Manager, Manufacturing
- Employer
- BioMarin Pharmaceutical Inc.
- Location
- Novato, California
- Start date
- Oct 8, 2021
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay, Best Places to Work
Job Details
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.
The Manufacturing Manager is responsible for an assigned area within a plant with oversight over either Upstream or Downstream operations. Through collaboration with support groups, the manager is responsible for ensuring accurate and well managed transfer of process changes/improvements to floor operations, integrates best practices, where appropriate, into manufacturing and oversees the planning, implementation and execution of manufacturing operations for new and/or existing products and technologies in a cGMP environment. The Manufacturing Manager is also responsible for leading a department of supervisors and operations staff, developing staff capabilities, creating a culture of safety, while maintaining training objectives.
Accountable for plant activities, monitoring processing, maintenance of production equipment and facilities in the manufacturing areas, overseeing complete documentation of all required production activities and ensuring compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices. The position may require off hours support as required.
Processing
- Control and involvement of operations and activities that occur in an assigned area within manufacturing.
- Ensure consistent product quality through implementation of effective systems and collaboration with key support groups (QA, MSAT, ENG, FAC, etc.)
- Broad technical knowledge in area of responsibility and provides technical instruction on new/improved processes to appropriate audiences, primarily Manufacturing personnel
People
- Involved in hiring and monitoring 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
Quality
- Own and approve deviations and change requests within assigned work area.
- 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
Strategic Influence
General Look-Ahead: 1 year
- Monitor and manage all aspects of performance in an assigned manufacturing area
- Translates business plans and organizational goals into actionable objectives
- 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
Contribution
- Accountable for operations and results of a assigned area in production plant
- Establishes and influences operations policies with focus on alignment across manufacturing plants when appropriate
- Communicate, interact and influence with peers and plant leadership
Leadership
- 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
- B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
- 8+ years of directly related industry experience, including at least 4+ years with proven leadership
- Ability to independently manage work, actions and expectations is essential
Company
BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.
Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.
Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.
- Website
- https://www.biomarin.com/
- Location
-
California
United States
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