Full-Time

Director – Analytical Development

Flagship Pioneering

Flagship Pioneering

501-1,000 employees

Originates biotech ventures for health and sustainability

Venture Capital

Senior, Expert

Cambridge, MA, USA

Required Skills
Data Analysis
Requirements
  • 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
  • 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
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

Flagship Pioneering stands out as a leader in the biotechnology industry, having originated and nurtured over 100 scientific ventures, including high-profile companies like Moderna and Indigo Agriculture. The company's culture is rooted in developing transformative products for human health and sustainability, as evidenced by their creation of platform companies like Generate Biomedicines and Tessera Therapeutics. Their competitive edge lies in their ability to explore new frontiers in genetics, as demonstrated by their recent unveiling of Quotient Therapeutics, a venture aimed at creating transformative medicines.

Company Stage

N/A

Total Funding

$6.4B

Headquarters

Cambridge, Massachusetts

Founded

2000

Growth & Insights
Headcount

6 month growth

9%

1 year growth

24%

2 year growth

48%