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Director/Senior Director, Manufacturing At 3DBio Therapeutics

Location: New York, New York

Job Description

The Director/Sr Director, Manufacturing will lead those functions with primary responsibility for ensuring the reliable, internal GMP supply of collagen to support external manufacturing. This will include leading internal staff responsible for product manufacture and coordinating external manufacturing with contract manufacturing organizations(s) and biopsy & product shipments from / to clinical sites. This individual will also be responsible for supply chain planning (demand planning, supply planning and materials planning), logistics and distribution (including warehouse / inventory control) in support of internal manufacturing.

This senior leadership role will provide strategic, leadership and direction to the Manufacturing and Supply Chain Management organization in alignment with 3D Bio's operational and long-term objectives. The Director/Sr Director will work closely with key stakeholders including Development, Quality, and corporate leadership to define and build the capabilities required to effectively manage 3D Bio's complex supply chain and support eventual launch and commercialization efforts.

Responsibilities to include:

  • Oversee staff and CMO's involved in product and intermediate manufacturing
  • Oversee staff, suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis.
  • Serve as the driver for development of internal manufacturing facility and infrastructure. Work with architecture and engineering teams to ensure that the facility is designed and constructed appropriately and delivered on time.
  • Oversee development of systems for equipment calibration, certification and qualification and ensure compliance with systems.
  • Direct communications with internal customers (QA, QC, Clinical…) and external manufacturers regarding supply, demand and scheduling issues.
  • Develop systems to support the internal manufacture of intermediates and the logistical coordination of regenerative medicine products with CMOs and clinical sites.
  • Work closely with other functions to drive overall supply chain efficiency and product delivery in a cost-efficient manner.
  • Drives development of relevant manufacturing metrics, data collection and reporting.
  • Support the development of regulatory CMC documentation and partner due diligence.
  • Work with the Quality organizations as necessary to ensure that any excursions, deviations, CAPAs… are initiated, addressed and closed within target timeframes.
  • Build and nurture employee engagement by creating environment within which individuals and teams can grow and excel. Serve as coach/mentor.
  • Prepares annual and multi-year financial budgets and forecasts. Manage headcount and expenses to meet approved spending plans while delivering on commitments.
  • Stay current with current industry standards, new trends and all applicable regulations.
  • Develop and maintain external relationships with subcontractors, and service providers.

Job Requirements

  • A minimum of 15 years in biopharmaceutical manufacturing management with a minimum of 10 years in leadership roles.
  • Degree in biology, biochemistry or similar related field required.
  • Advanced degree in supply chain management, operations management or similar relevant discipline preferred.
  • Proven experience in building manufacturing departments, processes and systems to support biopharmaceutical development (and commercialization preferred).
  • Experience leading contract manufacturing required. Experience with Cell Based Therapies, or Advanced Technology Medicinal Products preferred.
  • Must have strong knowledge of biologics manufacturing, materials management, and facilities management. Experience in cold chain management strongly preferred.

Personal Characteristics

  • Results oriented: Establishes clear expectations and priorities, sets objectives and effectively applies resources. Sets clear goals and consistently delivers. Flexible and creative problem-solving skills.
  • Strategic Thinker: Can see the big picture, able to constantly think ahead about ways to do things better. Thinks logically, develops and evaluates options, identifies pros and cons. Able to challenge current processes, practices and strategy and uncover alternative approaches, solutions or methods.
  • Team Leader: Proven track record of developing and managing a high performance team focused on accountability and meeting and exceeding expectations. Able to lead cross-functional and cross-cultural teams within a matrix organization and to manage multiple organizational interfaces and stakeholders; and to influence and to be accountable for team output. Also, willingness to serve as a player – coach and deliver results in a small, fast paced organization.
  • Communicator: Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill-sets to create, influence and negotiate win-win solutions.
  • Strong interpersonal skills: Has the ability to motivate others, influence without authority, and negotiate conflict situations. Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.

Self-directed: Individual who is able to work effectively with limited direction in a complex, fast-paced environment.