Upstream Process Development Jobs in Lowell, MA (NOW HIRING)

Job Description:

Company Overview

Founded over a decade ago,CRISPR Therapeuticsis 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 Therapeuticsis 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 Therapeuticshas established strategic collaborations with leading biopharmaceutical partners, includingVertex Pharmaceuticals.CRISPR Therapeutics AGis headquartered inZug,Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan 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., AKTA 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