Associate Engineer II

Work Location: Elkton, VA 22827

Position Summary: Support the manufacture of pharmaceutical products as part of a multidisciplinary Process Development Team, focusing on fermentation, purification, and analytical techniques.

Background & Context:

• 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.
  
  Key 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 against firm deadlines
• Maintain good sample handling practices
• Balance and prioritize competing deliverables
• Commit to creating a diverse and inclusive workplace
  
  Qualification & Experience:
• 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
• 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 environments
• Experience conducting laboratory scale process characterization studies
• Experience troubleshooting technical issues (experimental, equipment-related issues)
• Experience with material characterization
• Experience working with enzymes and peptides
• Experience in method development and method transfer
• Experience with six sigma, 5S principles