NAMSA is a growing, global company. We are looking for an experienced Associate who is highly competent in chemistry/analytical, extractable/leachables as well as experienced in leadership, management, has the ability to maintain a healthy P&L and has experience managing multiple sites both in the US and EMEA.
Analytical Services is one of our fastest growing areas and we expect to triple revenue over the next 3-5 years!
Qualifications and Skills
- Bachelor’s degree in scientific discipline Masters or advance degree preferred.
- Minimum 10 years related experience including 5 years management Profit & loss experience required.
- Experience in the medical device development process
- Experience working in a regulated environment (i.e., FDA, JP, EU).
- Fluency in English and local language, if different, required.
- Understands scientific principles used in the medical device and pharmaceutical industries and can direct laboratory teams to develop and validate novel Thorough understanding of compliance requirements of the FDA, European notified Bodies, the Japanese Pharmacopoeia, British Pharmacopoeia, and European Pharmacopoeia.
- Publishing and speaking
- Understanding of medical device regulatory
Principal Duties and Responsibilities
- Plans, directs, and coordinates the technical, operational, and financial activities of all Analytical Services Laboratories in all locations globally.
- Ensures timely delivery of testing services, ensures laboratories operate in compliance with applicable quality and regulatory
- Interacts directly with clients, assuring scientific, quality and service needs are being met
- Establishes continuous productivity improvement programs, manages cost-of-goods sold (COGS), gross margins and profit-from-operations (PFO).
- Develops, motivates, and mentors Managers, Supervisors and
- Assures that the department adheres to, supports, and implements all corporate policies and Assure compliance with applicable requirements of ISO 13485 & 17025, FDA, DEA, OSHA and local health agencies.
- Directs and accomplishes financial objectives for the Analytical Services labs by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions; effective utilization of equipment, supplies, and
- Establishes department goals by gathering pertinent business, financial, service, and operations information; identifying and evaluating trends and options; choosing a course of action; defining objectives; evaluating
- Attends and represents NAMSA Analytical Services at technical conferences, trade shows, standards setting organizations and meetings with government agencies.
- Supports NAMSA’s MRO activities and may serve as functional leader or management representative to clients when appropriat
- Supports new methods or procedures that will broaden the capability of the company and favorably affect NAMSA’s reputation in the device
- Ensures collaboration with Marketing and Sales to contribute to the growth and industry recognition of Analytical