Latitude, Inc. Bioprocess Engineer in Gaithersburg, Maryland
Job Type: Full-time
Pay: $100,000.00 - $140,000.00 per year
As the Bioprocess Engineer, you will be a key member of the Manufacturing Sciences team, working collaboratively to ensure successful manufacturing process technology transfers, campaign execution, product release, and regulatory submission. Additionally, you will support the establishment of our new manufacturing facility.
What you?ll be doing
Technology Transfer/Manufacturing Campaign Oversight
Support technology transfer for products into Manufacturing (at Contract Manufacturing Organizations or at REGENXBIO) in partnership with Process Development and Analytical Development.
Lead project teams as required in support of technology transfer.
Author and maintain of technology transfer deliverables (PFD, BOM, Sample Plans, etc) as needed.
Serve as lead technical reviewer of manufacturing documentation (e.g. batch records).
Provide technical support as required to support successful completion manufacturing campaigns. Provide person in plant support as required.
Author process change controls, technical support memos, and campaign summary reports as relevant to support manufacturing campaigns.
Support the use of a process information management system and ensure that manufacturing data is appropriately captured from each manufacturing campaign.
Support process risk assessments, including mitigation plans. Establish and maintain product knowledge expertise, ensuring critical processing knowledge is translated effectively to operational personnel and others as required.
CMC Program Support
Serve as MFG representative and provide support to CMC teams as required. Support the development/maintenance of manufacturing schedules/dashboards/tools as required.
Author and review CMC content in product related regulatory submissions as appropriate. Provide technical support of product-specific technical questions and on-site participation for significant inspections (e.g. PAI)
Manufacturing Facility start up
Support facility/equipment commissioning and qualification as appropriate.
Partner with Manufacturing, Engineering, Qality, and Process Development to ensure theon time manufacturing facility start up.
Minimum of BS/BA degree in either biological or chemical science or engineering or equivalent technical discipline.
Industry experience in process development, manufacturing sciences/tech transfer, or GMP operations for biologics, pharmaceutical or vaccine products required (2 years MS/PhD, 5 years BS)
Demonstrated scientific creativity, technical proficiency and knowledge of scientific concepts
Strong oral and written communication skills with demonstrated ability to perform well on cross-functional teams