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Manager, Manufacturing Upstream

Location Novato, California



The Manufacturing Manager is responsible for an assigned area within a plant (Upstream). 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 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


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


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


  • 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


  • 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


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


  • B. S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.


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.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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