Bioanalytical testing - indian market.
Looking for an expert who can share the insights on the current dynamics of the indian market for bioanalytical testing in terms of technology, regulations and the cost saving opportunities.+3 Other Responses
Clinical Laboratory Operations
Vice president of clinical operations
purpose of position:
provides leadership for all functions and initiatives to deliver laboratory services in a timely and cost effective manner while ensuring company strategic goals are met for quality and safety, service excellence, growth, and operating efficiency.
• accountable for determining resource needs, and hiring and overseeing qualified staff in offices as part of the patient testing division. This includes staff responsible for carrying out day to day tasks of running laboratory operations, research and development, informatics, time lines, budgets, and overall clinical lab site management.
• ensure quality standards are met that 1) comply with clia and ny state standards.
• ensure effective collaboration of cross-functional activities and teams with other functional groups.
• provide status reports on metrics associated with deliverables in terms of quality, productivity, budgets, and time lines. Make suggestions and demonstrate best efforts in areas of cost- and time-effectiveness in all departmental activities as well as others in which company is engaged.
• represent company well to clients, collaborators, partners, and vendors.
• ms or ph.D. In medical laboratory science, business, healthcare administration, or related field.
• minimum of ten years progressive experience in clinical laboratory operations or three years progressive management experience in integrated clinical or reference laboratory
• extensive knowledge of analytical chemistry, molecular biology and genetics from a methods and quality control perspective
• extensive knowledge of modern principles and practices of instruments and methods used in the collection and analysis in laboratory operations
• extensive knowledge of policies, practices and procedures applicable to laboratory operations
• in-depth experience in quality assurance programs
• strong project management skills; experience in lean/six sigma a plus
• strong verbal and written communication skills, with the ability to communicate successfully with customers, executive leaders and staff
• ability to plan, direct, and coordinate the work of professional and technical staff in a manner conducive to high technical standards, efficiency and performance
• ability work effectively in a team environment and to engage managers and employees in a culture of growth, respect, knowledge and ownership of quality service+4 Other Responses
Quality Control Director
Oversee day to day operations of the quality control, document management, raw materials and stability groups. Works closely with managers to ensure testing operations are performed, including capacity management, metrics and execution of testing. Maintains rigorous quality mindset and advocates strict adherence to compliance practices within the testing labs and facility. Possess scientific skills in the specific science area and a strong working knowledge of the technical, usp compendial testing, and current good manufacturing practice (cgmp) compliance requirements for in-process, raw materials and product quality testing. Remains current regarding product quality testing needs for biosimilars and works with the technical teams to develop / modify assays to meet requirements. Ensures that appropriate records are maintained according to and in compliance with fda guidelines for biosimilars, usp, glp, cgmp, code of federal regulations (cfr) and/or points to consider (ptc) guidelines, ich guidelines, and sops. Works closely with the analytical research and development team to receive and validation of new assays and technologies, as well as existing assays. responsibilities:
ensures quality control testing is scheduled and performed develops and manages to operational and performance metrics supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems conducts employee performance appraisals in a timely and objective manner may act as study director for assigned assays and assumes all associated responsibilities interacts with other functional groups to discuss project planning and testing issues works with the analytical research and development team to provide strong in-house guidance on science and technology interacts with internal staff to identify assays requiring further improvement or development responsible for appropriately conducting assays in accordance with cgmps assures that laboratory personnel are following all company sops and safety rules prepares and revises technical documents (laboratory protocols, change controls, oos investigations, capas, sops, etc.) assures that test batch records and deviations, oos results, qa audits and other paperwork are completed according to cgmps and company sops
ph.D. In biochemistry/analytical chemistry with 10 years or bs or ms with 15 years quality control industry experience must have 8 or more years of experience with proteins and antibodies knowledge of cgmp and biosimilars guidelines is desirable ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required ability to evaluate technical data and write technical documents ability to use judgment as dictated by complexity of situation ability to work under limited supervision and to handle problems of a difficult nature ability to accomplish the described duties through the use of appropriate laboratory equipment (i.E. Biohazard hood, centrifuge, incubator, and autoclave) and computer equipment and software. (i.E. Microsoft word, outlook) +40 Other Responses