Associate Director\/Director, GMP Maintenance and Calibrations for California Facilities and Engineering
Novato, CA
Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.SUMMARYThe Associate Director/ Director of GMP Maintenance and Calibrations reports to the Executive Director of California Facilities and Engineering (CFE). The Associate Director/Director provides strategic and tactical leadership and guidance for GMP Maintenance and calibration programs within CFE organization in support of clinical/commercial product delivery, GxP laboratory operations and warehousing at the Novato Site. A high level of initiative, energy, and motivation are key role requirements, as well as excellent leadership, technical understanding and management of complexity and effective collaboration with internal and external stakeholders.JOB RESPONSIBILTIIESResponsibilities include but are not limited to the following:• Own the GMP Maintenance and calibration programs and teams at the Novato Site• Own the development and management of department budgets and cost center• Develop, support, and continuously improve integrated working relationships with key stakeholders on site at Novato and in the global BioMarin network• Actively manage staffing, resource, and workload requirements• Define and improve maintenance strategies for campus and future campus operations.• Continue to promote a “Right First Time” philosophy in all areas of maintenance• Maintain a safe working environment by continuously promoting safety awareness, recognizing, and rectifying unsafe conditions and performing thorough investigations when accidents occur.• Lead a high performing team that maintains and champions a diverse and inclusive workplace. • Recruit, direct, coach, develop and maintain the team’s technical and interpersonal skills.• Responsible for identifying investment needs related to sustaining operations at the Novato campus and translating this into business cases to endorse future investment and long-range planning• Contribute to the asset life cycle management for the campus to maintain/replace existing equipment and implement new technologies where applicable to ensure best-in-class manufacturing operations. • Responsible for ensuring the quality and quantity of work produced, staffing requirements, and personnel management.• Drive, promote and instill a culture of asset resiliency, care and optimization.• Ensure all critical clean utilities are operated and maintained within required specifications.• Ensure the calibration program for all GMP, Safety and environmental related instrumentation and equipment is implemented in a compliant state.• Review maintenance/reliability practice and systems on an on-going basis to identify and implement improvements to reduce the overall efficiency and effectiveness of the maintenance and utility operations.• Key contributor to the site’s business continuity planning efforts.• Establish mechanisms to ensure that all suppliers / contractors used deliver to agreed specifications.• Maintain a safe working environment by continuously promoting safety awareness, recognizing and rectifying unsafe conditions and performing thorough investigations when accidents occur.• Maintain documentation and management and control systems in compliance with cGMP regulations and training instructions.SCOPE• The scope of the role applies to all buildings and facilities withing the Novato Site.• The work product from the Associate Director/Director will directly support product delivery and other programs executed in the network, will be a major driver for asset lifecycle management (LCM) strategies, and will highly impact campus operations and network strategies. • This role has both strategic and tactical planning responsibilities for the campus.EDUCATION• BA/BS/MS in engineering, life sciences or related field• Advanced degree desirable, but not requiredRequired Experience and Abilities: • Preferred 12 years of experience with the design, installation, startup, and servicing of process equipment, utility systems in the biotech industry. • At least 10 years GMP/GCP compliant Biopharma operations experience required• Exceptional communication skills required, as this position will require interaction at all levels of the organization. • Demonstrated ability to partner with other functional groups to achieve business objectives required.• Creative problem-solving skills.CONTACTSLaboratories, Manufacturing, Material Operations, Regulatory, Quality, Supply Chain Supply and Demand Planning, Finance, Compliance, TOPS Program Management Group, IT, BPI/BPE, Human Resources, Network Strategy Teams, MSAT, Business Operations, Legal. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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