- Master's Degree
- Doctoral Degree
- Bachelor's Degree
- Communication Skills
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 REGENXBIO manufacturing facility from detailed design through equipment selection and/or commissioning/qualification.
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.
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.
Familiarity with manufacturing of biologics, including unit operations, GMP requirements, and regulatory requirements.
Expertise in either cell culture or purification unit operations and equipment with practical experience transferring or receiving manufacturing processes.
Experience in authoring technical documents, reports, protocols, and regulatory submissions including (INDs, BLAs, and equivalent).
MS or Ph.D. preferred.
WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS
Lifting to 30 lbs
Travel up to 25%
Individuals may be required to work in a biosafety level 2 lab
The working condition will be in climate-controlled room temperature between 15-30 C
There will be some exposures to chemicals and biologics but under proper protection and ventilations