Engineer II, Process Development

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 74,000 - 118,400; Full time

Benefits offered by this job

Competitive healthcare

Generous paid time off

Family planning benefits

Job summary

Initial Therapeutics, Inc. is seeking a dedicated Scientist or Engineer to contribute to mRNA medicines development. The role involves executing late-stage process characterization studies, supporting technology transfer, and collaborating with multiple teams for regulatory submissions.

The ideal candidate will have a strong background in bioprocess development and excellent troubleshooting and communication skills. A holistic benefits package is provided, emphasizing well-being and career growth within an innovative organization.

Qualifications

• BS with minimum of 3+ years, MS with 1+ years in bioprocess development.
• Background in process development (late-phase preferred).
• Excellent communication, presentation, and writing skills.

Responsibilities

• Execute late-stage process characterization studies.
• Independently plan, execute, troubleshoot, and document experiments.
• Collaborate cross-functionally with various teams.

Skills

Bioprocess development

Experimental execution

Technical documentation

Data analysis

Cross-functional collaboration

Education

BS in Chemical Engineering, Chemistry, Biochemical Engineering, or related field

Tools

AKTA FPLC

HPLC/UPLC instrumentation

Job description

The Role

Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. We seek an Individual to join the Late-Stage Execution team within the Process and Product Development – Registrational organization. This role will support late-stage process characterization, technology transfer, validation readiness, and commercial regulatory filing activities for Moderna’s mRNA medicines.

The successful Candidate will contribute to the development and execution of robust, scalable, and well-characterized manufacturing processes across RNA, LNP, and related unit operations. This is a lab-based role requiring strong experimental execution, technical documentation, data analysis, and cross-functional collaboration with Process Development, Analytical, Manufacturing, Quality, Regulatory, Supply Chain, and Program Management teams.

This role is well suited for a proactive scientist or engineer who can independently plan and execute experiments, troubleshoot process challenges, maintain high-quality source documentation, and help translate process knowledge into regulatory-ready technical packages.

Here’s What You’ll Do

• Execute late-stage process characterization studies supporting registrational and commercial filings.
• Independently plan, execute, troubleshoot, and document experiments supporting RNA, LNP, and related process unit operations.
• Support development and evaluation of robust, scalable, and well-characterized manufacturing processes using Quality by Design (QbD) principles, risk assessments and experimental data.
• Contribute to process robustness studies, scale-down model development, scale-up studies, technology transfer, and process validation readiness.
• Analyze and interpret experimental data using appropriate statistical, visualization, and modeling tools.
• Maintain high-quality electronic lab notebooks, protocols, technical reports, and source documentation suitable for regulatory filings and inspection readiness.
• Collaborate cross-functionally with Analytical Development, Manufacturing, Quality, Regulatory, Supply Chain, and Program Management teams to meet program milestones.
• Present technical results, risks, and recommendations in internal and cross-functional forums.
• Collect, organize, archive, and coordinate process samples for downstream analytical testing.
• Identify process gaps, troubleshoot technical challenges, and propose practical, data-driven solutions.

• Ensure all activities are performed in accordance with site SOPs, GxP expectations, and environmental health and safety standards.

Here’s What You’ll Need (Basic Qualifications)

• Education and Experience: BS with minimum of 3+ years, MS with 1+ years of relevant industry experience in bioprocess development and/or manufacturing sciences with a degree in Chemical Engineering, Chemistry, Biochemical Engineering, Biochemistry or closely related scientific field.
• Background in process development (late-phase preferred) and/or process characterization
• Working knowledge of bioprocess engineering principles, process modeling, and Design of Experiment (DoE) statistical tools.
• Ability to plan and execute experiments independently with minimal guidance
• Excellent communication, presentation, and writing skills
• Creative/innovative/problem solver
• Preferred: Experience with nanoparticle formulations or mRNA manufacturing
• Preferred: Familiarity with nucleic acid and protein chemistry, enzyme kinetics, and analytical characterization of biomolecules
• Preferred: Experience/education in biotechnology process/product development.
• Preferred: Hands on experience with AKTA FPLC, Hamilton, Tangential flow filtration (TFF), HPLC/UPLC instrumentation and pump systems (e.g. Metler-Toledo).

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you - at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].

Export Control Notice

Export Control Notice: This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.