Sr. Manufacturing Support Manager in Research Triangle Park, North Carolina |Careers at NC RTP FDBU Office


Requisition ID 2021-15992
Category Manufacturing
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
Overview

We are 'Advancing tomorrow's medicines' and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow's medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

The Senior Manufacturing Support Manager is recognized as subject matter expert concerning buffer/solution prep and weigh/dispense operations. Ensures delivery of production execution schedule and adherence to daily and weekly schedule. Must be able to identify and communicate improvement opportunities and results. Initiates and oversees implementation of operational process improvements, new technology or/and modifications to existing technology aimed at enhancing safety and/or quality, cost reduction, efficiency improvements, and minimization of downtime/maximization of asset and resource utilization and quality/safety enhancement. Must be able to identify and communicate improvement opportunities and results. Provides feedback to Manufacturing Leadership regarding intra- and inter-departmental ways of working and potential improvement, alignment and harmonization opportunities. Coordinates and leads training across shifts. Identifies operational needs for special projects, ensuring site/divisional linkage is achieved. Mentors and trains new managers and other new departmental employees.


External US

We are 'Advancing tomorrow's medicines' and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow's medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

The Senior Manufacturing Support Manager is recognized as subject matter expert concerning buffer/solution prep and weigh/dispense operations. Ensures delivery of production execution schedule and adherence to daily and weekly schedule. Must be able to identify and communicate improvement opportunities and results. Initiates and oversees implementation of operational process improvements, new technology or/and modifications to existing technology aimed at enhancing safety and/or quality, cost reduction, efficiency improvements, and minimization of downtime/maximization of asset and resource utilization and quality/safety enhancement. Must be able to identify and communicate improvement opportunities and results. Provides feedback to Manufacturing Leadership regarding intra- and inter-departmental ways of working and potential improvement, alignment and harmonization opportunities. Coordinates and leads training across shifts. Identifies operational needs for special projects, ensuring site/divisional linkage is achieved. Mentors and trains new managers and other new departmental employees.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Employee Development/People Management
    • Personnel Management of direct reports (Buffer Prep Production Manager, Weigh and Dispense Production Manager, Buffer Prep Inventory Coordinator) and the employees within those areas;
    • Work off shift hours as necessary or assigned/needed. This position supports staff working 7 days per week and up to 16 hours per day. Be available to consult via phone, zoom, and in person, when needed;
    • Communicates with staff directly, with use of Tier 1 board, Tier 2 board, and Shift Plan
    • Coaches team in a learning culture with the goal of achieving employee empowerment and ownership;
    • Recognizes and addresses employee performance;
  • Production Performance Ownership
    • Conduit between manufacturing production operations and support operations, operations leadership, readiness, planning and support functions and manufacturing execution teams;
    • Assist with management to effectively schedule areas and personnel to maintain production needs;
    • Complete periodic reviews of documents, as needed;
    • Able to effectively communicate across organizational levels with internal and external clients and partners;
    • Participates in department and site level OpEx projects;
    • Interaction with groups such as Supply Chain, Materials Management, EHS, Maintenance, Metrology, Manufacturing Technology & Support, Quality Control, and Quality Assurance (QA);
    • Assists in performing Equipment and Room Coordinator tasks, as needed;
    • Hosts manufacturing Tours for clients, audits, corporate visitors;
    • Represents Buffer/Solution Prep and Weigh/Dispense at planning & scheduling meetings;
    • Assists team with development objectives and ensures alignment with site and department goals;
    • Responsible for ensuring suites and associated documentation and equipment is always inspection ready;
  • Compliance
    • Manage deviations, CAPAs, and audit response within Trackwise, on a timely basis related to the buffer/solution prep and weigh/dispense areas.
    • Coordinates equipment calibrations and maintenance, as necessary
  • Any other activities, tasks and duties identified as required

BACKGROUND REQUIREMENTS:

Preferred Education, Experience and Skills - Minimum Requirements:

  • BS/BA (science preferred) and 5+ years of experience in a cGMP (pharmaceutical/manufacturing environment OR AA (science preferred) and 7+ years of experience in a cGMP (pharmaceutical/manufacturing) environment OR 10+ years of experience in a cGMP (pharmaceutical/manufacturing) environment in lieu of a degree
  • Good working knowledge of cGMP requirements, including documentation and regulatory requirements
  • Due to the various interactions with external and internal groups, interpersonal and organizational skills are essential attributes. Must have the ability to work in a cross-functional team environment.
  • Experience with the Microsoft Office Suite (Word, Powerpoint, Excel) required. Experience with SAP, PAS-X, DCS/Unicorn/Pi, and/or Trackwise preferred.
  • Physical Ability: ability to walk, climb stairs, crawl, kneel and lift, frequently throughout the shift, up to 12-hours.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 - 130 and Export Administration Regulations in 15 C.F.R. Part 730 - 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail (see application details).

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Posted
10/02/2021
Salary Range
$95,000.00 - 149,000.00
per Year
Salary range estimated by
Location
Durham, NC 27709, US
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