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Director, Analytical Development

4 months ago

Cambridge, United States Flagship Ventures Full time

The Company:

FL85 is a Flagship-backed, privately held biotechnology company on a mission to transform the current approach to information molecule therapeutics to unlock their full therapeutic potential. In recent years, we have begun to experience the power of information molecules in treating historically undruggable diseases and in designing therapies with unprecedented turnaround times. FL85's platform integrates nanoparticle development with world-class informatics technologies and a novel pipeline of experimentation and discovery to drive a new generation of highly effective, therapeutically relevant information molecule therapies. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us

"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."

Position Summary:

FL85 is seeking a Director of Analytical Development to join our team to lead development of assays focused on CMC development of products based on FL85's novel technology platform. Methods initially will enable build-out of early research and the FL85 platform, and expand to support product characterization and GMP/QC release /stability. The role requires experience developing methods for RNA/nucleic acids and lipid nanoparticle (LNP) therapeutics. The individual will contribute to defining the analytical control strategy and support regulatory filings. Joining the Technical Development Group (CMC), the individual and their team will be part of a collaborative effort where communication and partnership are critical.

Responsibilities: Technical lead of analytical method development for nucleic acids, lipids, & lipid nanoparticles as part of development of FL85 platform, product, process, and formulations Develop methods that are fit-for-purpose to support the requirements of both early-stage development and progression into the clinic/GMP and manage their evolution Use platform approaches & new technologies to effectively enhance the pipeline Develop high-throughput analytical methods in partnership with the automation team Contribute to analytical control strategy for drug substance/product and critical materials. Serve as analytical lead on product development and/or platform teams Provide input on the design of comparability and stability studies and support execution Author/review method transfer, validation, data analysis & reporting for GMP & regulatory submissions Effectively collaborate with fully integrated CMC and development teams Manage and help grow a scientific team and demonstrate organizational leadership Qualifications:

M.S./PhD or equivalent in a relevant biological discipline and at least 10 years of relevant pharmaceutical industry experience Experience with mRNA, lipid nanoparticles, biologics, gene therapy Deep knowledge of relevant analytical methods incl. biochemical, biophysical, bioanalytical, and cell-based. E.g. Fragment Analyzer, CE, LC/MS, PCR (qPCR, ddPCR), ELISA, SDS-PAGE, DLS, and cell-based assays Knowledge of GMP requirements Experience writing validation protocols / reports, relevant sections of regulatory documents Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team Demonstrated ability to work in a fast-paced environment Excellent troubleshooting and problem-solving

A background in nucleic acid chemistry / biology and knowledge of the molecular components involved with mRNA production and lipid nanoparticles will be highly valued. Candidates with experience and training in analytical chemistry, biochemistry, oligonucleotides, nucleic acid/mRNA modality development and characterization and high-throughput techniques will be preferred. The candidate must be independent, goal-oriented, and able to effectively lead teams across several efforts. The position will require creativity, resourcefulness, and adaptability. We are searching for enthusiastic, innovative, and highly motivated individuals who are comfortable working in a fast-paced entrepreneurial environment.

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. #J-18808-Ljbffr