113 applicants
Editas Medicine · 3 days ago
Process Engineer, Formulation Development
Cambridge, MA
Full-time
Onsite
Senior Level
4+ years exp
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Responsibilities
Lead or support experiments for RNP, mRNA/LNP manufacturing process definition, scale-down model qualification, process characterization/optimization and scale-up to meet clinical and commercial material demand
Support the generation of representative materials for analytical method development and toxicology studies
Support technology transfer of mRNA/LNP manufacturing process to internal or external manufacturing facilities for clinical and commercial manufacturing, in collaboration with Manufacturing and Quality teams
Collaborate with AD to generate data for formulation studies, stability studies, and characterization of drug substance and/or drug product
Provide technical support for engineering and cGMP manufacturing campaigns (e.g. batch record review, change control management, deviation investigation, etc) in collaboration with other line functions (e.g., Manufacturing Sciences & Technology), as needed
Document all experimental work, supporting information, and data in an electronic lab notebook (eLN) in a timely manner
Compile and present data, and assist in authoring and reviewing of batch records, work instructions, protocols, plans, technical reports, SOPs, and may contribute to regulatory document drafting and review
Cross-train personnel on processes, and provide guidance to junior team members, as required
Maintain abreast latest industry trends for RNP, LNP and nucleic acid-based process and product knowledge
Contribute to equipment procurement, setup and training
Other responsibilities as required.
Qualification
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Required
Bachelor's experience in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related discipline with 6+ years of relevant experience or Master's with 4+ years of experience.
Strong technical expertise and meaningful hands-on experience in mRNA/LNP formulation development, scale-up and/or manufacturing in a drug development setting are required.
Proficient UFDF/Dialysis operation skills with solid understanding of scale-up principles
Proficient verbal communication and technical writing skills.
Preferred
Solid knowledge and experience with QbD and common risk assessment tools for process development and characterization are highly preferred.
Working knowledge of general downstream purification techniques (e.g. depth filtration, Chromatography) is a plus.
Experience in molecular biology and microbial manufacturing of nucleic acids or protein are preferred.
Experience in Technical Transfer of cGMP manufacturing processes and regulatory filing support for biologics.
Working knowledge of mRNA, LNP and pertinent raw material (e.g. lipids) characterization methods and specifications is highly preferred.
Strong organizational skills with the ability to multi-task, problem-solve, and adjust priorities to meet goals in a fast-paced environment.
Benefits
Blue Cross Blue Shield PPO Medical Plan
Health Savings Account
Dental and Vision Insurance
Life and Disability Insurance
Dependent Care Account
Tuition Reimbursement
401(k) plan with company match
Employee Stock Purchase Plan
Employee Assistance Plan
Wellness Programs
Flexible Paid Time Off policy
Company
Editas Medicine
Editas Medicine is a clinical-stage genome editing company that develops genomic medicines for serious diseases.
201-500 employees
H1B Sponsorship
Editas Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (2)
2022 (7)
2021 (10)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$931.6MKey Investors
Boris NikolicJuno Therapeutics
2023-06-14Post Ipo Equity· $125M
2021-01-21Post Ipo Equity· $231M
2020-06-23Post Ipo Equity· $215.6M
Leadership Team
Gilmore O'Neill
CEO
Erick Lucera
Chief Financial Officer
Recent News
2024-06-04
2024-06-04
Company data provided by crunchbase
