Company:
BioSpace, Inc.
Location: Norwood
Closing Date: 07/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Job Details
The Role
The Associate Specialist in Moderna's Drug Product team plays a critical role in producing high-quality mRNA-based medicines. This position requires a strong understanding of cGMP regulations and biopharmaceutical production processes, particularly in DNA operations, mRNA, or Fill Finish operations. The Associate Specialist will support day-to-day operations through deviation and CAPA writing, ensure compliance with quality standards, and participate actively in problem-solving and process improvement initiatives.
Heres What Youll Do
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.
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.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
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 contact the Accommodations team at . (EEO/AAP Employer)
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The Role
The Associate Specialist in Moderna's Drug Product team plays a critical role in producing high-quality mRNA-based medicines. This position requires a strong understanding of cGMP regulations and biopharmaceutical production processes, particularly in DNA operations, mRNA, or Fill Finish operations. The Associate Specialist will support day-to-day operations through deviation and CAPA writing, ensure compliance with quality standards, and participate actively in problem-solving and process improvement initiatives.
Heres What Youll Do
- Adhere to and promote safe work practices, following safety procedures and guidelines.
- Perform real-time batch record and documentation review on the production floor.
- Identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events using investigative and analytical skills.
- Collaborate with specialists and senior specialists to effectively close out higher-level investigations.
- Participate in cross-functional teams to drive the closure of complex investigations, identify root causes, and implement appropriate CAPAs.
- Conduct revisions and manage manufacturing documents, including batch production records and procedures.
- Engage in forums for continuous improvement, gathering requirements, and prioritizing issues.
- Follow up on operational requests, issues, and projects, providing status updates to management and teams.
- Participate in metric trending and the generation of technical protocols and reports.
- Support both internal and external audits to ensure regulatory compliance.
- Operate independently with minimal supervision, making decisions that require discretion and judgment
- Education: Bachelors degree in Engineering, Life Sciences, or a related field.
- Experience: At least 1+ years in biopharmaceutical operations, with hands-on experience in cGMP manufacturing environments.
- Specific Certifications or Training: Training in cGMP practices; familiarity with 21 CFR part 11 is advantageous.
- Other Quantifiable Preference: Demonstrated ability to manage multiple tasks in a fast-paced environment and excellent written and oral communication skills. Experience with electronic batch records is preferred.
- This position is site-based, requiring you to be at Modernas site full-time. This position is not eligible for remote work.
- 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!
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.
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.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
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 contact the Accommodations team at . (EEO/AAP Employer)
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BioSpace, Inc.