Principal Scientist, Process Engineering

Responsibilities

• Conduct laboratory experimentation and analytical testing of putative formulations & drug product manufacturing
• Follow administration/delivery approaches for select protein therapeutic assets, including contributing to, the conception & evaluation of conventional & novel product matrices and administration modalities
• Partner closely with the manufacturing groups during process development and technology transfers
• Actively participate with combination drug product assessment and collaborate with device engineering
• Physicochemical and bioanalytical characterization of native and modified biopharma compounds
• Collaborate with the Bioanalytical Sciences group to develop & transfer stability-indicating analytical methods for use in product development
• Oversee release & stability testing; crafting & execution of non-GMP stability protocols to test quality & stability of product formulations
• Engage with the Analytical Technology Transfer and Stability group to craft GMP stability protocols
• Audit resultant data; working closely with internal & external discovery and development support partners as needed
• Maintain accurate, complete laboratory records and ease use of electronic data & information gathering, capture, archiving and communications techniques.
• Aid in preparation and review of manufacturing batch records, SOPs, and regulatory documentation as appropriate.

Job Requirements and Qualifications

• Basic Qualification: (Required Education & Experience)
  • PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
  • 1-3 years of protein formulation and drug delivery development experience
  • OR Master’s degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
  • 5-7 years of similar experience in protein formulation and drug delivery development experience
  • OR Bachelor’s degree Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
  • 10 or more years of similar experience in protein formulation and drug delivery development experience
• Preferred Experience: (candidates who meet BQs & these qualifications (PQs) especially qualify to be shortlisted for candidate submission)
  • Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development, including the application of DOE and other statistically based experimental design/interpretation approaches.
  • Experience with protein product manufacturing processes and development (e.g., solution (vial/PFS), or lyophilization; container/closure assessment & selection), drug delivery (e.g., combination product, device & administration kit) feasibility and compatibility evaluation.
  • Experience and understanding of multiple bioanalytical and biophysical assessment techniques for product characterization and product stability evaluation, including HPLC, SDS-PAGE/CGE, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), DSC, particles evaluation by HIAC and/or orthogonal techniques (eg MFI, FlowCam, Archimedes), capillary electrophoresis & chip-based methods, etc.
  • Experience in authoring, contributing to, and critical review of successful regulatory submissions; with particular emphasis on late clinical phase submissions, BLA/MAA filings, response to regulatory questions, and pre-approval inspection experience.
  • Experience in working with in vivo/ in vitro models to critically assess formulation & delivery modalities
  • Experience in drug product manufacturing technology transfer to commercial and/or scale-up of clinical drug product manufacturing capabilities would be beneficial.

Physical Demands

• Must be able to remain in a stationary position more than 25% of the time
• The person in this position needs to occasionally move inside and outside labs
• Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
• Regularly move or lift up to 25 pounds and occasionally move or lift up to 100 pounds
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer

Working Environment

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment.
• Job pace may be fast and job completion demands may be high.
• Employee may be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling.
• Ensure safety, security, and the environment in all aspect of the daily activities, and any potential safety hazards are addressed and corrected immediately.
• Understand ergonomic relationship between people, equipment and working environment.