant policies, procedures, goals and metrics.


• Accountable for ensuring the assigned plant consistently meets all cGMP and other regulatory requirements.


• Assures operations area is kept in a cGMP state of repair through coordination of preventive maintenance and cleaning activities with the Facilities department.


• Develops site recapitalization plan to ensure the site operations is stable and profitable.


• Responsible for ongoing development and improvement of the infrastructure necessary for the assigned plant to effectively and efficiently deliver against its vision, strategy, plans and objectives.  


• Builds a world-class team, develops talent and ensures a robust succession plan is in place, at all times for key positions in the plant. Develops a continuous improvement culture within the team.


• Drives and oversees regular and ad hoc risk assessment and mitigation planning and management.


• Leads and/or participates in various cross-functional teams or committees, e.g. Quality Task Force, S&OP (Sales and Operations Planning), Revenue & Resource.


• Develops and executes plans to meet or exceed manufacturing efficiency targets for clients.


• Interfaces with senior managers, peers and direct reports to maintain mutual understanding of product design needs, regulatory and production requirements.


• Works closely with internal and external colleagues on projects of existing and new products to ensure appropriate capacity, improve quality, adequate sourcing of critical components.


• Works to assure annual revenue targets are met by overseeing financial responsibilities which are within the positions control such as staffing, line item expense, capital requirements, capacity utilization.


• Support MSAT Process Development, Product Stewardship and Manufacturing Support groups to ensure smooth tech transfer of new products.


• Responsible for the initiation and deployment of site process improvement objectives and build the foundations to drive continuous, sustainable, flawless execution and performance through the application of operational excellence principles

Competencies

• Highly intelligent, perceptive individual who possesses excellent conceptual, analytical, and problem-solving ability.


• Ability to effectively interface with peer group in the company and work collaboratively to achieve company goals.


• Collaborates with other team members and demonstrates outstanding interpersonal skills.


• Ability to work autonomously in an entrepreneurial, fast paced environment.


• Strong business acumen


• Ability to think strategically and tactically (detail-oriented)


• Flexible and able to adapt to company growth and evolving responsibilities

Supervisory Responsibility

This position requires the management of personnel from Sr. Director level and below.

Qualifications

• Understand requirements pertaining to aseptic manufacture of cellular products.


• Bachelor’s degree in life sciences or an engineering discipline or an advanced degree (MS, PhD or MBA).


• Minimum of 15 years of relevant experience of which at least 5-10 years in a Senior Management role overseeing a manufacturing environment with applicable clinical or commercial experience.  Management of an aseptic biologics manufacturing facility is preferred. 


• Strong understanding of Validation (sterilization processes, equipment, clean rooms, processes, designs, etc.)


• Deep understanding of current Good Manufacturing Practices (cGMP) and (GCTP) Good Gene, Cellular and Tissue -Base Practices.  


• Working knowledge of financial operations and GAAP (Generally Accepted Accounting Principles) in a bottom-line oriented business.


• Knowledge of aseptic processing, supporting technologies.

Ability to work effectively with clients in a contract manufacturing environment.

• Familiarity with the product development process for biological products is helpful.

Background in lean, six sigma or other continuous improvement methodology desired.

• Ability to recruit, lead and develop a high-performance manufacturing organization.


• Capable to communicate in English 


• Strong written and oral communication skills

Working Environment

The job requires communication with the site leadership during and after working hours as well as working with challenging clients, contractors and advisory personnel.

Physical Requirements

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and /or move up to 15 pounds and occasionally lift and/or move up to 50 pounds