Senior Director of Operations

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Job description

Overview:
Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We're investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you're curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Senior Director of Operations at Cook MyoSite is responsible for translating global business priorities into operational directives to achieve financial and strategic goals.

Responsibilities:
• Participate with other executives in formulating current and long-range strategies, objectives, and global policies.
• Create scale out plan that gives Engineering functions the requirements for achieving plan including use of all current and future assets.
• Formulate and implement new strategies and policies and procedures and translate strategy into actionable goals for performance and growth.
• Implement organization-wide goal setting, performance management, and annual operating planning.
• Ensure business continuity across all operational functions.
• Direct operational excellence mindset and actions to improve system efficiencies and cost effectiveness.
• Work with key stakeholders to develop and manage budgets with focus on product costs, margins and overall profitability.
• Develop and control plans for capital, operating expenditures, manpower, wages and salaries.
• Coach staff on how to evolve from development to commercial operations.
• Prepare team for pre-approval inspections and quality compliance audits.
• Work with Quality leadership to establish key metrics to monitor overall plant performance for production and quality standards.
• Direct Environmental Health and Safety personnel to implement and maintain a safety environment in compliance with applicable Occupation Safety and Health Administration (OSHA) regulations.
• Incorporate facility organization and plant operational flow among personnel.
• Work with business and clinical function leadership to create strategy for maximizing production, minimizing risk, and responding to market changes effectively and efficiently.
• Actively look for opportunities to improve quality.
• Provide tools and training necessary to make processes flow smoothly and effectively.
• Provide performance management and career development to direct staff.
• Identify potential problems and create solutions before they occur.
• Optimize processes and ensure sufficient controls and measures for process consistency.
• Facilitate cross-functional communication to enable adaptability between teams and departments.

Qualifications:
• Undergraduate or master's degree in any Life Sciences, Engineering, or Business field is required

• Minimum of 15 years' experience in Biotechnology is preferred

• Minimum of 10 years' experience with exposure to cGMP environment in cell therapy/regenerative medicine field is preferred
• Experience in both development and commercial manufacturing environments is preferred
• Knowledge of FDA and foreign regulatory requirements as well as industry quality management tools, trends, practices, standards, and the quality system is preferred
• Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology, and laboratory operations in a manufacturing environment is preferred

• Ensures directorate/department is managing and meeting annual budget.

• Responsible for the planning and the timely submission of directorate/department budget requests and considerations to the Vice President(s) and finance department in accordance with the annual budgeting timeline.
• Responsible for short and longer-term company impacting decisions and output.
• Effectively delegates and follows up on completion of work.
• Regularly and consistently provides status reports on all active projects and initiatives to Vice President(s.)
• Develops, reviews, and enforces company policies.
• Ability to present highly complex information to a broad audience in a clear and comprehensive manner.

• Oversees direct reports: Creates and executes short and long-term staff development plans.
• Conducts performance reviews that hold direct reports accountable to essential job functions and departmental standards of position.
• Ensures that directorate status meetings are held on regular basis and conducts monthly one on one meetings with direct reports.
• Directly responsible for directorate staff resource planning.
• Responsible for departmental hiring decisions and participates in recruitment of staff.
• Makes decisions and ensures the successful completion of strategic initiatives that are aligned with quality, operational and business best practices.
• Develops and communicates the overall strategic vision for the organization

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook
• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

Physical Requirements:

• Laboratory Setting (Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.