Responsible for the oversight, planning, coordination, and supervision of technical and operational activities in the Bioassay laboratory.
Manages the Bioassay operations related to planning and management of laboratory control systems, QC programs, resources and vendor activities associated with lab operation.
Oversees the execution of testing including routine analysis and raw material testing.
Provides guidance and execute validation and technology transfer of analytical methodologies and stability programs.
Reviews and approves standards, methods and procedures for inspecting, testing and evaluating the quality of company products.
Manage QC related Quality System activities including evaluating and determining CAPA to ensure quality conformity improvement.
Ensures finished products conform to company standards and satisfy GMP regulations.
Ensures adherence to department, site and corporate SOPs and other regulatory requirements.
Accountable for the management of the Laboratory Investigation Reports and with trending data.
Responsible for the preparation of periodic laboratory and product performance reports.
Interacts with agents from regulatory agencies and participates in regulatory inspections.
Contributes to the development of the department budget and monitors expenditures.
Provides technical insight to other departments such as Material Review Board and CAPA meeting and activities as part of cross-functional management activities.
Selects, develops and evaluates personnel to ensure functional objectives are met.
Establishes operational objectives and assignments and delegates assignments to direct report managers. Objectives are reviewed to determine success of operation.
Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect.
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Develops and ensures budgets, schedules and performance requirements are met.
Erroneous decisions will result in critical delays in schedules and/or unit operations and may jeopardize overall business activities.
Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions and/or customers. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
Bachelor’s degree in a scientific discipline.
Typically 10+ years related progressive experience in cGMP/FDA regulated industry, and a minimum of 5 years supervisory experience is preferred.
Strong knowledge of basic lab testing techniques, preferably in Immunology.
Experience in conducting laboratory investigation, writing nonconformance, implementing CAPAs and initiating change controls.
Familiarity with technology transfer and building a quality infrastructure to support commercialization. Experience with validating analytical methods and processes related to instrument and laboratory management systems
Strong level of analysis skills required to evaluate and interpret data to arrive at logical conclusions. Understanding on how to apply, and/or experience with, problem solving tools (i.e. Fishbone diagram, IS/IS NOT, Kepnoe/Trego concept, 5Ms and 5 Whys)
High attention to detail, quality and compliance with strict adherence to test procedures and protocols
Ability to learn new technologies and processes quickly and to understand the technical concepts behind each assay performed.
Strong experience in applying GMP in QC lab in conformance to US/ROW standards.
Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations preferred.
Proficient in MS Office applications.
Ability to effectively negotiate and build collaboration amongst individuals.
Demonstrated ability to develop, coach, and mentor key employees.
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Comfortable ina fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
Working Conditions and Physical Requirements:
Ability to sit or stand for extended periods of time
Intermittent walking to gain access to work areas
Finger dexterity sufficient to use a computer and to complete paperwork activities
Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
Hearing sufficient to communicate with individuals by telephone and in person
Limited exposure to (2°C – 8°C); (-20°C); (-75°C); (-196°C) areas.
Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
Job performed in a lab, office, or utility (noisy) environment
Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products, OPIM (other potentially infectious materials) and chemicals while donning required personal protective materials.