Minneapolis, MN area. This company is looking for someone with experience in any type of drug/device combinations, including OINDPs; it is dedicated to the development and commercialization of the safest, most efficacious drug coated balloon for the treatment of coronary and peripheral vascular disease. Given the stage of development and the need to establish and ramp up commercial efforts, the company seeks to attract a world class VP Manufacturing Operations (VPMO) to scale all operations, supply chain and related functions.
Education and Experience
• 10+ years of demonstrated leadership experience in a world class manufacturing/operations environment in an FDA regulated industry (preferably with experience in any type of drug/device combination).
• Demonstrated strong working knowledge of supply chain management at both the development stage for clinical supplies as well as at the commercial stage is considered essential for the position.
• Understanding and experience with the CMC content of regulatory submissions highly desirable.
• Preferred qualifications include understandings of: formulation/drug product process development and scale-up; packaging, cGMPs, and ICH guidelines.
• Demonstrated Lean Manufacturing and/or Six Sigma experience is desirable.
• Four year degree in Biomedical Engineering, Mechanical Engineering or other related engineering, technical or Life Science discipline.
Position summary
Reporting to the COO, the VPMO will play a critical role in developing and leading the Company’s operations function to ensure the development and ongoing evolution of its core competencies into a world-class manufacturing organization. This position will be responsible for establishing the Company’s initial manufacturing facility (clean rooms, warehousing, validated process and procedures, etc.) in support of commercial production of the enterprise. This includes managing the day-to-day activities of a combination (pharmaceutical/ medical device) product plant, overseeing the scale-up to manufacturing activities and compliance with all appropriate regulations (cGMP, ISO13485, etc). The VPMO is expected to ensure that the Company consistently meets or exceeds quality standards in products, ensure customer fulfillment is not compromised, and ensure that the organization is trained to the standards of operational excellence and technical competency utilizing best-in-class processes and practices.
Responsibilities
• Lead the implementation of the Company’s initial manufacturing operations for CE approved product and planned US commercialization following PMA approval.
• Ensure compliance with ISO and GMP standards of all manufacturing operations, policies and procedures.
• Coordinate with R&D all activities associated with transfer to manufacturing and process validation. This includes documentation, supply-chain management and regulatory body facility approval.
• Manage operating support activities, including: master scheduling, production & inventory control, purchasing, and shipping and receiving.
• Maintain quality of products according to established standards and procedures through all phases of production processes. Monitors the quality, efficiency and effectiveness for manufacturing performance.
• Provide input and ensures compliance with the Company’s design control system in compliance with all acknowledged regulations and guidance’s (i.e. CFR Part 820, ISO 14385, MDD, etc.).
• Accountable for the safety, environmental compliance, quality, cost, delivery and responsiveness performance and continuous improvement performance of the operations.
• Promote continuous improvement initiatives including Lean Manufacturing and 6 Sigma
• Maintain optimal inventory and productivity of raw materials and finished goods.
• Leads direction and decisions as required supporting corporate growth and strategies by coordinating with the functional leaders of the Company, recommending improvements, and implementing agreed upon initiatives.
• Recommends and implements plant equipment acquisitions and layout. Works with equipment suppliers on equipment specifications, quoting of specified equipment and delivery schedules.
• Ensure output, timeliness, quality and cost to standards consistent with customer requirements and Company strategy.
• Oversees the development of the organization and operation in a growing business.
• Maintain positive Human Relations within a growing business.
• Any other duties as assigned.
Compensation
The company is prepared to offer an attractive base salary and incentive compensation plan along with a primary vehicle of wealth accumulation through equity participation.
The company is an equal opportunity employer who employs without regard to race, color, religion, ethnicity, national origin, age, sex, or marital, veteran, disability, or any other status protected by current law.
Contact Daniel M. O’Hara, O’Hara Associates, Inc, +1 847 405 0601 #226, dan@oharainc.com
