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Full-Time

Director – Analytical Development

Confirmed live in the last 24 hours

Flagship Pioneering

Flagship Pioneering

501-1,000 employees

Biotechnology firm creating health and sustainability solutions

Venture Capital

Expert

Cambridge, MA, USA

Category
Genomics
Biology Lab & Research
Biology & Biotech
Required Skills
Data Analysis
Requirements
  • M.S./PhD in a relevant biological discipline
  • At least 10 years of relevant pharmaceutical industry experience
  • Experience with mRNA, lipid nanoparticles, biologics, gene therapy
  • Deep knowledge of analytical methods like Fragment Analyzer, CE, LC/MS, PCR, ELISA, SDS-PAGE, DLS, and cell-based assays
  • Knowledge of GMP requirements
  • Experience in writing validation protocols/reports and regulatory documents
  • Excellent communication skills
  • Ability to work effectively in a multidisciplinary team
  • Demonstrated ability to work in a fast-paced environment
  • Background in nucleic acid chemistry/biology
  • Experience in analytical chemistry, biochemistry, oligonucleotides, nucleic acid/mRNA modality development, and high-throughput techniques
Responsibilities
  • Lead analytical method development for nucleic acids, lipids, & lipid nanoparticles
  • Develop fit-for-purpose methods for early-stage development and progression into clinic/GMP
  • Enhance pipeline using platform approaches & new technologies
  • Develop high-throughput analytical methods in partnership with 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 design of comparability and stability studies
  • Author/review method transfer, validation, data analysis & reporting for GMP & regulatory submissions
  • Collaborate with fully integrated CMC and development teams
  • Manage and grow a scientific team
  • Demonstrate organizational leadership

Flagship Pioneering fosters a culture of groundbreaking advancements in biotechnology, emphasizing an ecosystem approach that synergizes human health and sustainability. Their business model not only focuses on creating transformative products but also incubates leading companies like Moderna and Indigo Agriculture, positioning them at the forefront of scientific innovation and industry leadership. This approach offers employees a unique opportunity to be part of a pioneering team that drives real-world impacts across multiple sectors.

Company Stage

N/A

Total Funding

$6.4B

Headquarters

Cambridge, Massachusetts

Founded

2000

Growth & Insights
Headcount

6 month growth

8%

1 year growth

14%

2 year growth

34%