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:

• BS and 10+ years of experience, or MS and 8-11 years of experience, or PhD w/ 2-7 years of experience. A degree in Chemical Engineering, Bioengineering, Biological Sciences, or related field. Experience must include working in an industry setting.
• 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:

• Technical understanding of nucleic acid chemistry, plasmid processing and standard analytical techniques for macromolecules.
• Hands on experience with in vitro transcription, mRNA purification technologies in biopharmaceutical process purification.
• Previous supervisory experience.
• Experience and success working in cross functional teams, including CMC.
• Experience as process lead and SME for downstream process development.
• Ability to apply Design of Experiments (DoE), process characterization (phase appropriate).
• Experience with scale-up and technology transfer for GMP manufacturing.
• Experience with laboratory automation (Tecan Fluent) for high throughput purification development.
• Experience preparing regulatory filings for IND/IMPD applications.

More About Flagship Pioneering

Flagship Pioneering has conceived of and created companies such as Moderna Therapeutics (NASDAQ: MRNA), Editas Medicine (NASDAQ: EDIT), Omega Therapeutics (NASDAQ: OMGA), Seres Therapeutics (NASDAQ: MCRB), and Indigo Agriculture. Since its launch in 2000, Flagship has applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures. In 2021, Flagship Pioneering was ranked 12th globally on Fortune's "Change the World" list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies.

Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.