Manufacturing Planning Associate

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 Manufacturing Planning Associate assists the Manufacturing team in maintaining the short-term outlook production schedule per the revenue forecast and given operational parameters in manufacturing.  The primary output of the position is the central production schedule for RTP.  The schedule is frequently reviewed for opportunities and adjustments based on inputs from Manufacturing readiness, supply chain and program management.  Clear concise updates on the schedule changes are required, and are tailored to the audience/internal customers (program managers, finance, maintenance or manufacturing).

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Assists the Senior Manager, Manufacturing Planning in developing and maintaining the master Manufacturing Production Schedule and Asset Plan, for a 3 – 6 month outlook that fulfills both contracted requirements and FDBU revenue requirements.
  • Works with Supply Chain to ensure materials and records demands are understood to meet production schedules.
    • Creates and maintains the templates needed for weighing and dispensing of batch and formulation records
  • Coordinates major maintenance activities (planned or emergency) affecting the RTP facilities or equipment in conjunction with the Manufacturing Facilities Coordinator, making the work time and return to service time visible.
  • Coordinates qualification, requalification and water run activities with MTS that affect RTP facilities or equipment, making the allotted time visible
  • Identify and communicate manufacturing resource (people, equipment, and facilities) gaps for the business pipeline to Manufacturing leadership.
  • Maintains the Manufacturing Planning Equipment Database
  • Creates and maintains the MFG Tier 2 board tier sheets, placards, and materials
  • Participates in team projects related to Operational Excellence
  • Performs other duties as assigned to support Manufacturing Planning

BACKGROUND REQUIREMENTS:

  • 1+ years’ experience in the biotechnology or pharmaceutical industry is preferred
  • Bachelor Degree with a focus in business, engineering or science.
  • Ability to coordinate, facilitate and organize resources.
  • Ability to develop strategic relationships; strong verbal and written communication skills.
  • Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Access
  • Mathematical and reasoning ability.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to work effectively under extreme pressure to meet deadlines.
  • Strong organizational skills with the ability to handle multiple activities simultaneously.
  • Detail oriented and accurate.
  • Proven success in leading complex projects and bringing them to conclusion.
  • Ability to persuasively champion strategic ideas, as supported by sound rationale and analysis, and drive change within the organization.
  • Strong knowledge of concepts, practices, and procedures related to the biotechnology industry.
  • Strong analytical, interpersonal, presentation and problem solving skills.
  • Ability to analyze, break-down, and interpret a wide variety of information and form a strategic opinion while addressing the operational implications.

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.

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.

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