Postdoctoral Research Fellow; Drug Product Technical Services

Postdoctoral Research Fellow (Drug Product Technical Services)

Lexington, MA, United States

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology.

Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a clinical program in obesity and a preclinical program in NASH/MASH. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description:

Wave Life Sciences is hiring a Postdoctoral Research Fellow reporting to the Senior Director within the Drug Product Technical Services team in Lexington, MA. This role involves working on developing oligonucleotide drug products for multiple clinical programs and provides exposure to the entire drug development lifecycle in a cross functional team environment within the CMC group. This position offers an opportunity to contribute to the development of novel RNA therapies and gain industry experience in an innovative company.

Responsibilities:

• Design and execute formulation development studies to optimize oligonucleotide DP formulations
• Conduct pre-formulation studies to assess physicochemical properties of various excipients and identify potential issues
• Investigate the stability of formulations under different conditions and apply biophysical and analytical techniques to characterize molecular interactions and their impact on stability
• Develop and implement analytical methods for characterizing oligonucleotide drug products using techniques such as pH meter, Osmometer, Densitometer, HPLC/UPLC, UV spectrophotometry/ Solo VPE, lyophilizer, DSC (Hands on experience on these instruments preferred)
• Evaluate and implement new technologies for formulation improvement ensuring compliance with clinical and regulatory requirements
• Collaborate with cross-functional teams within CMC to achieve project goals and assist with technology transfer activities at CMO
• Present research findings at internal meetings and conferences
• Maintain detailed records of experiments in Lab notebooks
• Complete training and certifications on GLP practices and possess excellent literature review skills while sharing expertise with the team
• Author and review technology transfer documentation including process descriptions, risk assessments, comparability protocols, and batch records
• Participate in process scale-up, troubleshooting and root cause investigations during tech transfer campaigns

Preferred Qualifications:

• Ph.D. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related field
• Strong background in drug product and formulation development, preferably with experience in oligonucleotide therapeutics
• Proficiency in various analytical techniques used in formulation development
• Experience with different formulation development strategies for parenteral delivery
• Excellent problem-solving and data analysis skills
• Strong communication skills for presenting scientific data
• Ability to work independently and collaboratively in a team environment
• Demonstrated scientific curiosity and a passion for advancing RNA medicines
• Knowledge of applicable regulatory and quality standards (ICH, FDA, EMA) is desired

Duration: This is a 2-year Postdoctoral Research Fellow position.

Pay Range External Disclosure Statement

The annual base salary range for this position is $81,000 - $110,000.

The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on…