Process Development Engineer II

Job Title: Process Development Engineer II
Location: Elkton, VA 22827
Duration: 12 Months+

Work Schedule: Standard Shift

Job Summary:
This position will report to the Technical Operations Department and will support the manufacture of HPV Gardasil as part of a multidisciplinary team, the candidate will have a fundamental knowledge of fermentation and cell culture, protein chemistry and purification, analytical techniques, and/or laboratory operations.
Join our Process Development Team in using a variety of fermentation techniques, purification techniques, and characterization methods to support commercial and bench scale pharmaceutical processes. The PD team uses a scale down model to provide investigation support, promote process understanding, and facilitate technology transfer of products to the Elkton site. We work with teams across the network to bridge process, quality, and analytical principles and synthesize these into a focused laboratory that provides high quality support to realize the sustained production of medication for patients.
 
Job Responsibilities:
• Characterize proteins, VLPs and constituent components with a variety of analytical techniques.
• Participate in/drive fermentation and/or purification of proteins/VLPs at lab and pilot scale.
• Provide support for execution of process development activities and manufacturing investigations.
• Perform laboratory scale studies.
• Design and troubleshoot experiments.
• Employ excellent verbal and written communication skills.
• Author laboratory notebooks and technical documents.
• Work both independently and within multidisciplinary team.
• Produce high quality work Product firm deadlines.
• Maintain good sample handling practices.
• Balance and prioritize competing deliverables.
• Commit to creating a diverse and inclusive workplace.
 
Qualification/ Requirements:
A bachelor’s (w/4+ yrs. purification experience) or masters (2+ yrs purification experience) or Ph.D. degree (direct experience) in a relevant scientific discipline (biochemistry, chemistry, biology), life sciences, Engineering
• Experience with protein purification from bacterial or yeast or mammalian systems in a laboratory or pilot or commercial scale.
• Hands on experience using AKTA Purification Systems
• Strong background in protein biochemistry
• Experience with biochemical and analytical methods for protein and or DNA analysis.
• Wet chemistry laboratory skills (pipetting, buffer preparation, filtration, dilution, stoichiometry)
• Proficiency with technical writing and laboratory records (laboratory notebooks, chemical inventory, data management)
• Excellent collaborative and team-working skills
• Strong technical problem-solving abilities, data interpretation and presentation competence


Preferred Experience and Skills:
• Experience working with protein purification
• Experience working with column chromatography and AKTA/Unicorn systems
• Experience working with tangential flow filtration processing – microfiltration/ultrafiltration
• Experience performing fermentation or cell culture studies at the labs scale
• Experience performing fermentation or cell culture studies using shake flasks
• Knowledge of yeast fermentation and metabolism
• Experience working in GMP and GLP environments
• Experience with laboratory operations
• Experience with facility operations
• Experience working in an industry environment
• Experience conducting laboratory scale process characterization studies
• Experience troubleshooting technical issues (experimental, equipment-related issues)
• Experience with material characterization
• Experience working with enzymes and pepProducts
• Experience in method development and method transfer
• Experience with six sigma, 5S principles