Supervisor, Downstream Purification

Responsibilities

• Lead daily operations in the downstream purification area, ensuring schedule adherence and effective troubleshooting.
• Manage and provide hands-on training and direction to staff members.
• Foster an environment of compliance, strong work ethic, and continuous learning.
• Partner with cross-functional groups such as Facilities, Validation, MSAT, and Quality to complete scheduled activities.
• Review and approve technical documentation, including Batch Records and logbooks.
• Drive process and business optimization by identifying opportunities for improvement.
• Ensure strict adherence to cGMP, FDA, and EMEA guidelines.
• Initiate and own Corrective and Preventative actions (CAPA) and lead change control actions.

Requirements

• B.S. degree in Life Sciences, Engineering, Applied Physics, or an equivalent combination of education and experience.
• 4+ years of directly related industry experience.
• 2+ years of proven leadership experience in a manufacturing environment.
• Strong knowledge of cGMP, FDA, and EMEA guidelines.
• Proficiency with business systems such as LIMS, Trackwise, ERP, or MES.
• Ability to work onsite for the designated night shift (Sun-Tues, alt Wed, 1800-0700).

About the Company

BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients living with serious and life-threatening rare genetic diseases. Our Technical Operations group is responsible for creating drugs for clinical trials and scaling production for the commercial market, utilizing cutting-edge manufacturing processes to make a meaningful impact on patients' lives.