13 days old

Senior Scientific Advisor

Baxalta U.S., Inc.
Social Circle, GA 30025
  • Job Code
    R0036948

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Job Description

The position will support the manufacturing ramp-up of a new, state-of-the-art plasma fractionation facility that will bring Takeda additional capacity for production, purification, and fill and finish for its biologic medications. This position is a technical expert position responsible for providing support and develop site initiatives for process robustness and yield improvements for all manufacturing processes conducted at the Social Circle manufacturing site. In addition, this position will support DOE designs and small scale execution of DOE experiments. The position will also support critical investigations and projects impacting multiple manufacturing areas.

This position will also be required to review the overall manufacturing process of the plasma Fractionation work stream for both Albumin and Gammagard liquid manufacturing, as well as the down stream.

Job Function:

  • Will lead teams consisting of different groups (Manufacturing Sciences, Process Engineering, Quality Operations, etc.) in development and implementation of process related projects.
  • Ensure compliance with regulatory and global standards for process improvement changes.
  • Will be a technical expert in plasma manufacturing operations in both upstream and downstream process, able to teach, mentor, and help develop SMEs for specific areas of the manufacturing process.
  • Will provide leadership in development of new ideas, products, processes and techniques to meet ramp up to full capacity.
  • Will support and lead strategic projects for network capacity projects and process technical transfers for different products to the site.
  • Serve as tribe lead for Factory of the Future initiatives.
  • Will lead and provide direction on critical technical process issues
  • Responsible for evaluation of manufacturing process and build a process road map to build process robustness and optimal efficiencies while maintaining maximum compliance.
  • Participate in all process projects at the development and design phases and ensure all required process change requirements are covered.
  • Work with pilot scale laboratories to develop and execute DOE studies to support site and global plasm OpU initiatives.
  • Support critical investigation and projects impacting multiple manufacturing areas as technical expert.
  • Must have excellent written and oral communication skills.
  • Participate in regulatory submission reviews and ensure correct and required information is provided.

Technical/Functional (Line) Expertise

  • Must be a technical expert in plasma manufacturing operations in both upstream and downstream process, able to teach, mentor, and develop SMEs for specific areas of the process.
  • Must have excellent written and oral communication skills.
  • Demonstrated ability to understand and help resolve complex process problems.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Requires a minimum of a bachelors degree, preferably in science, engineering or other related technical field. Advanced degree is preferred.
  • 15+ years of experience in plasma derived therapies with experience in product development required

This posting excludes CO applicants

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Sponsored by:
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Senior Scientific Advisor

Baxalta U.S., Inc.
Social Circle, GA 30025

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