What are the responsibilities and job description for the Associate Director / Principal Scientist Analytical Development, (LNP / Biophysical) position at Flagship Pioneering, Inc.?
Company Summary:
Laronde is pioneering a platform that offers a completely novel way of modulating human biology via Endless RNA™ (eRNA). eRNA is a uniquely engineered RNA that can be programmed to express diverse proteins inside the body. Laronde is rapidly scaling to support the development of multiple programs across many disease areas.
Laronde was founded in 2017 by Flagship Labs, the innovation foundry of Flagship Pioneering. Laronde has a highly collaborative, dedicated culture, driven to achieve our vision of “making eRNA an essential class of medicines to everyone, everywhere”. To learn more, please visit the company’s website at https://www.laronde.bio.
Position Summary:
Laronde is seeking a creative, motivated Associate Director/Principal Scientist to join the Analytical Development team. We are searching for a driven, enthusiastic, and self-motivated individual who is comfortable multitasking, collaborating, and working independently. The successful applicant is expected to manage a team and to provide leadership for development of bioassays, immunoassays, and molecular biology-based methods for GxP and characterization purposes for our eRNA platform and to work cross-functionally to advance the Laronde pipeline.
Key Responsibilities:
- Provide strategic leadership and technical expertise for development of assays designed to assess potency and impurities for GMP and characterization purposes
- Develop and implement methods intended for a variety of purposes, including release and stability testing, product characterization, and high throughput analysis
- Oversee troubleshooting, tech transfer, and phase-appropriate method validation at contract testing labs
- Work across the AD team and cross-functionally to lead, plan, and execute complex characterization studies; serve as the analytical lead in cross-functional interactions
- Review, interpret, and present data within the analytical team and cross-functionally
- Author and review method validation documents, technical reports, and regulatory submissions
- Train and mentor junior team members
Required Qualifications:
- PhD in biology, biochemistry, chemistry, or related field with a minimum of 12 years of experience, or BS/MS with additional experience in a relevant biotech/pharma setting
- Expertise in a variety of cell- and molecular-based methodologies; experience with developing potency assays according to regulatory guidance
- Experience with:
- Dynamic light scattering (DLS)
- Liquid chromatography
- Lipid nanoparticles (LNPs) engineering, formation and nucleic acid or protein encapsulation
- Strong understanding of regulatory guidelines and requirements for early-phase development candidates; familiarity with GMP processes and practices
- Proficiency in good documentation practices and data analysis and reporting
- Demonstrated ability to achieve in a fast-paced and entrepreneurial environment
Preferred Qualifications:
- Prior people management experience
- Experience with the following
- Liposome purification-size-exclusion (ÄKTA system)
- Purification and characterization of RNA
- mass spectrometry (LC-MS)
Laronde is 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: Laronde does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Laronde or its employees is strictly prohibited unless contacted directly by Laronde’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Laronde, and Laronde will not owe any referral or other fees with respect thereto