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Senior Manufacturing Sciences Technology Associate

Company: Scientific Search
Location: Rockville
Posted on: April 10, 2021

Job Description:

Senior Manufacturing Sciences and Technology Associate (MSTA).

Check out for all of our openings

Senior Manufacturing Sciences and Technology Associate needed for biologics company to provide technical support to biopharmaceutical drug substance manufacturing operations for late-stage clinical and commercial programs. The position will work in partnership to support technology transfers, process and equipment validations, and routine manufacturing at internal and external sites.

Responsibilities And Job Duties

  • Develops and implements approved corrective action plans at cGMP manufacturing facilities.
  • Performs detailed data analyses and root cause analyses to identify solutions to complex problems.
  • Leads continuous process monitoring efforts and applies statistical tools to identify and improve productivity, efficiency, and robustness in manufacturing.
  • Actively engages in the identification, sharing, facilitating implementation, and adaptation of best practices cross-functionally and between manufacturing sites.
  • Implements change controls, leads selection and implementation of new equipment and materials at manufacturing facilities to improve existing and new processes.
  • Drives technology transfer activities to internal and external manufacturing sites and corporate partners and serves as the technical expert in supporting manufacturing at CMOs. Performs fit-to-plant projections and plan for new processes and implements processes in multiple manufacturing facilities.
  • Guides technical development early in the product lifecycle to ensure facility/operational considerations are factored into process decisions. Minimum Qualifications
    • Bachelor's degree in Biology, Chemistry, Biochemistry or related life sciences or engineering field and 8 years relevant experience OR
    • Master's degree in Biology, Chemistry, Biochemistry or related life sciences or engineering field and a minimum of 5 years relevant experience
    • Direct hands-on experience with commercial scale biopharmaceutical manufacturing support for mammalian cell culture and/or purification processes
    • Must have upstream experience.
    • Experience authoring and reviewing technical reports.
    • Experience with Deviation, CAPA and Change Control systems

      Knowledge, Skills And Abilities
      • Ability to critically analyze data using statistical tools for process performance to compile technical reports and other documentation.
      • Work with cross functional teams resulting in creative and positive outcomes.
      • Strong verbal, presentation and writing skills to communicate effectively internally and externally.
      • Solid understanding of overall manufacturing process, and strong technical knowledge of either upstream unit operations.
      • Knowledge of current cGMP and US regulation.
      • Excellent organizational skills, ability to prioritize multiple projects, and attention to detail.
      • Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.
      • Solid proficiency in the use of Microsoft software (Word, Excel, PowerPoint)
      • Ability to travel up to 10% if needed. No sponsorships or third party for this position.
        Will relocate for senior person.

        For immediate consideration, email a word version of your resume to and mention #15343

Keywords: Scientific Search, Rockville , Senior Manufacturing Sciences Technology Associate, IT / Software / Systems , Rockville, Maryland

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