Manager/Senior Manager, BioProcess Engineering, Purification Tech Transfer

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POST DATE 9/8/2016
END DATE 10/23/2016

MedImmune, LLC Gaithersburg, MD

Company
MedImmune, LLC
Job Classification
Full Time
Company Ref #
360705
AJE Ref #
576116169
Location
Gaithersburg, MD
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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Manager/Senior Manager, BioProcess Engineering p /p BioProcess Engineering (BPE) department (within BioPharmaceutical Development) is responsible for scale up and transfer of clinical and commercial processes to manufacturing. Members of the purification technology transfer team work closely with the purification process development groups and manufacturing group to support transfers across all stages of purification process development (from Toxicology lot production through production of lots to support BLA filings). This is a leadership position reporting to the Senior Director of the department. p /p Specific responsibilities for this position include: br Review and approve process descriptions and facility fit assessments for multiple internal and external manufacturing sites. Develop predictive tools to map purification processes into clinical and commercial facilities. Review and approve transfer and manufacturing documentation such as batch records, relevant standard operating procedures, sample plans, protocols and summary reports. Investigate new equipment and purification technologies for feasibility to implement across laboratory, pilot and commercial scale production. p /p Interface with Quality, Engineering, Validation, Manufacturing, and Development to solve production issues and to ensure manufacturing process equipment meets quality standards and is acceptable for use in clinical and/or commercial manufacturing. p /p Apply scientific and engineering principles, theories and concepts to assist scale-up of purification operations such as chromatography, viral filtration and ultrafiltration/diafiltration. br Proposes solutions to a wide range of difficult problems, requiring creative thinking skills. p /p Responsible for managing core group of scientists and engineers focused on technology transfer projects. Actively support career development for direct reports and work with peer groups to resolve issues and provide technical guidance to assist manufacturing personnel. p /p Present at internal departmental and cross-functional meetings. Participate and present at external meetings. Responsible for meeting project goals within time and resource constraints. Able to make decisions based on limited amount of data and comfortable with presenting ideas and data to senior leadership. p /p ~BSP p /p