Associate Director, QC Analytical
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. Role SummaryThe Novato Quality Control Analytical Director is responsible for direction of the GMP Quality Control laboratory providing analytical support to the Novato production site. This function performs Quality Control testing that supports manufacture and release and stability of drug substance, intermediates, and drug product from CHO cell and bacterial cell production platforms as well as viral vector platforms. In addition, testing support of Contract Manufactured materials is performed. This role is responsible for the management of the analytical testing in support of: • Test and release of Bulk Drug Substance and Drug Product • Test of stability samples. • Testing and support for critical reagents and reference standards. • Support of CMO testing. • Product Complaint support • Implementation of new analytical methodsThis position reports to the Quality Control Site Head and is a member of the Novato Site QC Leadership Team. The successful candidate ensures functional objectives are aligned with company goals and regulatory expectations.Role Responsibilities• Provide technical expertise and leadership for the performance of analyses of Manufacturing and Clinical Manufacturing In-Process samples under cGMP to meet specified timelines. • Directly supervise QC Staff. • Collaborate with cross functional teams on key site and Global programs. • Implement the concepts of Operational Excellence and deploy appropriate systems and processes to enable the efficient operation of a GMP laboratory supporting multiple platforms and modalities • Critically analyze and assess data. • Prepare protocols, summaries, and reports. • Act as technical resource. • Develop leadership of the group. • Maintain the laboratory in an inspection-ready state. • Direction of investigations. • Author, review and approve documents such as standard operating procedures, protocols, reports and trackwise records • Interface with other BioMarin departments (Regulatory Affairs, Quality Assurance, Facilities, etc.) and contractors as necessary. • Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives • Develop and Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance • Lead and implement initiatives that add value to the QC and site operations • Optimization, troubleshooting and lifecycle management of analytical test methodsEducation Required• PhD with at least 4 years of experience in a relevant functional area • M.S. with at least 6 years of experience in a relevant functional area • B.S. with at least 8-10 years experience in a relevant functional area (at least 2 years in Quality Control). Experience RequiredThe position requires:• At least two years in a cGMP laboratory, Quality Control experience preferred. • Demonstrate expertise with analytical methods used to assess biopharmaceutical products. • Lean Labs and, Six Sigma, and 5S experience.• Ability to work independently, managing projects and meeting established timelines. • Comfortable with directing the activities of other staff members.• Computer literacy is required. Experience with Laboratory Information Management systems (i.e., LIMS) is preferred. The position requires some technical knowledge of the following areas:• Immuno Assays• Chromatography• Spectroscopy• PCR (Polymerase Chain Reaction) based assays• Total Organic Carbon Analysis• Bioassays• Basic analytical skillsSupervisor ResponsibilityDirection and management of the managerial and supervisory leaders of the Analytical testing Quality control function. Typically 4-5 direct reports.Competencies RequiredThe position requires:• Strong leadership skills• Well developed organization skills with exact attention to details.• Excellent written and verbal communication skills.Behavioral• Accountability• Achieving Excellence• Communication• Courage / Challenge• Develop Self & Others• Judgement• Reliability• TeamworkTechnical• GMP Acumen• Critical Thinking & Evaluation • Influencing• Organizational Awareness • Performance Management • Self-KnowledgeNote: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. 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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