Location
Hamilton ON - Ontario
Country
Canada
Industry
Pharmaceutical
Date Posted
8/05/2020

Director of Manufacturing

Position Summary:

The manufacturing provides the following:

  • Organizational leadership in the areas of manufacturing & warehouse, related matters and ensures all decisions and practices are made in accordance with cGMP, Company Policies and H&S regulations.
  • Maintain a broad, flexible and strategic view of the manufacturing function and provide strategic/tactical direction to all related manufacturing and function.
  • Provide visionary leadership, innovation and acts as a change agent who will drive growth.

Responsibilities:

Leadership and Strategy

  • Participate in defining strategic goals and objectives for the manufacturing Department.
  • Contribute to the corporate vision by establishing the policies and infrastructure decisions that ensure linkage to the business strategy.
  • Lead cultural and organizational change, implement operational excellence and lean manufacturing for continuous improvement of competitiveness and financial performance.

Operations and Management

Commercial Manufacturing

  • Overseeing Manufacturing within a GMP regulated environment, ensuring that all processes are carried out in accordance with Health Canada, FDA, other regulatory bodies and Company regulations.
  • Responsible for cGMP compliance by defining, implementing and maintaining appropriate SOP’s and training.
  • Ensuring that GMP standards are applied such that the manufacturing facility is always prepared for regulatory and client inspections.
  • Responsible for Manufacturing related activities during audits by regulatory agencies.
  • Implement the appropriate team and departmental structure and establish the required processes and communications to enable the department to effectively deliver on all commitments.
  • Managing resources with supervisors (as applicable) to ensure that both output and schedules are met on a timely basis.
  • Facilitate rapid commercialization of new products utilizing traditional and continuous manufacturing technology in our industry-leading Quality by Design (QbD) environment.
  • Resolve complex commercial manufacturing issues
  • Conduct commercial continued process monitoring and process improvements. This includes the opportunity to apply statistical process control to recognize data trends and then implement improvements.
  • Developing strategic staffing plans and management policies (training, coaching, developing, interviewing).
  • Responsible for talent management (recruitment, development and retention).
  • Ensuring appropriate resources are available to meet the Company’s continued requirements for growth.
  • Preparing the annual budget for the Manufacturing Department and meeting the financial goals and objectives.
  • Accountable for product cost drivers, overall cost ownership, risk management and ongoing cost improvement for all products.
  • Contribute to facility and equipment design changes with a goal to optimize manufacturing processes.
  • Lead and facilitate the implementation of new systems, software, policies and procedures within the Manufacturing Department.
  • Responsible for ensuring consistent product delivery.
  • Manage external contractors and consultants to successfully achieve production, validation, calibration and maintenance objectives.
  • Establish quantitative metrics consistent with the Company’s business objectives.

Process Validation and New Product Launch

  • Develop and execute process validation strategies under quick timelines by working with cross functional teams including formulation development, analytical, quality, supply chain and regulatory to ensure creative and efficient implementation.
  • Formulate validation master plans, validation protocols, validation reports, continued process
  • monitoring plans and statistical sampling plans, among other important strategic documents.

Technology Transfer

  • Direct technology transfer to enable both continuous and traditional manufacturing at external
  • Provide technical input to supply chain, quality, and regulatory to formulate global regulatory strategy for qualification of new manufacturing sites.
  • The candidate must be an excellent collaborator and proven technical leader with experience in a cGMP pharmaceutical drug product manufacturing environment. The successful candidate will have a solid background in solid oral dosage form manufacturing.

Knowledge, Skills and Abilities

  • Excellent working knowledge of cGMPs within a pharmaceutical manufacturing facility.
  • Demonstrated ability to lead people and get results through others.
  • Strong technical expertise with a solution-oriented approach.
  • Strong quality mindset and willing to take the ownership in the face of challenges.
  • Proven track record of identifying and improving critical key performance indexes.
  • Experience establishing and implementing business strategies with a longer-term focus.
  • Proven leadership skills managing matrix teams, influencing outcomes and key project decisions.
  • Demonstrated strategic problem-solving ability.
  • Excellent knowledge of validation principles.
  • Ability to write, comprehend, edit and analyze complex documents.
  • Excellent organizational skills.
  • Ability to work with and collaborate with leaders of other departments such as but not limited to, IT, Security, Quality and Finance
  • Ability to work with and collaborate with external consultants and vendors

Experience/Education

  • A degree in Lifesciences or Engineering discipline
  • A minimum of 10-15 years of relevant experience within a highly regulated manufacturing facility specializing in solid dose manufacture with leadership of headcount greater than 15. A minimum of 10 years of leadership on a manufacturing floor.
  • Strong communication skills, both written and verbal.
  • Experience driving both continuous improvement and quality improvement initiatives.
  • Knowledge of secondary packaging systems and processes.
  • Experience leading within cross functional environments, driving decisions regarding overall manufacturing and supply chain priorities.



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