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.
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
- 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.
- 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
- 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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