This role provides leadership to the operations team, embeds systems and processes to manage people and resources to achieve business objectives. The successful candidate will be responsible for the oversight of operational functions including facility/equipment, supply chain, human resources management, health & safety, and materials to enable the company to meet internal and external customer demands in a cost effective and timely fashion. Accountable for the implementation and execution of day-to-day activities and for delivering on plans to support business strategy. Develop the operations team to improve employee engagement and create a culture of accountability and continuous improvement.
The ideal candidate will be a natural leader familiar with the pace of an early-stage company and have excellent time management leadership and skills. This includes managing and contributing to multiple, concurrent projects. This candidate will excel in a fast-paced work environment characterized by client-driven deadlines and evolving priorities.
- Strategies, systems and processes for product & process development and manufacturing for areas within functional oversight.
- Collaborate closely with the Quality Manager, Project Manager, and cross-functional project teams to establish plans and drive projects to successful completion in a timely manner.
- Ensure the schedules of the people, facility, equipment, materials, and documents are established and maintained to support operational activities.
- Participate in the design control process and lead new product and technology transfer activities aligned with business objectives.
- Build business relationships with external stakeholders, including CMOs, provide technical lead support and monitor service levels so they are maintained and improved.
- Generate, review, and approve documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports.
- Establish the generation, maintenance, and coordination of the Master Validation Plan and support execution of validation activities.
- Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective products to patients.
- Lead and motivate the operations team, ensuring the behavioural expectations of team members are established.
- Conduct or participate in investigations related to Nonconformance and/or Corrective and Preventive Actions related to Operations.
- Work closely with Quality to maintain compliance with regulatory requirements, company policies and procedures.
- Support Regulatory Submissions.
Key Knowledge, Skills and Qualifications
- Requires a Bachelor’s Degree in Engineering or other science.
- At least five (5) years of relevant experience with a minimum of two (2) years management experience.
- Direct leadership and hands on experience in Medical Device manufacturing or another highly regulated industry (Pharma, Chemicals, Aerospace, Food) highly preferred.
- Familiarity with Manufacturing Engineering (Bills of Material, Batch Sizes, Costing, Lot Release/History, Monitoring, CAPAs, etc.).
- Strong verbal and written communication skills, including technical writing and the ability to communicate with internal and external customers.
- Computer proficiency (MS Office 365 - Word, Excel, PowerPoint, Access, and Teams).
- Ability to work both independently and collaboratively
- Be self-driven & proactive.
- Time management and task management.
- Conflict resolution.
- Decision making.
Additional Job Requirements
- Ability to work overtime and weekends on occasion.
- Some travel may be required.
Please submit your application through LinkedIn here. We thank all applicants for their interest, however only those selected for an interview will be contacted.
You can learn more about IR-Scientific on their website here.