Job Summary: Under general supervision and as a member of a Scientific Affairs team, independently leads/executes research, scientific, technical programs, projects and/or experiments of blood Lab. Develops procedures, programs and strategies to establish the validation/verification protocols and writing the reports and procedures to comply with international regulatory and standard requirements.
Essential Duties:
- Developing procedures, programs and strategies to ensure FDA, AABB, EU and ISO requirements.
- Standardize lab procedures globally within the organization.
- Independently lead laboratory operations. Work to complete a variety of tests, analyses, or production and research activities involving chemical, biochemical and biological samples, specimens, and products.
- Provide protocol support for global laboratory sites.
- Establish capabilities and cost matrix for laboratories.
- Supports 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. Generate position statements on specific topics of Company interests.
- Reviews physical and equipment requirements for the laboratory. Regularly assesses short and long-term needs and prioritizes equipment purchases.
- Foster communication and collaboration among global laboratories.
Other Duties and Responsibilities:
- Maintains general knowledge of industry and Company regulatory and scientific quality standards and applies this knowledge to the completion of all projects.
- Develops and maintains pertinent documentation and procedures for the technology area according to industry, vendor, and company standards.
- Actively involves in laboratory inventory management, quality assurance programs and overall laboratory management.
- Familiarity with GMP/GLP practices and ISO standards for blood bags.
- Demonstrates required competencies and grow in the Leadership Competency Model.
Minimum Qualification Requirements:
Education: Masters in any Life science stream or PhD in any Life science stream
Experience: Minimum 5+ years of experience in industry/clinical/research laboratory settings for post graduate candidates. 1 year (preferred) experience in industry/clinical laboratory settings for Ph D candidates.
Skills:
- Ability to develop knowledge in chemistry, biological, environmental, or engineering sciences as they relate to the technical area of the business.
- Ability to analyze problems limited to moderate levels of complexity and assist in the design and implementation of solutions.
- Proficient in molecular biology and biochemical techniques. Extensive experience with flow cytometer and cell culture (mandatory).
- Deep understanding of technical principles in assigned areas.
- Demonstrated knowledge of Microsoft packages, statistical operations, and analysis.
- Demonstrated experience in science writing.
- Good working knowledge of good laboratory practices.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Patience, decisiveness and meticulousness.
- A desire to contribute to patient care and treatment.
- A responsible and mature approach to their work.
- Accuracy, with good attention to detail.
- A systematic approach to tasks and the ability to follow instructions and set procedures.
Physical Requirements: Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
About the Company: Terumo Penpol is part of Terumo Group and is headquartered in Thiruvananthapuram, Kerala. As India’s largest blood bag manufacturer, we provide a comprehensive range of blood collection, storage and processing solutions for blood centers, hospitals and therapeutic apheresis centers in India and abroad.
Equal Employment Opportunity: Terumo Blood and Cell Technologies is an equal employment opportunity employer and welcomes applications from diverse candidates.