Vice President, Operations

Location
Sarasota, FL, United States
Posted
Feb 23, 2021
Ref
13914017
Required Education
Bachelors Degree
Position Type
Full time
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our rapidly expanding team. This role is an exciting opportunity to play a critical role within our organization that is accelerating the biotech industry's capabilities through the development of high-quality solutions to support the development and commercialization of advanced therapies. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer highly competitive benefits and perks to our highly valued associates.

The ideal candidate will oversee all day-to-day operations at two sites, including project and timeline management, budget, personnel, P&L and facility management.

General Responsibilities:
  • Directs the day-to-day operations of the facilities and all associated activities through both hands-on activities and supervision of staff to ensure a safe, compliant, and efficient organization.
  • Lead teams responsible for Manufacturing, Process Development, Quality Control, Facilities & Engineering, Calibration/Validation, Environmental/Safety and Supply Chain.
  • Core responsibilities will also include establish site strategies that effectively deliver consistent high-quality product to our pharma partners and ultimately their patients.
  • Set goals and objectives for sites and ensure that those are aligned with overall business strategy.
  • Lead a multi-site team to ensure that operations are executed consistently, safely, compliantly, effectively and efficiently to meet product demand and financial targets.
  • Develop manufacturing strategies, executing site operations, ensuring cGMP compliance, establishing new capabilities, processes and technologies, forming teams and developing people while creating an inclusive culture of safety, quality and operational excellence.
  • Collaborate closely with Quality & Regulatory Affairs, to maintain a high level of cGMP compliance and safety.
  • Closely collaborate with Process Development, and other related areas to execute technology transfers.
  • Oversee all Manufacturing operations, including production, and applicable support staff to meet production goals in alignment with the objectives of the organization.
  • Use sound project and financial management including preparation of and adherence to budgets and standards for cost measurement.
  • Develop and implement policies and procedures that ensure production activities are compliant with all governing regulatory, environmental, and safety directives.
  • Interfaces with clients throughout the program life cycles as needed.
  • Identify IT solutions needed to improve efficiencies in processes and personnel.
  • Is accountable for establishing and maintaining the cell therapy assets such as cell banks and key assets for the preservation of IP from the company and potential customers.
  • Incorporate Operational Excellence principals to ensure safety, quality, delivery, and cost effectiveness in operations, and sets a culture of continuous improvement and drive product/process improvements to improve reliability, quality, productivity and efficiency.
  • Ability to address vendors and aligned them with the internal needs Find novel solutions for existing and future customer needs
  • Problem-solving excellence in the biomanufacturing environment
  • Able to interact internally with quality assurance and regulatory stakeholders in the positioning of the company products and company strategy needs.
  • Understanding of process design and identify training needs for the team.
  • Closely interact with Commercial through the Sales & Operations Planning process to assure full and on time delivery of orders.
  • Develop and implement a continuous improvement program to drive out cost and increase efficiencies.

Requirements
  • BS or MS in Engineering, Business or a Life Sciences discipline or significant relevant experience
  • 15 or more years of experience in a biotech or biopharmaceutical operations leadership role, with broad responsibilities encompassing manufacturing, operation, engineering, and other related and other functions.
  • Proven ability in manufacturing to improve and refine a scalable production process.
  • Substantial experience in the direction and supervision of staff in a GMP environment.
  • Knowledgeable on Regulations regarding manufacturing biologics in the US, EU and Japan is a strong preference.
  • Experience in budget design and management.
  • Has ownership within the boundaries of the asset and willing to take on additional responsibilities as the organization is established.
  • Excellent verbal and written communications skills.
  • Problem solving proficiency.
  • Technically proficient in the manufacture of biologics, recombinant and native.
  • Bilingual English/Spanish preferred.