Senior Scientist, Drug Product Development
- Employer
- Sana Biotechnology
- Location
- Cambridge
- Posted
- Jan 09, 2021
- Ref
- 5025408002
- Discipline
- Marketing, Product Development/Management, Science/R&D, Biotechnology, Pharmacology
- Hotbed
- Genetown, NextGen Bio
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
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
QUALIFICATIONS
Basic Qualifications
Preferred Qualifications
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.
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.