- 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
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Director, Manufacturing Sciences and Technology - Norwood, United States - Moderna
Description
Director, Manufacturing Sciences and Technology page is loadedDirector, Manufacturing Sciences and Technology
Apply
locations
Norwood, Massachusetts
Drug Manufacturing
time type
Full time
posted on
Posted Yesterday
job requisition id
R15485
The Role:
This position is part of Moderna's Manufacturing Sciences and Technology (MST) team responsible for ensuring robust production of Drug Substance (DS) using our mRNA manufacturing platform at our Norwood site.
The Director/Senior Director will have full responsibility for both clinical and commercial GMP manufacturing support and be an integral member of the internal manufacturing leadership team.
Here's What You'll Do:
Lead MS&T teams supporting cGMP drug substance manufacturing of Moderna's late-stage clinical and commercial mRNA products, as well as select critical starting raw materials and starting materials
Lead MS&T teams providing technical support for process monitoring, on - floor support,
change control,
deviation investigations, and CA/PA for all DS workcenters – DNA, chemistry, small-scale clinical DS production, and large-scale clinical/commercial DS production
Lead MS&T teams providing centralized investigation and CA/PA leadership support on behalf of the internal manufacturing organization
Lead technical product stewards responsible for managing the site-based new product introduction and process qualification strategies across all technologies and scales, across the program lifecycle
Author, review, or otherwise contribute to clinical and commercial regulatory filings and health authority question responses. Support inspection readiness and response activities.
Develop MS&T strategy, plan resource needs and hire and manage employees to meet organizational needs for the present and future.
mitigations.
Collaborate extensively with Manufacturing, Quality, Digital, Technical Development, Supply Chain and others to ensure operational excellence in making product.
Obsessively focus on decreasing variability in the manufacturing environment through practical application of data and operational.
Collaborate with multiple functions to ensure the manufacturing site maintains a high state of compliance through continued improvements in raw material control, control of microbial contamination, control of consumables quality, control of cleaning, and control of equipment performance.
Monitor and improve these critical manufacturing areas through continuous monitoring, data analytics, and collaboration with QA, QC, and Facilities & Engineering.
Here's What You'll Bring to the Table:
Biochemical engineer, chemical engineer, or biological/chemistry science degree with >12+ years of experience in the pharmaceutical or biotechnology industry. Advanced degree preferred (MS, Ph.
D.)
Prior leadership experience managing MS&T, Process Development, or Technical Development groups or function for a pharmaceutical or biotechnology company. Demonstrated ability to mentor and develop a technical staff.
Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI).
Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development.
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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at. (EEO/AAP Employer)
locations
2 Locations
time type
Full time
posted on
Posted 12 Days Ago
Sr. Engineer I, Manufacturing Science and Technology
locations
2 Locations
time type
Full time
posted on
Posted 30+ Days Ago
Senior Engineer I, Manufacturing Science and Technology
locations
2 Locations
time type
Full time
posted on
Posted 12 Days Ago
At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA).
This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.
We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.
Our Mission :
To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.
Our Vision :
To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.
Third Party Staffing AgenciesM oderna does not accept unsolicited resumes from any source other than directly from candidates.
For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.
Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.
Reasonable Accommodation NoticeModerna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws.
Please inform the company's personnel representative by calling or emailingif you need assistance completing any forms or to otherwise participate in the application process.
Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
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