Senior Specialist, Analytical Technical Operations

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 89,900 - 143,800; Full time

Benefits offered by this job

Competitive healthcare

Family planning benefits

Generous paid time off

Job summary

Initial Therapeutics, Inc. is seeking an individual responsible for enabling efficient analytical execution across CMC Development programs. This includes strategic planning, stability study management, and digital operations support.

The ideal candidate will have a Bachelor's degree in a related field and 6-8 years of experience in biotechnology or pharmaceuticals. They will be critical in driving operational excellence and ensuring that analytical activities align with program objectives.

Qualifications

• 6-8 years of experience in biotechnology or pharmaceuticals.
• Experience in managing stability studies and analytical testing programs.
• Strong project management and organizational skills.

Responsibilities

• Develop and maintain analytical testing schedules for CMC Development activities.
• Author and manage stability protocols for mRNA and LNP drug candidates.
• Collaborate with partners on forecasting and testing strategies.

Skills

Analytical Operations & Planning

Project Management

Communication Skills

Data Analysis

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related field

Tools

LabVantage

Benchling

Job description

The Role

The Individual is responsible for enabling efficient analytical execution across CMC Development programs through strategic planning, stability study management, and digital operations support. This role serves as a key operational partner, translating inputs from multiple laboratory and business systems into executable testing plans while ensuring analytical activities are aligned with program priorities, timelines, and development objectives.

Working across Analytical Development, Process Development, and other CMC functions, the Candidate drives operational excellence through process optimization, automation, and digital integration initiatives. The role combines scientific understanding, project coordination, and data-driven decision-making to support stability programs, accelerate development timelines, and deliver high-quality analytical data that informs critical product development and regulatory decisions.

What You'll Do

• Develop and maintain integrated analytical testing schedules by consolidating inputs from multiple digital systems, program priorities, and laboratory capacity to support CMC Development activities.
• Author, review, and manage stability protocols and studies for novel mRNA and Lipid Nanoparticle (LNP) drug candidates, supporting shelf‑life determination, IND‑enabling studies, and product development milestones.
• Generate, review, trend, and interpret analytical data; perform peer data review; prepare technical summaries and data packages; and communicate results and recommendations to stakeholders across CMC Development.
• Manage multiple program timelines simultaneously, ensuring testing milestones, study deliverables, and reporting commitments are completed on schedule.
• Collaborate with cross‑functional partners to support forecasting activities, stage‑appropriate testing strategies, sample management, and development program planning.
• Design and implement digital tools, automated workflows, and operational processes that improve efficiency, enhance throughput, and support scalable analytical operations.
• Lead efforts to integrate new digital capabilities and improve connectivity between laboratory and enterprise systems, enabling more effective planning and execution.
• Maintain accurate and compliant documentation while partnering with analytical scientists and technical teams to support method understanding and successful execution of analytical activities.

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

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline.
• 6‑8 years of experience in biotechnology, pharmaceuticals, analytical development, technical operations, or CMC Development.
• Experience managing stability studies, analytical testing programs, or laboratory operations within a regulated environment.
• Experience working with LabVantage, Benchling, or similar laboratory information management (LIMS), electronic laboratory notebook (ELN), and data management systems.
• Strong project management, organizational, and problem‑solving skills with the ability to manage multiple priorities in a fast‑paced environment.
• Excellent written and verbal communication skills with experience presenting technical data to diverse stakeholders.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Experience supporting mRNA, LNP, biologics, or other advanced therapeutic modalities.
• Knowledge of CMC Development, stability programs, and regulatory requirements supporting IND submissions and product development.
• Experience with process automation, workflow optimization, data visualization, or digital transformation initiatives.
• Demonstrated ability to analyze, trend, and interpret analytical data to support scientific and operational decision‑making.
• Experience leading or supporting cross‑functional programs and projects, including planning, prioritization, stakeholder management, risk mitigation, and execution against key milestones.

Key Competencies

• Analytical Operations & Planning
• Stability Study Management
• Digital Systems & Automation
• Cross‑Functional Collaboration
• Project & Program Management
• Data Analysis & Technical Reporting
• Continuous Improvement
• Scientific Problem Solving
• Technical Communication

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 $89,900.00 - $143,800.00. 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

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.