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Sr. Associate, Downstream Manufacturing (Night Shift)

Location Novato, California Workstyle Onsite Only
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.

KEY RESPONSIBILITIES

· PROCESS KNOWLEDGE:

o Understanding of process theory and equipment operation

o Ability to learn and operate in biopharmaceutical manufacturing processes including cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance; and perform all aspects with a broad understanding of scientific , compliance, and technical components

o Support initiatives for process optimization

o Identify and elevate processing issues and support solutions

o Demonstrated experience with automation systems (LIMS, MES, PI, etc.)

· TECHNICAL DOCUMENTATION:

o Provide feedback and/or suggested changes to operational procedures

o Assist in the incorporation of new technologies, practices and standards into procedures

o Capable of writing and reviewing process documents

· QUALITY AND COMPLIANCE:

o Understanding of cGMPs as related to Clinical and/or Commercial Operations

o Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)

· BUSINESS:

o Ability to participate on projects and contribute to outcomes

o Capability to learn and support new business systems (Track wise, ERP, etc.)

o Support trending of defined department metrics

· Other duties as assigned.




-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.

In the U.S., the salary range for this position is $ 59,400 to $ 89,200 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

About our location

Novato

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