Job Description
Who We AreFor 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 CultureOur 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 \u2013 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\u2019s 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\u2019s 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\u2019 lives. KEY RESPONSIBILITIESLeadershipAccountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversightAccomplishes tasks through direct and effective coordinationProvides direction and hands-on training for staffManagement of staffLives department values and sets the standards for others to operateFosters an environment of compliance, strong work ethic and ongoing learningContributionAbility to take responsibility for complex projectsEffective interaction with peers across manufacturing to create alignment and improvementPartners with support groups (Facilities, Validation, Quality) to complete scheduled activitiesProcess KnowledgeStrong knowledge and experience in all aspects of relevant process theory, equipment and complianceAbility to troubleshoot, identify issues and support resolutions with technical groupsRequired to perform ongoing operational tasks in respective work areaUses scientific thinking and decision making in daily workTechnical CompetencyProven experience with relevant process, theory and equipmentExperience with process automation and functionalityAssist with review and approval of documentation including Batch Records and logbooksTechnical documentationProvide feedback and/or suggested changes to operational proceduresAssist in the incorporation of new technologies, practices and standards into proceduresCapable of writing and reviewing process documentsQuality and ComplianceComplete understanding and adherence to cGMP\u2019s as related to commercial operationsInitiate and own required Corrective and Preventative actions and lead change control actionsSupport the closure of manufacturing discrepancies and change requestsCurrent understanding of FDA and EMEA guidelines, cGMP's for Manufactured Drug ProductsBusinessExperience with business systems (Process historian, LIMS, Trackwise, ERP, MES, etc.)Support trending and communication of defined department metricsIdentify and drive opportunities for process & business optimizationTranslates company and department goals into actionable objectives for self and staffPREFERRED EXPERIENCE AND QUALIFICATIONS-6 years of directly related industry experience, including at least 2 years with proven leadership role-Technical expertise in large scale processing with various complex cell culture platforms-Experience with cGMP's in a biologics manufacturing facilityOther duties as assignedShift Details:\u00A0Thu-Sat, every other Wed, 1800-0700 (Night shift) 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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