Sr. Specialist, Manufacturing
Sr. Specialist, Manufacturing
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Role:
ModernaTX Inc. seeks a Sr. Specialist Manufacturing for its Norwood Massachusetts location.
Heres What Youll Do:
Determine root cause of DNA Drug Substance and Drug Product Manufacturing issues using Root Cause Analysis tools.
Practice and promote safe work habits and adhere to safety procedures and guidelines.
Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues deviations non-conformances and unexpected events.
Lead cross-functional teams to drive complex investigation close outs determine root causes and implement appropriate Corrective and Preventive Actions (CAPAs).
Conduct document revisions and/or document management including batch production records and manufacturing procedures.
Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues.
Follow-up on requests issues and projects and report statuses to manager/working teams.
Perform of metric trending using software dashboards such as Spotfire and Tableau.
Generate technical protocols and reports and support internal and external audits.
Manage deviation records through the Moderna electronic Quality Management System.
Lead cross-departmental technical investigations to troubleshoot and resolve manufacturing issues.
Train new deviation writers to investigate and manage Good Manufacturing Practices (GMP) manufacturing deviation records.
Heres What Youll Bring to the Table:
Minimum requirements:
Requires a Masters degree or foreign equivalent in Biotechnology Chemistry or a related field and 2 years of experience as a Validation Specialist Release Technician QA Specialist Product Development Associate Intern Change Control or related position.
In the alternative employer will accept a Bachelors degree or foreign equivalent in the specified fields and 4 years of the specified experience.
Must have at least 1 year of experience with:
Quality assurance and validation in support of pharmaceutical production;
Working with cGMP regulations for biopharmaceutical production processes;
Creation utilization and implementation of Quality Systems including CAPAs deviations investigations change controls SOP review & batch record review; and
Equipment & Process Validation.
Apply at (Job ID: R17994) or email resume and cover letter to with subject line: R17994.
#DNI
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 a suite of voluntary benefit programs to support your unique needs
- A holistic approach to well-being with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
- Savings and investment opportunities
- Location-specific perks and extras
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.
#LI-KP1-
Required Experience:
Senior IC
Employment Type
Full-Time
