Position Summary
- 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.
- 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.
Responsibilities:
As a member of Process Development, the primary goal of the position is to:
- 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.
Qualifications:
Education (Min):
- 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.
Required Experience and Skills:
- 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 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.