at Terumo BCT
Posted on Sep. 28, 2016
Terumo BCT is currently seeking qualified candidates for the position of Manager, Laboratory Science, which is responsible for managing a staff of scientists, technicians, and technical operators. This person will direct the priorities for product development and Innovation and Development (I&D) functions. This person will also develop policies, procedures, programs and strategies to ensure BSL2 compliance with FDA and ISO requirements and define long term strategy for global laboratories within the organization.
* Manages and provides leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
* Develops policies, procedures, programs, and strategies to ensure BSL2 compliance with FDA and ISO requirements.
* Define long term strategy for global laboratories within the organization.
* Standardize Lab procedures globally within the organization. Provide protocol support for global laboratory sites.
* Identify and implement appropriate surveys and/or proficiency testing programs.
* Establish capabilities and cost matrix for laboratories
* Working with management, develops preliminary section budgets, goals, objectives, and operations that will be integrated into the full department budget.
* Identifies and leads departmental programs to improve productivity, quality, customer service, costs, etc.
* Develops and maintains systems for tracking projects and continuous improvement activities.
* Adequately participates in and supports the problem-solving needs of operating groups for all areas of the company and the development of new products.
* Preparation, support, and resolution of internal and external laboratory audits. Generates position statements on specific topics of Company interests.
* Communicates performance expectations and business and corporate policies to section staff and others. Ensures accurate and complete associate records are maintained within the section.
OTHER DUTIES AND RESPONSIBILITIES
* May contribute as a member of the business regulatory compliance team.
* Reviews physical and equipment requirements for the laboratory. Regularly assesses short and long term needs and prioritizes equipment purchases.
* Foster communication and collaboration among Lakewood campus and global laboratories
* Post-launch support: understand customer issues and work with cross functional teams to resolve these issues
MINIMUM QUALIFICATION REQUIREMENTS
Master's degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. A master's degree in Hematology or related discipline is preferred.
Minimum 5 years industry experience.
* The fully performing individual will possess a minimum of five or more years of supervisory experience and industry experience.
* Demonstrated and effective leadership and managerial skills.
* Demonstrated knowledge in applicable regulations affecting areas of responsibility.
* Comprehensive knowledge of the principal chemical, biological, physical, biochemical, and/or environmental techniques as applicable to work assignments.
* Comprehensive knowledge of FDA and international regulations and requirements relevant to work assignments, GLP, IDE, PMA, 510(K), OSHA, EPA, DOT, and ISO.
* Ability to select, develop and evaluate staff.
* Ability to succeed in a team oriented atmosphere and lead team activities.
* Excellent oral presentation skills.
* Comprehensive knowledge of FDA QSR/ISO 9000.
* Understanding of applications and limitations of classical and instrumental chemical methods.
* Experienced in hematology and material biocompatibility beneficial.
* Knowledge and use of relevant PC software applications and skills to use them effectively.
* Demonstrated ability to communicate effectively both verbally and in writing.
An equivalent competency level acquired through a variation of these qualifications may be considered.
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks. As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace.