We are seeking a highly skilled and motivated Senior Research Associate / Engineer II in Drug Product Development, to work in a team developing Modernas 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.
Heres What Youll Do:
Conduct studies to support scale-up of drug product manufacturing (e.g. freeze/thaw, mixing, filling, filtration, transport etc).
Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
Interface closely with Manufacturing Sciences and Technology (MS&T) and External Manufacturing organizations to execute and support clinical and commercial technology transfers to internal and external facilities
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.
Heres What Youll Bring to the Table:
Education Qualifications - Masters or Bachelors 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 Masters Degree or at least 2 years post Bachelors 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.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
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 proud to be an equal opportunity workplace and is an affirmative action employer.
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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at email@example.com. (EEO/AAP Employer)