Sr Staff Manufacturing Sciences and Technology Specialist

Summary: Provides key technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and may provide oversight and leadership in the transfer of manufacturing processes for new therapeutic areas and methods.

Essential Duties and Responsibilities:
Provide leadership in new therapeutic areas to assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities; generates facility fit assessments and high-level gap assessments.
Coordinates the creation, management and maintenance of detailed gap assessments during the lifecycle of a transfer.
Accountable for generating and reviewing documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments, as appropriate).
Leads projects and initiatives associated with developing new technical support tools for technology transfers.
Collaborates with managers to continuously assess and adjust technical support activities and functions.
Performs complex, in-depth reviews of technical document content, including FMEAs, PAR reports, regulatory submissions, etc.
Leads study teams and investigations during transfers, as applicable (internal and external).
Monitors and prioritizes processes and troubleshoots technical difficulties as needed.
Generates options to resolve technical challenges and present them for endorsement.
Gathers, trends and analyzes process generated data; summarizes findings in memos and reports and presentations.
Performs review of manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.).
Works effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
Ensures all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
Helps to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database; identifies continuous improvement activities to improve performance.
Assists in developing strategic long term vision for technical support activities impacting tech transfer projects
Informs managers and stakeholders regarding technical document progress, investigations, challenges, metrics, etc.
Up to 10-15% travel may be required in support of tech transfer activities.
Serves as a mentor for lower level specialists.
May involve supervision of lower level specialists.
Other duties as necessary.

Education and Experience:
BS/BA in an engineering or scientific discipline and 12 years of experience or equivalent combination of education and experience.
Biopharmaceutical process development, manufacturing or process engineering experience a plus.

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