Senior Scientist, Drug Product Development

JOB PURPOSE

We are seeking a talented and experienced individual to join Sana Early Stage Process Development team as a Drug Product and formulation development lead. This role will be responsible for formulation development and preclinical production of sterile injectable 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

• Lead early stage Drug Product development of novel tissue-specific lentiviral vectors (LVV) for in vivo administration
• Work with Therapeutic areas and Pharmacology/Toxicology teams to define the in vivo LVV dosage forms
• Optimize liquid and frozen formulations of LVV Drug Substance and Drug Product
• 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 and expiry of Drug Substance and Drug Product
• 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
• Perform housekeeping duties in the lab, including equipment maintenance and ordering supplies

QUALIFICATIONS

Basic Qualifications

• PhD. in pharmaceutical sciences, organic/physical/analytical chemistry, or chemical/biochemical engineering with up to 5 years of experience in academic research or industry or BA/MS with 8+ years of experience
• Expertise in a wide range of biochemical and biophysical characterization tools for small molecules and biologics
• Strong knowledge of biophysical characterization methods of visible and sub-visible particles
• Experience in sterile drug product development
• Familiarity with formulation development of viruses or lipid nanoparticles
• 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 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.

PHYSICAL REQUIREMENTS

The job will require to occasionally lift up to 50 lbs.

DIRECT REPORTS

This position offers an opportunity to have direct reports as the organization grows.