Area Lead, Downstream Manufacturing (Swing/Night Shift)
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 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.
-Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight
-Accomplishes tasks through direct and effective coordination
-Provides direction and hands-on training for staff
-Supports the management of staff
-Lives department values and sets the standards for others to operate
-Fosters an environment of compliance, strong work ethic and ongoing learning
-Ability to take responsibility for complex projects
-Effective interaction with peer Leads across manufacturing to create alignment and improvement
-Partners with support groups (Facilities, Validation, Quality, Automation, and Instrumentation) to complete scheduled activities
-Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
-Ability to troubleshoot, identify issues and support resolutions with technical groups
-Required to perform ongoing operational tasks in respective work area
-Uses scientific thinking and decision making in daily work
-Proven experience with relevant process, theory and equipment
-Experience with process automation and functionality
-Assist with review and approval of documentation including Batch Records and logbooks
-Provide feedback and/or suggested changes to operational procedures
-Assist in the incorporation of new technologies, practices and standards into procedures
-Capable of writing and reviewing process documents
Quality and Compliance
-Complete understanding and adherence to cGMP’s as related to commercial operations
-Support the closure of manufacturing discrepancies and change requests
-Experience with business systems (Process historian, LIMS, Trackwise, ERP, MES, etc.)
-Bachelor’s degree in science related area or engineering or Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
WORK ENVIRONMENT/PHYSICAL DEMANDS
-Consists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
-Independent ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
-May require work around loud equipment.
-The use of personal protective equipment will be required.
- Shift will start as Mon-Fri 1400-2300, with planned transition to Wed-Sat 1800-0700 in April 2023.
-Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
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.