Scientist, Drug Product Development

Location
South San Francisco, CA, United States
Posted
Apr 22, 2021
Ref
5220252002
Required Education
Bachelors Degree
Position Type
Full time
JOB PURPOSE

We are seeking a talented and experienced individual to join Sana Pharmaceutical Development team as a Drug Product and formulation development scientist. This role will be responsible for formulation development of gene therapy drug product. It is a unique opportunity to establish a manufacturing platform for a novel biopharmaceutical modality and to advance lead candidates into clinical trials.

DUTIES AND RESPONSIBILITIES
  • Responsible for lyophilized platform formulation development of novel tissue-specific lentiviral vectors (LVV)
  • Work with Therapeutic areas and Pharmacology/Toxicology teams to define the in vivo LVV dosage forms
  • In collaboration with the Analytical Development team, design and execute IND-enabling stability studies
  • Characterize changes in biological activity and biophysical profile of LVV during processing and storage
  • Develop and perform routine stability-indicating biophysical assays
  • Establish in-process hold times to support drug substance and drug product manufacturing
  • Working with the Drug Substance Development team, define key parameters of the Downstream process impacting LVV biophysical profile
  • Select container closure systems and establish compatibility with LVV
  • Develop the process for drug product compounding, sterile filtration, aseptic filling, freezing and thawing, and dose preparation protocols
  • Produce LVV Drug Product batches to supply in vivo Proof-of-Concept and IND-enabling toxicology studies
  • Working with CMC teams, participate in a CMO site assessment and perform technology transfer of the Drug Product process.
  • Responsible for authoring documentation, such as batch records, sampling plans, stability study designs, development reports, and CMC regulatory submissions
  • Trend stability data, perform statistical analysis and present results to teams
  • Maintain thorough electronic notebook records
  • Support development programs including cell therapy.
  • Perform housekeeping duties in the lab, including equipment maintenance and ordering supplies

QUALIFICATIONS

Basic Qualifications
  • PhD in scientific discipline and up to 2+ years academic or industry experience. BA and/or MS plus 7+ years or equivalent combination of education and work experience; Strong knowledge of required principals and concepts with understanding of context for application.
  • Expertise in lyophilized formulation development of biologics, viruses or lipid nanoparticles
  • Familiarity with a wide range of biochemical and biophysical characterization tools for biologics or viral vector
  • Strong knowledge of biophysical characterization methods of visible and sub-visible particles
  • Experience in sterile drug product development
  • Understanding of regulatory guidelines for GLP and GMP Drug product manufacturing
  • Ability and willingness to work in a laboratory setting
  • Hands-on experience with manual and automated sterile fill operations
  • A team player, participating in cross-functional teams and able to lead
  • Excellent communication, documentation, and presentation skills
  • The candidate should be highly organized, demonstrate curiosity and scientific rigor and excellent problem-solving skills.
  • Ability to engage in crucial conversations - providing and receiving feedback
  • Working knowledge of the DoE approach to experimentation and statistical analysis

Preferred Qualifications
  • cGMP cell or gene therapy manufacturing experience
  • Experience in expression and purification of viral vectors
  • Knowledge of biochemical and biophysical methods to characterize viral vectors
  • Skilled in cell-based assays, ELISA, and FACS
  • Experience with cell therapy, cell culture, upstream, and downstream bioprocess development
  • Process modeling, programming, and automation
  • Cross-functional project management and leadership experience
  • Tech transfer and working with CMOs
  • Familiar with FDA and EU regulations and GMP standards

WORKING CONDITIONS

The incumbent should be able to operate safely in a BSL2 class laboratory environment and perform aseptic operations in a biosafety cabinet. Occasional travel may be required up to 10% of the time.