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Latitude, Inc. Bioprocess Engineer in Gaithersburg, Maryland

Job Type: Full-time

Salary: $100,000.00 to $140,000.00 /year

The Bioprocess Engineer will be a key member of the Manufacturing Sciences team, working collaboratively to ensure successful manufacturing process technical transfers, campaign execution, product release, and regulatory submission. Additionally, he/she will support the establishment of the new manufacturing facility from detailed design through equipment selection and/or commissioning/qualification.

We are seeking several Bioprocess Engineers at multiple levels of experience.

PRIMARY RESPONSIBILITIES

Technology Transfer/Manufacturing Campaign Oversight

  • Support technology transfer for products from REGENXBIO to external Contract Manufacturing Organizations in partnership with Process Development and Analytical Development.

  • Support development of and maintenance of technology transfer deliverables (PFD, BOM, Sample Plans, etc) as needed.

  • Serve as manufacturing reviewer of CMO documentation (batch records, sample plans, etc).

  • Provide technical support to CMO organizations as required to support successful completion of drug substance 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 Process Information management Systems (Skyland PIMS as an example) as a manufacturing data repository and ensure 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.

  • Provide technical review of product-related regulatory submissions, and author CMC content as appropriate. Provide technical support of product-specific technical questions and on-site participation for significant inspections (e.g. PAI)

Manufacturing Facility Design and start up

  • Support the detailed design of the RGX Manufacturing Facility by providing technical input into the facility design and equipment selection.

  • Support/lead development of facility and equipment URS documentation as appropriate.

  • Support facility/equipment commissioning and qualification as appropriate.

  • Provide technical input on process scale up for commercial manufacturing.

SKILLS, KNOWLEDGE AND ABILITIES REQUIRED

  • BS/BA degree in either biological or chemical science or engineering or equivalent technical discipline.

  • Minimum of 5-8 years industry experience (depending on degree) in process development, manufacturing sciences/tech transfer, or GMP operations for biologics, pharmaceutical or vaccine products.

  • Familiarity with manufacturing of biologics, including unit operations, GMP requirements, and regulatory requirements.

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