Manufacturing Manager (Cell Culture) - United States
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BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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.
BioMarin’s Novato commercial manufacturing operations produce recombinant enzyme replacement proteins for rare genetic disorders. The manager will be responsible for leading a team of Supervisors and 30+ operators, developing staff capabilities, creating a culture of safety, maintaining training objectives, compliance and collaboration while implementing process improvements where applicable. The manager will lead the upstream cell culture production starting from seed production to large scale production. The manager will be responsible for daily upstream operations and ensuring compliance with current Good Manufacturing Practices (cGMP), policies and safety practices. The position requires oversight of 24/7 activities.
The Manufacturing Manager is responsible for an assigned area within a plant (Upstream, Downstream or Process Services). Collaborates with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Integrates best practices, where appropriate, into manufacturing. Oversees the planning, implementation and execution of manufacturing operations for new and/or existing products and technologies in a cGMP environment.
Accountable for the daily operations of an area that requires making appropriate decisions including the trouble shooting of equipment, response to process deviations and schedule adjustments.
Accomplishes tasks through direct & effective management of staff
Interact with department leaders to ensure production objectives are met
Accomplishes results through professional staff and/or employees
Sets project timeframes and priorities based on objectives with effective tracking and management of progress
Provides guidance and technical advice and becomes actively involved as required
Manages a team of supervisors and/or professionals
Contributes to the standards around which others operate
Experience with Cell Culture processes (perfusion systems is a plus)
Experience with automated process equipment and control
Working knowledge with disposable systems, filtration, centrifuge
Experience with troubleshooting and problem solving with process and equipment
Experience with Buffer and Media operations
Support the closure of manufacturing discrepancies and change requests
Knowledge and experience in all aspects of GMP manufacturing
Ability to troubleshoot, identify issues and support resolutions with technical groups
Effectively communicates relevant information with team & department
Ensure consistent product quality through implementation of effective systems and collaboration with key support groups (QA, MSG, Eng, Fac, etc.)
Broad technical knowledge in area of responsibility for and provide technical instruction on new/improved processes to appropriate audiences, primarily Manufacturing personnel
Involved in hiring process to maintain staffing levels
Provides effective leadership through:
Managing performance and expectations of direct reports, team and self
Manage performance issues, development and policies
Ensure the use of safe and compliant work practices and behaviors
Own and approve deviations and change requests within assigned work area.
Initiate and own required Corrective and Preventative actions and lead change control actions
Manage required actions with department and collaboration with support groups to meet quality commitments and established timelines
Provide technical expertise to resolve manufacturing issues. Interact with support groups to ensure targets are met and product and process comply with cGMPs
Owner of Standard Operating Procedures and Batch Records
Ensure staffing levels and skill sets are maintained and training is in compliance
Complete understanding and adherence to cGMP’s as related to commercial operations
Lead or oversee teams responsible for drafting standard operating procedures
General Look-Ahead: 1 year
Develop manufacturing flows and process steps in production area
Influences approach for operations at campaign and daily execution
Adheres to and executes policies and guidelines that directly affect work activities
Champion self-initiated projects and drive area of control within context of defined priorities
Experience with various business systems (Process historian, CMMS, LIMS, TrackWise, ERP, MES, etc.)
Lead trending and communication of key department metrics
Identify and drive opportunities for process & business optimization
Accountable for operations and results of a assigned area in production plant
Ability to independently manage work and assigned projects
Responsible for projects that span multiple functional areas
Receive assignments in the form of objectives with goals and steps to meet as defined
Work is reviewed by management to measure meeting of defined objectives
Establishes and influences operations policies with focus on alignment across manufacturing plants when appropriate
Communicate, interact and influence with peers and plant leadership
8+ years of directly related industry experience, including at least 4+ years with proven leadership role
Ability to independently manage work, actions and expectations is essential
Experience with process development, process transfer, validation and multi-product operations
Experience with startup of new facility or processes
Strong organizational, collaborating and communication skills
May have in excess of 4 direct reports overseeing a group of 30+ to manage
B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
WORK ENVIRONMENT/PHYSICAL DEMANDS
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.