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Scientist I, Analytical Development, Biologics
Company | BioSpace |
Address | Waltham, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet News |
Expires | 2023-06-05 |
Posted at | 1 year ago |
RESILIENCE is seeking a talented Scientist I in Analytical Development for the Biologics Franchise who will:
- Work collaboratively with other leaders throughout the network to advance objectives, priorities, and disruptive technologies
- Operate with the mission to develop and transfer robust therapeutic analytical methods for RESILIENCE Biologics partners and drive development and implementation of innovative internal technology platforms
- Function as a key member of the Analytical Development group in Waltham, MA
- Support method transfer to GMP lab
- Design, develop, optimize, and execute biophysical and analytical chemistry methods to characterize biological materials
- Author and review SOPs, reports and other technical documents and regulatory submissions.
- Support scientific research experiments to advance current understanding of bioprocesses
- Represent Resilience at external events through poster presentations, co-authorship of manuscripts, and other forms of active scientific participation.
- Support upstream and downstream process development
- Serve as analytical project support for internal and external client projects
- Analyze data with available bioinformatic tools, scientifically-sound interpretation and present the data to internal and external stakeholders.
- Extensive experience with experimental design, data analysis, and the organization and presentation of complex scientific data.
- Demonstrated capabilities in efficient and thorough analytical method development: ability to lead or support the development of an assay from initial concept to a qualified/pre-validated state.
- PhD - 0-2 years of relevant experience in industry and/or academic research and development labs.
- Masters 2-5 years of relevant experience in industry and/or academic research and development labs.
- PhD, Master's or Bachelors Degree in analytical chemistry, biochemistry, molecular/cellular biology or related field.
- Demonstrated ability to multi-task and be highly productive in a fluid and fast-paced environment.
- Ability to communicate and operate effectively within cross-functional teams.
- Excellent data analysis and data management skills
- Bachelors 5+ years of relevant experience in industry and/or academic research and development labs.
- A self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP environment.
- Knowledge of and/or interest in laboratory and equipment automation and maintenance.
- Knowledge of the ICH and USP guidelines for assay qualification and validation.
- Hands-on experience in bioassays, biochemical and/or biophysical assay development, qualification/validation, tech transfer and lifecycle management of methods.
- Experience with analytical/statistical software (JMP, Softmax Pro, XLfit, Gen5).
- Strategic and innovative thinker.
- Experience in a CMC-development setting.
- Able to apply scientific principles and concepts to potential innovative platforms and disruptive technologies.
- Collaborative style, with an ability to build consensus among both internal and external stakeholders
- Embodies grit, rigor, service, EQ+IQ, builder mentality, velocity, and ownership
- Open mind regarding the future of medicine and biomanufacturing
- Able to contribute at a very high level, as well as possessing a hands-on manner, when necessary
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