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Senior Engineer II, mRNA Process Development

CRISPR Therapeutics

Boston, MAFull-time$140–150K/yrPosted 3mo agoStill listed 3w ago

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At a glance

Compensation
$140–150K/yr
Location
Boston, MA
Schedule
Full-time
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Doctorate

Job overview

CRISPR Therapeutics is hiring a Senior Engineer II, mRNA Process Development. CRISPR Therapeutics seeks a highly motivated Senior Engineer II to lead design, optimization, and scale‑up of upstream and downstream unit operations for mRNA drug substance, applying DoE and statistical analysis, driving tech transfer, authoring documentation, and mentoring junior staff within a fully on‑site manufacturing environment.

Key focus areas include Lead development, optimization, and scale-up of upstream and downstream unit operations for mRNA drug substance, Apply Design of Experiments and statistical analysis to evaluate process parameters and improve yields, and Drive tech transfer of developed processes to internal clinical manufacturing teams or external CDMOs.

Successful candidates bring Ph.D. In Chemical Engineering, Ph.D. In Bioengineering, and Ph.D. In Biochemistry. Important skills include Design Of Experiments, Statistics, JMP, Minitab, Collaborative, and Undaunted. Preferred (not required): mRNA-LNP Formulation, GMP Regulations, Quality By Design Principles, and Preparing Regulatory Filing Documentation.

Skills & qualifications

RequiredNice to have

Skills

Design of ExperimentsStatisticsJMPMinitabCollaborativeUndauntedResults OrientationSense of UrgencyEntrepreneurial SpiritProactiveOwnership MindsetmRNA-LNP FormulationGMP RegulationsQuality by Design PrinciplesPreparing Regulatory Filing Documentation

Qualifications

Ph.D. In Chemical EngineeringPh.D. In BioengineeringPh.D. In BiochemistryPh.D. In Related Discipline2-4.5+ Years Industry Experience With Ph.D.10-12 Years Relevant Experience Without Ph.D.Hands-on Expertise in in Vitro Transcription KineticsHands-on Expertise in Plasmid DNA LinearizationExtensive Experience With Tangential Flow FiltrationExtensive Experience With Affinity ChromatographyExtensive Experience With IEX ChromatographyExtensive Experience With RP-HPLC

Full job description

Job Description: Company Overview Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary We are seeking a highly motivated and innovative Senior Engineer II to join our Non-viral delivery technical development team. In this role, you will lead the design, optimization, and scale-up of robust manufacturing processes for our gene editing mRNA therapeutics. You will bridge the gap between research innovation and clinical development, utilizing your deep technical expertise in nucleic acid chemistry, enzymatic reactions, and purification methodologies. As a senior member of the team, you will drive technical strategy, mentor junior staff, and collaborate closely with research innovation, analytical development, and manufacturing operations to advance our pipeline. Responsibilities Lead the development, optimization, and scale-up of upstream and downstream unit operations for mRNA drug substance. Apply Design of Experiments (DoE) and statistical analysis to systematically evaluate process parameters, improve yields, and ensure consistent product quality attributes. Drive the tech transfer of developed processes to internal clinical manufacturing teams or external CDMOs. Author clear, comprehensive technical reports, Standard Operating Procedures, batch records, and tech transfer documentation. Provide on-the-floor technical support and troubleshooting during scale-up and GMP manufacturing runs. Partner with analytical development to correlate process changes with mRNA quality attributes. Mentor, coach, and guide research associates and engineers, fostering a collaborative and high-performing laboratory culture. Represent the technical development function in cross-functional project teams and present data to senior leadership. Minimum Qualifications Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, or a related discipline with 2-4.5+ years of industry experience; OR Non PhD and 10-12 years of relevant experience Core mRNA Expertise: Hands-on, deep expertise in in vitro transcription (IVT) kinetics, plasmid DNA linearization. Downstream Purification: Extensive experience with purification techniques including Tangential Flow Filtration and various chromatography modes (e.g., Affinity, IEX, RP-HPLC). Equipment Proficiency: Experience operating automated chromatography systems (e.g., ÄKTA Avant/Pure) and filtration skids. Data Analysis: Proficiency with statistical software (e.g., JMP, Minitab) for DoE design and data analysis. Preferred Qualifications Experience with mRNA-LNP formulation. Familiarity with GMP regulations, Quality by Design principles, and preparing regulatory filing documentation. Prior experience managing or directly mentoring junior researchers. Competency Collaborative – Openness, One Team Undaunted – Fearless, Can-do attitude Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems. Entrepreneurial Spirit – Proactive. Ownership mindset. Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site. Senior Engineer II: Base pay range of $140,000 to $150,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

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