Durham, NC 27709
Salary: $90,000.00 to $130,000.00 /year
Director of Consumable Manufacturing
Baebies Inc. (www.baebies.com) is a well-funded growth-stage company that develops and commercializes products for testing in the newborn screening and pediatric diagnostic markets. The company’s existing FDA-cleared SEEKER product is sought by US public health labs, where the majority of biochemical newborn screening occurs. The company has shipped over 8 million SEEKER tests to date. Baebies second diagnostic platform, FINDER, is 510(k) pending and is poised for explosive growth in the near term.
The Director of Consumable Manufacturing plans, organizes, directs, and controls the activities of the consumable manufacturing (digital microfluidics technology) portion of operations. The position will lead the expansion of consumable manufacturing operations and the required staff to support the company’s growth.
Reports to:VP Operations
DUTIES AND RESPONSIBILITIES:
- Is totally bought in to achieve the mission and to fulfill Baebies’ outrageous growth expectations.
- Executes consumable production to meet delivery, quality, regulatory, and cost requirements.
- Collaborates with product development teams to successfully transition new products to operations.
- Leads efforts to solve problems related to consumable products and to reduce the cost of consumable goods. Knows where every dime is spent and is always looking for product cost reduction opportunities to drive margin improvement.
- Leads efforts to proactively increase manufacturing capacity where needed. Develops and executes plans for new manufacturing equipment and process capability where needed.
- Recruits, selects, on-boards, trains and retains qualified personnel. Always working to make the team function and perform better.
- Ensures consumable operations compliance with quality system and other relevant regulations.
- Develops, modifies, improves and reports operational metrics for consumables as a part of an ongoing performance improvement program.
- Collaborates with other operations and non-operations departments in carrying out all responsibilities.
- Successfully builds relationships across functions at multiple levels within operations.
- Strong analytical and problem solving skills
- Ability to adapt in a fast growing and dynamic environment
- Strong problem solving, communication skills and project management skills required
- Proven manager and leader of manufacturing teams
- Excellent interpersonal skills and the proven ability to work well with all levels of management and staff
- Understanding of FDA quality system requirements
EDUCATION AND EXPERIENCE REQUIRED:
- Bachelor’ Degree or greater in a scientific field, MBA a plus
- 10+ years’ experience in consumable manufacturing environment, 3+ years in a senior manager or director level position
- Experience with FDA-regulated IVD manufacturer