Engineer II, Drug Product Development

Biopharma Careers; Norwood (KY); On-site; USD 74,000 - 118,000; Full time

Job summary

Moderna seeks a skilled individual to join a team developing sterile drug product processes enabling clinical and future commercial supply. You will support development activities including image development, process scale-up, container development, and scale-down studies, using ELN-based documentation and DoE-driven experiments.

The role requires a Masters or Bachelor’s degree in Chemical/Biochemical/Biomedical Engineering or Pharmaceutical Sciences, up to 2 years post-Master’s or 2+ years

Qualifications

• Masters or Bachelor’s degree in Chemical Engineering, Biochemical or Biomedical Engineering, Pharmaceutical Sciences, or related fields.
• 0–2 years post Master’s Degree or at least 2 years post Bachelor’s Degree.
• Exceptional laboratory skills in a dynamic environment.
• Knowledge of statistical design of experiments (DoE) and analysis.
• Knowledge of GMP compliance is preferred and travel up to 20%.

Responsibilities

• Conduct studies to support scale-up of drug product manufacturing (e.g. freeze/thaw, mixing, filling, filtration, lyophilization, transport).
• Develop protocols to evaluate compatibility of drug product with processing materials, containers, and sterilization processes.
• Provide support to drug product development activities with Moderna’s Pilot organization, including toxicology fills and stability fill operations.
• Plan, organize and execute experiments (using DoE where possible) and summarize results with presentations and study reports.
• Collaborate with analytical development to execute experiments and compile data.
• Support manufacturing with studies for process troubleshooting and investigations.
• Perform characterization techniques including opacity testing, microscopy, and particle sizing.
• Develop processes for long-term stability of vialed drug product and maintain ELN with good documentation practices.
• Closely collaborate with multiple groups to generate innovative formulation and process solutions.

Skills

DoE knowledge

Statistical analysis

Laboratory skills

Communication

GMP awareness

Education

Masters in Chemical Engineering

Bachelor’s in Pharmaceutical Sciences

Biomedical/Biochemical Engineering

Tools

ELN

DoE software/tools

Job description

The Role

We are seeking a highly skilled and motivated Individual, to work in a team developing Moderna’s sterile drug product processes and products that enable clinical and future commercial supply. The primary role for this position will be to support drug product development activities including: image development, process development and scale-up, container development and conditions of use studies. The incumbent will support the development of compositions, aseptic fill/finish unit operations through the development and use of scale-down models, process characterization studies etc. Applicants should have relevant pharmaceutical sciences related experience with various aspects of drug product development. The applicant should have exceptional ability to plan, execute and report, to communicate and collaborate, and requires strong attention to detail while working in a fast-paced, interdisciplinary environment.

Here’s What You’ll Do

• Conduct studies to support scale-up of drug product manufacturing (e.g. freeze/thaw, mixing, filling, filtration, lyophilization, transport etc).
• Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
• Provide support to drug product development activities executed in collaboration with Moderna’s Pilot organization, including toxicology fills stability fill operations.
• Plan, organize and execute experiments (using DoE where possible) – prepare study protocols and summarize the development results with presentations and study reports.
• Communicate and collaborate with various groups such as analytical development to execute experiments and compile data.
• Support manufacturing with studies for process trouble-shooting and investigations.
• Perform a range of routine and non-routine characterization techniques, including opacity testing, microscopy, particle sizing etc.
• Develop processes suitable to ensure long-term stability of vialed drug product.
• Maintain an up-to-date ELN with good documentation practices
• Closely collaborate with multiple groups to generate innovative solutions to challenging formulation and process problems.

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

• Education Qualifications - Masters or Bachelor’s Degree in on one of the following fields: Chemical Engineering, Biochemical or Biomedical Engineering, Pharmaceutical Sciences, or any related or sub-disciplines of the above.
• Relevant Experience: 0 – 2 years post Master’s Degree or at least 2 years post Bachelor’s Degree.
• Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment
• Knowledge of statistical design of experiments (DoE) and analysis
• Knowledge of nucleic acid chemistry and biology is a plus
• Preferred: Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
• Preferred: Experience with nanoparticle formulation technology
• Preferred: Knowledge of GMP compliance.
• Ability to travel up to 20%.

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.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

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.

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.