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location: Norwood, Massachusetts
job type: Permanent
salary: $80,000 - 100,000 per year
work hours: 8 to 4
Our team is seeking a highly skilled, motivated, and experienced bioprocess development Scientist or Engineer to join the Technical Development organization. This role will develop, scale-up, and transfer new and improved production processes for the company's first-in-class messenger RNA (mRNA) based medicines to enable our clinical supply and late stage development. Development goals will include leading process robustness studies, process characterization, process improvements, and building relationships to critical quality attributes. He/She will be expected to lead other development scientists / engineers in defining process development strategy, designing experiments, establishing critical process parameters, and implementing process control strategies. He/She will routinely collaborate through cross-functional and matrixed teams including mRNA, Lipid, Analytical Development, Statistics, and MS&T teams.
The applicant should have excellent time management and communications skills. Applicants should thrive in fast-paced, dynamic, and innovative environments. Demonstrated success in bioprocess development, technical problem solving, and tech transfer are essential. Previous experience with mRNA, chromatography, nanoparticle formulations, filtration technologies, mixing technologies, tangential flow filtration, process robustness, process characterization, and design of experiments is preferred.
We are developing mRNA-based vaccines and therapeutics. The mRNA is packaged into lipid nanoparticles for storage and delivery. The Process Development group is focused on unit operations that are standard across the industry such as normal and tangential flow filtration and chromatographic purification. We are also designing scalable operations specifically invented to form our lipid nanoparticles, to encapsulate the mRNA, and to physically stabilize the particles. RESPONSIBILITIES
- Define process development strategy, goals, and specific plans for the lipid nanoparticle process steps of mRNA therapeutics.
- Lead planning, design, execution, and analysis of process development experiments to establish process description, to evaluate critical process parameters, and to implement process control strategy.
- Compile experimental and analytical results, perform data interpretation, summarize, and report on data with conclusions and recommended next steps.
- Perform process scale-up, tech transfer and provide manufacturing support in plant.
- Contribute to process risk assessments and FMEA activities in support of late stage/commercial manufacturing process development.
- Review and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups.
- Create scaled-down and high throughput and automated experimental setups
- Characterize nanoparticle properties through collaboration with the analytical team
- Prepare process descriptions, technical reports, communicate findings internally and externally, and present in cross-functional meetings
- Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups. Optimize current processes to ensure robust manufacturing of mRNA therapeutics
- BS, MS, or PhD in Bio/Chemical Engineering, Bio/Chemistry, or closely related field
- 3-10 years of relevant industry experience in bioprocess development
- Late stage process development experience is preferred.
- Knowledge of process scale-up, scale-down model development, and process characterization.
- Hands-on experience with chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operations
- Experience in nanoparticle /large molecule/mRNA drug product process development is a plus.
- Self-motivated and driven to identify and complete assignments.
- Highly flexible mentality comfortable working in a dynamic environment - comfortable with ambiguity.
- Ability to manage people and multiple projects.
- Excellent communication skills required.
- Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data
- Experience with analytics and biophysical characterization of nanoparticles is a plus
- Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercialization
- Ability to thrive in a diverse and fast paced environment
skills: Molecular Biology, Chemistry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.