Manager, Manufacturing - Novato, CA | Biospace
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Manager, Manufacturing

BioMarin Pharmaceutical Inc.

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Location:
Novato, CA
Posted Date:
2/15/2017
Position Type:
Full time
Job Code:
12762
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Description    
       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.
           Description:  
               SUMMARY
               
               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  up to 4 supervisors and 50+ technicians, developing staff capabilities, creating a culture of safety, maintain training objectives, compliance and collaboration while implementing process improvements where applicable. The manager leads the department with responsibilities for Clinical Manufacturing, with a focus on either bacterial fermentation or downstream operations, while ensuring compliance with current Good Manufacturing Practices (cGMP), policies and safety practices. The position requires being available off shift to support operations
               
               RESPONSIBILITIES
               
               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.
               
               Leadership
                ~BIO      
                   Accountable and oversight for the daily operations of an area that requires making appropriate decisions including the trouble shooting of equipment, action to process deviations and schedule adjustments with minimal oversight
                     
                   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
                   
                   Process Knowledge
                     
                   Experience with automated process equipment and control
                     
                   Working knowledge with disposable systems, filtration, CIP & SIP
                     
                   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
                   
                   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.
                     
                   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
                   
                   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
                   
                   Business
                     
                   Experience 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
                   
                   Contribution
                     
                   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
                     
                   Provide oversight of the GMP Cleanings and gowning management of 3 GMP facilities
                   

Requirements

EXPERIENCE
                   
                   Required Skills:
                     
                   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
                     
                   Strong organizational, collaborating and communication skills
                     
                   May have in excess of 4 direct reports overseeing a group of 50+ to manage
                   
                   EDUCATION
                     
                   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.