What are the responsibilities and job description for the Manufacturing Associate II position at Moderna?
The Role
In this role, you will prepare buffers and handle of materials necessary for the processing mRNA and LMX/LNP for clinical pipeline products as well as commercial seasonal vaccines in a GMP regulated environment. A Manufacturing Associate II executes, independently and proficiently, all applicable manufacturing unit operations, as directed, following relevant standard operating procedures and cGMP regulations. The work is conducted within a clean-room environment and typically involves limited physical activity, lifting and standing for periods of time.
Here’s What You’ll Do
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks precisely. Utilizing reader-doer for all steps outlined in standard operating procedures, work instructions, and batch execution documentation. Readers are responsible for SOP and batch record compliance, verifying the actions of the Doer, and are accountable for the outcome of the tasks. Doers are responsible for task execution, are expected to understand the task's purpose and are expected to be able to anticipate system response once actions are performed.
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Working in grade C environments and ensuring the manufacturing area is clean and remains in a state of control.
Adhere to documented waste handling procedures and respect environmental regulations.
Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable.
Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.
As a Qualified Trainer, perform On The Job Training (OJTs) to accelerate the assimilation and training of colleagues on unit operations and supporting business processes.
Understands physical and digital systems governing equipment and processes to enable basic troubleshooting.
Perform specific unit operations in which they are fully trained.
Perform weighing and dispensing operations, buffer mixing, filtration and aseptic aliquoting of process related buffers.
Complete material readiness activities including ordering and kitting process materials.
Perform Clean In Place (CIP) of fixed stainless-steel equipment.
Perform Electronic Batch Record reviews (eBRs) as required.
Appropriately respond, with guidance, to process alarms based on criticality and function.
Able to approve document revisions as delegated by their manager.
Additional duties as may be assigned from time to time.
Here’s What You’ll Need ( Basic Qualifications)
Education: HS Diploma
Experience: STEM degree with 2-3 years’ industry experience or an Associates’ degree with 3-5 years’ industry experience or HS Diploma with 5 years’ industry experience
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Working understanding of GMP regulations.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna provides employees with a comprehensive and innovative suite of benefits, including :
Highly competitive and inclusive medical, dental, and vision coverage options
Dedicated guided healthcare coordination through Included Health that elevates healthcare planning for every kind of employee, including our LGBTQ employees and other underserved communities
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account to help you engage in personal enrichment and self-care activities
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Family care benefits, including subsidized backup care options and on-demand tutoring
Adoption, surrogacy, and family-planning benefits
Paid time off, including:
Generous 401k match and Financial Planning supports
Moderna-paid Life, LTD, and STD insurance, as well as voluntary benefit options
Concierge service including home services research, travel booking, and entertainment requests
Free premium access to fitness, nutrition, and mindfulness classes including e xclusive preferred pricing on Peloton fitness equipment
Free parking, subsidized parking, or subsidized commuter passes, depending on location
Location-specific perks and extras!
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:
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, 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.
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. We’re 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 leavesandaccommodations@modernatx.com . (EEO/AAP Employer)
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In this role, you will prepare buffers and handle of materials necessary for the processing mRNA and LMX/LNP for clinical pipeline products as well as commercial seasonal vaccines in a GMP regulated environment. A Manufacturing Associate II executes, independently and proficiently, all applicable manufacturing unit operations, as directed, following relevant standard operating procedures and cGMP regulations. The work is conducted within a clean-room environment and typically involves limited physical activity, lifting and standing for periods of time.
Here’s What You’ll Do
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines.
Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Execute tasks precisely. Utilizing reader-doer for all steps outlined in standard operating procedures, work instructions, and batch execution documentation. Readers are responsible for SOP and batch record compliance, verifying the actions of the Doer, and are accountable for the outcome of the tasks. Doers are responsible for task execution, are expected to understand the task's purpose and are expected to be able to anticipate system response once actions are performed.
Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
Working in grade C environments and ensuring the manufacturing area is clean and remains in a state of control.
Adhere to documented waste handling procedures and respect environmental regulations.
Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence of gowning and vision, if applicable.
Utilize the manufacturing support systems and equipment as required including, but not limited to, SAP, VEEVA, Delta V, Syncade, LIMS, CMMS.
As a Qualified Trainer, perform On The Job Training (OJTs) to accelerate the assimilation and training of colleagues on unit operations and supporting business processes.
Understands physical and digital systems governing equipment and processes to enable basic troubleshooting.
Perform specific unit operations in which they are fully trained.
Perform weighing and dispensing operations, buffer mixing, filtration and aseptic aliquoting of process related buffers.
Complete material readiness activities including ordering and kitting process materials.
Perform Clean In Place (CIP) of fixed stainless-steel equipment.
Perform Electronic Batch Record reviews (eBRs) as required.
Appropriately respond, with guidance, to process alarms based on criticality and function.
Able to approve document revisions as delegated by their manager.
Additional duties as may be assigned from time to time.
Here’s What You’ll Need ( Basic Qualifications)
Education: HS Diploma
Experience: STEM degree with 2-3 years’ industry experience or an Associates’ degree with 3-5 years’ industry experience or HS Diploma with 5 years’ industry experience
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Working understanding of GMP regulations.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna provides employees with a comprehensive and innovative suite of benefits, including :
Highly competitive and inclusive medical, dental, and vision coverage options
Dedicated guided healthcare coordination through Included Health that elevates healthcare planning for every kind of employee, including our LGBTQ employees and other underserved communities
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account to help you engage in personal enrichment and self-care activities
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Family care benefits, including subsidized backup care options and on-demand tutoring
Adoption, surrogacy, and family-planning benefits
Paid time off, including:
- Vacation, sick time, and observed Company-wide holidays
- Paid volunteer time to participate within your community
- Discretionary year-end shut down
- Paid 4-week sabbatical after 5 years, and every 3 years thereafter
Generous 401k match and Financial Planning supports
Moderna-paid Life, LTD, and STD insurance, as well as voluntary benefit options
Concierge service including home services research, travel booking, and entertainment requests
Free premium access to fitness, nutrition, and mindfulness classes including e xclusive preferred pricing on Peloton fitness equipment
Free parking, subsidized parking, or subsidized commuter passes, depending on location
Location-specific perks and extras!
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
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
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, 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.
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. We’re 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 leavesandaccommodations@modernatx.com . (EEO/AAP Employer)
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