Title: VP, Lab Operations US
Reporting to: Global CEO
Functional Reporting: Global Head of Operations in Europe
Location: California Preferred but would consider remote
Compensation: Commensurate with experience plus hyper-competitive benefits
- Our client offers unique technologies and solutions that provide clinical researchers and oncologists with critical tools to analyze, detect and stratify disease at a single-cell level. Their mission and passion is to advance healthcare and personalized medicine by creating technologies and products that help uncover the biological complexities of health and disease at the level of individualized cells.
- Their strategic direction is to be at the forefront of new diagnostic and therapeutic approaches to human health by enabling detection and analysis of important but rare cells associated with disease, and to provide researchers and oncologists with access to unparalleled precision in molecular characterisation.
- The VP, Lab Operations US has responsibility for the management and leadership of US Production, Quality Control (“QC”), Facilities and Health and Safety functions. In addition, the incumbent will also be accountable for the improvement of core processes that result in improved product availability, quality, and improved cost, which may also involve the additional coordination of R&D and Supply Chain activities at site level.
- The role will ensure that performance metrics are met by focusing on respect of demand planning, reduction of quality events, and improvement of the processes. In this role the VP, Industrial Operations US will directly report into the Global CEO.
- In addition, the incumbent will have a functional reporting line to the Global Head of Operations and is responsible to ensure the plant works according to the Group quality standards. The VP, Lab Operations US represents the site together with Corporate QA and the CEO towards national and other authorities and corporate clients. The incumbent is also responsible for Health, Safety and Environment (HSE) of the site according to US Laws and Regulations.
- A key deliverable will be the establishing and fostering of high performance cross functional teams. Coaching and training of area key staff with respect to GMP. Develop and implement an effective manufacturing planning & execution system to maximize manufacturing capacity utilization.
- Proposes a suitable organizational structure and hires of appropriate personnel (employees and/or consultants) in order to execute manufacturing activities and development projects in a timely, efficient and compliant manner
- Owns and actively manages the allocation of personnel ensuring that personnel and equipment resources are utilized as efficient as possible,
- Ensures that all cross-functional organizations cooperate seamlessly and in very close alignment.
- Makes sure that GMP requirements are met and that the Quality Management System (QMS) fulfills international standards
- Serves as subject matter expert to support Operations and Quality when complex issues need to be solved and business critical decisions need to be made. Scale up and implement state of the art unit operations.
- Continuously evaluates and optimizes the organization (personnel and work flows) to support current project needs and goals (i.e. Tech Transfer-, Investigation- and Validation teams)
- Ensures that health, safety and environmental (HSE) guidelines are implemented and followed. Continuously improves safety and environmental standards on site in close collaboration with Corporate and local HSE functions.
- Establish goals for performance and report progress regularly to upper management
- Manage and lead component procurement efforts to ensure stable supply chain and inventory levels
- Routinely analyze manufacturing and production operations for efficiency
- Fulfill business goals and report to executive management any manufacturing challenges and business needs
- Monitor and trend data for continuous process improvement
- Lead new product design transfer and introduction to manufacturing ensuring smooth transition of new product introduction and product changes
- Ensures that all technical equipment is installed and maintained according to the suppliers specifications and is qualified according to current regulatory requirements as required (i.e. all equipment used in GMP manufacturing).
- Makes sure that all technical equipment required is available and utilized in the most effective way.
- Serve as a point person for internal and external GMP audits
- This position may require domestic and International travel (10% or less)
Required Education and Experience
- B.S. or M.S. in molecular biology, biology, biochemistry, or other similar life science area
- 15+ years of proven pro-active management experience at a medical device or in-vitro diagnostics (“IVD”) manufacturer
- A Black Belt Six Sigma certification is an asset
- Comprehensive understanding of and a proven experience with GMP, GLP, GCP and GDP compliance
- Proven experience in leading a manufacturing organization, taking responsibility and making risk based decisions.
- Ability to work in a very dynamic environment with tight timelines, being able to shift priorities as required.
- Able to work efficiently in a highly collaborative, team oriented environment with internal teams aiming to continuously improve the overall efficiency and quality of the work performed.
- Excellent attention to detail as well as excellent communication and organization skills.
- Previous experience managing complex projects in a highly matrixed environment is desirable.