Scientist II/Senior Scientist, mRNA Purification Process Development

Company Summary:

Tessera Therapeutics is pioneering Gene Writing™— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

 

Position Summary:

The Scientist/Senior Scientist will be responsible for leading the development of in-house mRNA purification processes for pre-clinical and clinical manufacturing. We are searching for an experienced, driven, enthusiastic and self-motivated individual with a proven track record of successfully developing scalable purification processes for early and late-stage clinical programs. The ideal candidate will have technical expertise in typical downstream unit operations including chromatography, tangential-flow filtration and filtration with additional experience in process scale-up, technical transfer and GMP manufacturing.  The Scientist/Sr Scientist will be able to design and execute experimental studies and critically interpret results and generate appropriate conclusions. The individual will author sections of regulatory submissions and design and execute process characterization studies to support programs at various clinical stages. Hands on experience in high throughput automation with the Tecan Fluent for purification process development is a plus. The Scientist/Sr Scientist will interface in cross-functional teams, participate in CMC project teams, and will have previous experience as a technical/team lead providing technical leadership to direct and matrix reports within Purification Process Development.  This individual will join a dynamic team and will help to foster a culture of collaboration, scientific innovation, and excellence.  

Key Responsibilities:

• Program lead for process development, scale-up and tech transfer activities within the Purification Process Development Group ensuring the development of robust processes that successfully meet regulatory requirements.
• Lead and perform hands-on work in mRNA purification process development group working with instrumentation such as the AKTA Avant and TFF.
• Function as a SME for downstream process development and CMC – providing technical guidance to mentor group members in key aspects of downstream purification and scale-up.
• Screening, optimization, and scale-up efforts for RNA purification using Design of experiments (DoE) principles via chromatographic separations and filtration processes including TFF and dead-end filtration.
• Author sections for regulatory filings and technical reports. Prepare and present experimental findings and program updates for department and cross-functional team meetings.
• Write protocols and technical reports to support drug substance and drug product clinical development.
• Supervise staff in direct and/or matrixed reporting capacity – providing guidance, feedback, and mentoring.
• Provide high quality results and documentation in electronic lab notebooks.
• Collaborate effectively with formulation and analytical development teams.

 

Basic Qualifications:

• PhD w/ 2+ years or MS with 6+ years of relevant industrial experience. A degree in either Chemical Engineering, Bioengineering, or Biological Sciences. The hiring level will be commensurate with combination of education and relevant experience.
• Ability to apply Design of Experiments (DoE) to resolve complex scientific problems, along with prior experience in process characterization (phase appropriate) to support IND/IMPD applications.
• Prior experience with scale-up and technology transfer of downstream purification process for Tox and GMP manufacturing.
• Proven track record of successfully developing scalable downstream purification processes that meet regulatory acceptance criteria along w/ experience drafting and writing sections for regulatory filings.
• Managing process development programs to deliver robust, scalable processes that meet program timelines.
• Eager to work with highly skilled and dynamic teams in a fast-paced, entrepreneurial, and technical setting.
• The successful candidate should be collaborative, communicative, and passionate about working with RNA molecules leading to mediate the next generation of genetic medicines.

 

Preferred Qualifications: