Crown Bioscience

Manufacturing Sciences Engineer II

Crown Bioscience • $80K — $110K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
2 weeks ago
Job Overview by Ladders

Qualifications

  • BS in Science or Engineering with 4+ years industry experience, or Master's with 2+ years industry experience, or PhD with no experience.
  • Expertise in upstream and/or downstream processing in biologics.
  • Experience with technical transfer and scale-up processes.
  • Familiarity with GMP compliance requirements.
  • Working knowledge of Process Development and IND development.
  • Proficiency in English with exceptional communication skills.
  • Strong engineering and scientific reasoning abilities.

Responsibilities

  • Lead technical transfer projects for platform and repeat clinical manufacturing programs.
  • Support and drive business decisions related to facility fit and new technologies.
  • Perform facility fit activities including generating process flow diagrams and BOMs.
  • Provide technical support for cGMP production runs and handle deviations and CAPAs.
  • Deliver supervisory support during technical document execution and equipment testing.
  • Compile and analyze process data, communicating updates to clients and management.
  • Lead investigational efforts to troubleshoot and recommend manufacturing improvements.

Benefits

  • Health, dental, and vision insurance.
  • 401(k) with company matching.
  • Paid time off and holidays.
  • Professional development and continuing education opportunities.
  • Flexible work schedule options.
Full Job Description
JOB SUMMARY The Upstream MS&T Engineer II will apply sound scientific and engineering principles to successfully transfer and enroll new biopharmaceutical processes into the cGMP manufacturing facility. The scope of this role includes:

  • Leading technical transfer projects for platform and/or repeat clinical manufacturing programs
  • Supporting and/or driving business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client
  • Performing facility fit activities including process flow diagram generation, scaleup calculations, defining equipment and solution requirements, and generation of bill of materials (BOM) and new item specifications
  • Providing technical support for cGMP production runs, CAPAs, process and product impact assessments for deviations and change controls
  • Providing supervisory and technical support for cGMP production runs, deviations and process/product impact assessments, change controls, and CAPAs
  • Providing supervisory and technical support during technical document execution, new equipment testing, water runs in manufacturing.
  • Compiling/Collecting and analyzing process data and communicating out to the client and upper management via production updates and campaign summary reports
  • Supporting/leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation
  • Supporting/leading collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports


JOB RESPONSIBILITIES The candidate should be able to apply engineering principles in-order to problem solve and drive projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to work independently and with teams. The candidate should also possess excellent communication skills.

MINIMUM REQUIREMENTS
  • BS in Science or Engineering with minimum of 4 years industry experience, Master's with 2 years industry experience or PhD with no years industry experience.
  • Expertise in upstream and/or downstream processing techniques and equipment in biologics
  • Experience with technical transfer and scale up is required
  • Experience with GMP compliance requirements
  • Working knowledge of Process Development and technical knowledge supporting IND development and early phase GMP production • Experience working in a cGMP manufacturing environment is preferred
  • Strong proficiency in English and overall communication is required
  • Strong engineering and scientific reasoning skills are required
  • Strong math skills are required
  • Position requires limited physical demands
  • Strong computers skills are required particularly in all MS Office programs
  • Some equipment operations and testing is required


About Crown Bioscience

Crown Bioscience is a global drug discovery and development services company that specializes in preclinical research. The company was founded in 2006 and is headquartered in Shanghai, China. Crown Bioscience provides a range of services to pharmaceutical and biotechnology companies, including in vitro and in vivo testing, translational oncology, and more. The company has facilities in China, the United States, and Europe. Crown Bioscience is committed to advancing drug discovery and development through innovative research and technology.
Learn more about Crown Bioscience
Size
1,000 employees
Industry
Pharmaceuticals & Biotech
Founded
2006
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Crown Bioscience

More Pharmaceuticals & Biotech Jobs

Find similar Manufacturing Sciences Engineer II jobs:

NationwideDurham, NC