• Job Description

  Req#: 16702

  Overview

  Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, 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 Executive Team is a unified, collaborative leadership team tasked with developing, communicating, championing and leading annual strategies, objectives, and plans to achieve the company's long-term objectives that support the company's overall strategy as established with the VPs, to achieve the company's Mission and Vision. They ensure the successful completion of strategic initiatives and that the work within their directorates adheres to budget guidelines, quality, operations, and business best practices. They are accountable for the alignment of their strategic assignments with the overall strategy of the organization as well as the impact that their results have on other directorates and the overall organization.

  Global Commercial Lead, Custom Cell Solutions will lead the development and execution of commercial strategies for the Custom Cell Solutions division that maximizes capabilities and assets, product launch and contract manufacturing activities, and sustained market growth.

  Responsibilities

  • Build and execute strategic plans to achieve division revenue and profitability objectives.• Assess new business opportunities for alignment to company goals and capabilities.• Set strategic goals for business development and sales.• Work with leadership in Manufacturing Operations and Shared Services to execute won contracts on time and on budget and to ensure proper planning occurs and product inventory meets customer demands.• Work with leadership in Quality to ensure compliance between GMP and non-GMP operations, as applicable.• Work with leadership in Product Development and Process Engineering to ensure healthy product and service pipeline.• Work with leadership in Brand and Marketing to grow customer base.• Sign contractual agreements to carry out financial objectives and ensure compliance and execution of the commitments.• Ensure compliance for handling of human biological samples and vendor relationships with Organ Procurement Organizations and other sources of human tissue.• Direct market and business intelligence efforts to understand competitive landscape and business opportunities.• Proactively perform comprehensive assessments of competition and identification of opportunities to guide/refine the global strategy amidst rapidly changing market dynamics• Contribute to MYO Therapeutic Portfolio division objectives as appropriate.• 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.• Is an effective communicator with internal and external stakeholders. Conveys clear expectations, actively listens to input and responds to feedback appropriately and in a timely manner.• Is action orientated and follows up on feedback to ensure positive outcomes.• Accountable for successful organizational outcomes and holds teams accountable for all stated responsibilities.• Is a critical thinker with proven problem-solving and decision-making abilities. • Ensures company maintains focus on our customers. • Exhibits well-developed prioritization, planning, organization and time management skills.• Acts as management with executive responsibility.• 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

  Qualifications

  Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in OutlookBasic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturingMaster’s degree or higher in Biology, Engineering, or other Life SciencesMinimum of 15 years' experience in biotech/pharmaceuticals; experience running contract manufacturing operations

  Minimum of 10 years in the Cell and Gene Therapy field

  Hybrid

  Physical Requirements

  • 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.

  Employee that interacts with Healthcare Professional: In addition to below, Compliance with Cook Policy & Guidance On Interaction with Healthcare Professionals.Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

  At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.

  This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.

• About the company

  Cook Group Incorporated is an American privately held company based in Bloomington, Indiana, and primarily involved in manufacturing of medical devices.

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