Abbott Senior Manager, Research Facility in Sylmar, California
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Our location in Camarillo, CA currently has an opportunity for a Sr Manager, Research Facility.
Acting independently and within broad policy, manages pre-clinical research activities in compliance with applicable regulations. Oversees facility to ensure proper care is taken to maintain test subjects according to federal regulations as well as the guidelines provided by the United States Department of Agriculture (USDA), the attending management, and the Code of Federal Regulations (21 CFR) Part 58. Remains current on developments in field(s) of expertise. Sets goals and ensures that they are met. Independently exercises discretion and sound judgment in planning, organizing, and performing work. Monitors performance and reports status. Identifies and evaluates the most effective, cost efficient, and best business practices to execute processes. Promotes the process of continuous process/quality improvement and coordinates solutions for technical and personnel issues. Troubleshoots relatively complex problems and issues. Ensures employee compliance with Sponsor policies, procedures, and practices.
WHAT YOU’LL DO
Responsible for attracting, hiring and retaining diverse, highly qualified staff and for providing career coaching, growth and personal development. Accountable for the development of staff. Accountable for the performance of subordinates or the work output of managed subcontractors. Maintains a safe working environment and a strong customer focus. Models optimum leadership competencies to inspire an energized, empowered and accountable work force and ethical behavior. May assist in negations that detail agreements with test subject facilities for contract usage.
Manages the use of test subjects involved in medical research, including the following responsibilities: maintains standards for ethical and humane treatment of test subjects as dictated by the management; advises biomedical and clinical engineers as to proper use of test subjects in research experiments; maintains parameters and guidelines for all invasive type procedures; and acts as liaison between test facility and the Sponsor.
Manages (for GLP and non-GLP studies) and/or performs (for non-GLP studies) non-GLP technical activities including, but not limited to, the following: all surgical tasks, including medical device implants, experimental surgical procedures, and explants; ; euthanasia; data retrieval for test systems; documentation of study activity and data; and maintaining and acquiring all necessary equipment required to perform experimental tests.
Fulfills the role of Testing Facility Management (TFM) as required by the Code of Federal Regulations (21 CFR) Part 58.
Acts as liaison with development groups and pre-clinical research, assisting in design and development of new products predicated upon research, and advises as to effectiveness of new designs for future application to human evaluations.
May perform (for non-GLP studies) and/or oversees (for GLP and non-GLP studies) the retrieval and organization of all data generated by test systems ensuring availability as needed.
Conducts special analyses and projects as required
Performs departmental administrative duties including space and equipment acquisition, problem resolution, communication and policy implementation.
Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that may affect medical research activities. Maintains knowledge of and consults on current/pending regulations through a review of key literature, trade journals, professional associations, and by attending conferences.
Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence, but escalates items as appropriate.
May fulfill GLP archivist duties if required.
Performs related duties, on occasion, as assigned or required.
Acting independently and within broad objectives, is accountable for ensuring that the research facility and related activities comply with current regulations. Accountable for the successful completion of assignments that have critical impact on the department and the Division as a whole. Identifies relevant sources of information and utilizes them to make decisions. Exercise considerable judgement and latitude in determining objectives and approaches to assignments. Directs and is accountable for the conducting of all research in an effective and efficient manner, and in compliance with all applicable regulatory and ethical requirements. Accountable for conducting performance evaluations, training, motivation, counseling, and discipline to employees managed as appropriate. Also accountable for providing technical guidance to staff as assigned. Has authority to make resource, schedule and performance commitments for assigned efforts and is accountable for results. May provide substantial input to research standards, practices, procedures, and policies. Decisions and recommendations have critical impact on significant organizational projects or operations. Acts as mentor/coach to staff to develop solutions and resolve complex problems that could significantly impact organization budgets or commitments. Resolves complex problems and develops original solutions.
Internal: Interfaces primarily with Clinical Research and Research and Development personnel at various levels. May have internal contacts with management, Marketing, Manufacturing, Quality, Sales, and customers to gather or convey information related to studies. Accomplishes results through direct staff and teams. May participate on one or more non-GLP project teams; provides supervision to a group of facility maintenance employees. Provides leadership for development of employee competencies and recommends goals and priorities for the department. Ensures the development of high-performance teams and effective working relationships with other organizations. Mentors less experienced staff members; may provide guidance to and collaborates with other professionals. Supports peer reviews.
External: Interfaces with vendors, U.S. Department of Agriculture (USDA) inspectors, Food and Drug Administration (FDA), city and state agencies, and other agency representatives regarding regulatory issues, and consultants. May also interact with physicians, scientists, and other researchers.
Works in a research laboratory that is compliant with the International Organization for Standardization requirements and Good Laboratory Practices (GLP). Good lighting. Quiet to moderate noise level. Minor amount of exposure to fumes or airborne particles and toxic/caustic chemicals. Exposure to possibility of electrical shocks. Works with sensitive precision equipment that requires special handling.
Activities require a significant amount of time sitting at a desk, standing at a lab, operating or dissecting table, and some walking relative to interaction with staff, other departmental personnel, and a furtherance of duties and responsibilities. Light effort related to moving, lifting and using office supplies and standard office items. Performs tasks which regularly require good correctable vision and hand/eye coordination for lab observations (correctable). This position requires periodic travel between Company facilities, to regulatory agencies, conferences and seminars by automobile and commercial transport.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor’s degree in Veterinary Sciences, Biology, a related field, or equivalent
A minimum of ten plus years of progressively more responsible research test subject care and experience, including demonstrated knowledge of Good Laboratory Practices (GLP) standards and care requirements.
Demonstrated working knowledge of test subject handling, surgery and operating room techniques is also required, plus some background or at least acquired knowledge in the field of cardiology.
Familiarity with multichannel records, electrocardiogram (EKG) interpretation, radiological exams, video technology, and photography.
Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position, including the ability to map task interdependencies, prioritize such tasks, and develop monitor and live within budgets as well as the demonstrated ability to forecast major milestones.
Must be skilled at delegation, follow-up, and team building as well as a history of being able to multi-task and meet multiple project schedules on time.
Must be able to work cooperatively and productively with others. Advanced evaluation skills, originality, and ingenuity are musts as are demonstrated verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential; the ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, polices, and rules is also required.
Demonstrated personal computer skills including spreadsheet skills, word processing, data base management and other relevant applications.
Ability to travel, approximately 25%
Exceptional leadership skills, provide mentoring and development to direct reports and able to work effectively through the direct report to accomplish goals and objectives.
An advanced credential in a relevant business or management discipline/concentration (i.e., MA, MBA) is highly desirable.
Professional certification or designation.
A practical understanding of cardiac rhythm management technology.
Academic or in-house courses in project management, leadership, training, Continuous Improvement (CI), cycle time improvement, and various technical applications as noted above.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development , with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
*Learn more about our benefits that add real value to your life to help you live fully: * www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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