Engineer III, Drug Product MS&T

ModernaTX

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profile Job Location:

Norwood, OH - USA

profile Monthly Salary: $ 89900 - 143800
Posted on: 10 hours ago
Vacancies: 1 Vacancy

Job Summary

The Role:

In this role you will be a key technical leader in the organization responsible for the development implementation and optimization of internal Drug Product operations including formulation filling inspection packaging and labeling processes to support clinical and commercial production at a new state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility

This role requires onsite presence at the Norwood MA USA facility.

Heres What Youll Do

  • Serve as a technical lead or key contributor for drug product fill-finish (aseptic manufacturing) inspection and labeling processes.

  • Provide on-the-floor support during routine operations and batch execution including support for deviations and investigations.

  • Lead troubleshooting of process or equipment-related issues collaborating with cross-functional teams.

  • Support technology transfer activities to internal or external manufacturing sites.

  • Participate in the setup qualification and troubleshooting of inspection and labeling equipment (e.g. Knapp kits visual inspection systems).

  • Assist with commissioning and validation activities during facility or equipment start-up.

  • Analyze process performance and batch data to identify trends performance variability and opportunities for improvement.

  • Support the development and optimization of inspection system recipes and parameters.

  • Author or contribute to technical documents including SOPs protocols summary reports and change controls.

  • Assist with preparation for audits and inspections providing technical input as needed.

  • Work closely with Quality Operations Regulatory and Engineering teams to support compliant and efficient GMP manufacturing.

  • Contribute to cross-functional technical assessments and process improvement initiatives.

Heres What Youll Need (Basic Qualifications)

  • BS M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry Biochemistry Chemical Engineering Pharmaceutical Engineering etc.). BS with 5 to 8 years of experience or MS with 2 to 5 years experience in a pharmaceutical or biotechnology company.

  • Experience in cGMP aseptic (sterile) fill finish operations including prior experience supporting validation of aseptic manufacturing processes.

  • Knowledge of data management tools and statistical analysis.

  • Excellent judgment and ability to communicate manufacturing issues in a scientifically sound and understandable way along with ability to provide data driven solutions.

  • A highly collaborative team player capable working in a cross-functional matrix environment.

  • Ability to manage projects in a fast-paced environment.

  • Ability to effectively collaborate effectively in a dynamic cross-functional matrix environment.

  • This position is site-based requiring you to be at Modernas site full-time. This position is not eligible for remote work.

  • At Moderna we are focused on delivering on our mission by enabling talent to thrive. For this role we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

  • Best-in-class healthcare coverage 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 investment opportunities to help you plan for the future

  • Location-specific perks and extras

The salary range for this role is $89900.00 - $143800.00. 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 individuals 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.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

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 persons 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 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

Were 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 .

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 applicants 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.

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Required Experience:

IC

The Role:In this role you will be a key technical leader in the organization responsible for the development implementation and optimization of internal Drug Product operations including formulation filling inspection packaging and labeling processes to support clinical and commercial production at ...
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Key Skills

  • APQP
  • Six Sigma
  • GD&T
  • Root cause Analysis
  • CAD
  • Project Leadership
  • SolidWorks
  • Mechanical Engineering
  • Quality Management
  • Product Development
  • Catia
  • Manufacturing

About Company

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