Principal Scientist/Associate Director, Analytical CMC (Biologics)
Entrada Therapeutics is a biotechnology company dedicated to transforming the treatment of devastating diseases through the intracellular delivery of biologics. Entrada’s technology enables the efficient intracellular delivery of proteins, peptides and nucleic acids, thus allowing for the development of programs across several intracellular target classes. The Company’s novel approach addresses current challenges associated with both large and small molecule therapeutics and represents a fundamental advancement in the delivery of molecules into the cell.
Entrada is comprised of experts and leaders in both biologics development and the rare disease space. In December 2018, Entrada closed a $59 million Series A from 5AM Ventures, MPM Capital, Roche Venture Fund, MRL Ventures Fund and Agent Capital.
Entrada is seeking a highly motivated, collaborative and innovative Principal Scientist, specializing in the analytical method development and characterization of protein therapeutics to join the Company’s CMC team. The candidate will work with a world-class, multidisciplinary team of scientists in developing and performing a range of protein characterization methods. The candidate will also contribute to scientific publications and regulatory submissions to support development programs as required.
The Principal Scientist will be responsible for leading analytical team within the CMC group. The successful candidate will act as the Analytical team lead and assure all CMC and discovery analytical deliverables are met for multiple projects, from clone selection and through IND/BLA filings. The Analytical team lead is expected to possess deep scientific knowledge of multiple modalities including antibodies, antibody drug conjugates, PEGylated and unPEGylated recombinant proteins. The Analytical team lead will define and drive the overall analytical strategy for various discovery and development programs, which includes identifying critical quality attributes and setting a phase appropriate control strategy. The team leader is responsible for project planning and assuring both timeliness and high quality of deliverables.
- Lead development of overall analytical strategy and manage delivery and timeline of analytical development activities. This includes method development, release testing, comparability, structural and functional characterization, stability studies, regulatory filings and related activities
- Support drug substance and drug product process development including characterization of starting materials, intermediates, final API and finished product
- Develop, optimize and validate analytical methods
- Manage selection, method development, assay transfer, qualification and work carried out by contract research or manufacture organizations
- Support drug substance and drug product impurity characterization and identification
- Interpret and present research data and findings in internal meetings
- Contribute effectively to patents, reports and publications of scientific findings
- PhD/MS in protein chemistry, analytical chemistry, biochemistry or a relevant scientific discipline and a minimum of 6+/9+ years’ experience in CMC development of early and late-stage biologics
- Strong program management and project management skills and adept at working collaboratively with cross functional teams
- Strong interpersonal and communication skills and knowledge of analytical and biochemical techniques, chromatography, biological function and biologics characterization
- Experience in oversight of CROs/CMOs for biologics method development, characterization, technology transfer and release
- Knowledge of biologics CMC development from preclinical through clinical to commercialization
- Ability to multi-task while remaining organized to meet research and development goals
- Ability to collaborate with interdisciplinary team with excellent written and oral communication skills
- Drive to solve problems and ability to work independently
Entrada Therapeutics’ mission is to treat devastating diseases through the intracellular delivery of biologics.
Compensation is competitive and commensurate with experience. Competitive health, dental and vision coverage. Life insurance and short-term and long-term disability insurance provided. Covered monthly subway pass, subsidized parking or subsidized monthly commuter rail pass.