Technical Fellow Job at Moderna Therapeutics
The Role:
Moderna is seeking a Fellow, Technical Development to provide cross-functional matrix-team leadership for individual Technical Development Teams. The Technical Development organization is comprised of scientists, engineers, and problem solvers that develop and implement the most innovative, advanced, and robust platform processes and analytical technologies to deliver Moderna’s medicines. This role involves leading one or more program-focused Technical Development Teams (TDTs), with overall accountability for defining and successfully delivering the end-to-end technical development strategy for a program within Moderna’s mRNA portfolio. As the technical lead for the program, this person will partner with the CMC program lead, representing Technical Development within the core program teams. To be successful in this role you’ll work highly cross-functionallly across Technical Development and beyond, including GMP Operations, Supply Chain, Finance, Portfolio Operations, Quality, Regulatory, and R&D Strategy. The role is based in Moderna’s new Moderna Technology Center campus in Norwood, MA, but may require presence at the Cambridge site.
Here’s What You’ll Do:
Provide cross-functional team leadership, developing and delivering the end-to-end technical program strategy from clinical development through to regulatory approval. The TDT Leader is appointed during the early- to mid-stages of development of a program within the portfolio, and is the single-point accountable person for all technical and scientific aspects during the development lifecycle.
Lead the cross-functional TDT in developing the physical product, manufacturing processes, and control strategies, establishing the supply chain, and delivering appropriate sections of CMC regulatory filings needed to enable clinical studies and ultimately, commercial launch.
Collaborate effectively and transparently with functional lines and other stakeholders within Moderna, (TD, Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Clinical and Commercial Manufacturing, Project Leadership, Portfolio Operations, etc.).
Leverage strong scientific and engineering principles in collaboration with functional area leadership, program management, quality, and regulatory personnel, etc., to develop a phase-appropriate, risk-based development strategy for execution, from clinical development through to commercialization.
Ensure the Technical Development functional areas and manufacturing partners are proactively aware of the development strategy and supply chain needs and plans for the program, communicating and ensuring that the appropriate resource, capacities, and capabilities are available to deliver an acceptable pharmaceutical product throughout the lifecycle of the project.
Assess and integrate the multi-disciplinary scientific knowledge for the program, ensuring that development plans are appropriate and that the physical pharmaceutical product meets the needs of the patient.
Highlight and maintain the program technical risk register, developing appropriate mitigation plans cross-functionally in collaboration with functional area SMEs and TDT team members.
Lead timely Technical Development and CMC-Level governance reviews of a program at relevant internal forums, as needed. Communicate technical updates and escalate risks to the TD leadership team, external partners, and CMC strategy team as needed.
Accept overall accountability for integration of technical content and strategy in regulatory submissions. Hold author, reviewer, approver, responsibility for appropriate CMC sections of regulatory submissions.
Mentor and develop the Technical Development Team members to function effectively as functional area representatives in cross-functional teams and collaborations.
Here’s What You’ll Bring to the Table:
PhD in Chemical/Biochemical Engineering, or a related discipline with technical experience relevant areas to Moderna’s mRNA platform.
Experience with cGMP, process development/ scale-up and methods /process validation, preparation of regulatory submissions, is preferred with 10+ years of industry experience in process development and/or manufacturing sciences and technology.
Demonstrated success leading cross-functional teams. Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
Prior experience in a fast-paced environment with demonstrated ability to leverage external collaborations with industry and academic partners
Demonstrated understanding of the Development Lifecycle from R&D through commercialization, including an understanding of the interdependencies of functional groups.
Strong technical/scientific experience in Product Development and commercialization
Experience in late-stage Development and project management, including strong communication skills and ability to operate effectively in ambiguity by anticipating and balancing needs of multiple stakeholders
Demonstrated experience managing interdisciplinary development teams and skilled at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.
Current knowledge of US, EU, Japan and ICH regulatory requirements among others.
Strong written and oral communication skills
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
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer) #LI-AG1
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Moderna is seeking a Fellow, Technical Development to provide cross-functional matrix-team leadership for individual Technical Development Teams. The Technical Development organization is comprised of scientists, engineers, and problem solvers that develop and implement the most innovative, advanced, and robust platform processes and analytical technologies to deliver Moderna’s medicines. This role involves leading one or more program-focused Technical Development Teams (TDTs), with overall accountability for defining and successfully delivering the end-to-end technical development strategy for a program within Moderna’s mRNA portfolio. As the technical lead for the program, this person will partner with the CMC program lead, representing Technical Development within the core program teams. To be successful in this role you’ll work highly cross-functionallly across Technical Development and beyond, including GMP Operations, Supply Chain, Finance, Portfolio Operations, Quality, Regulatory, and R&D Strategy. The role is based in Moderna’s new Moderna Technology Center campus in Norwood, MA, but may require presence at the Cambridge site.
Here’s What You’ll Do:
Provide cross-functional team leadership, developing and delivering the end-to-end technical program strategy from clinical development through to regulatory approval. The TDT Leader is appointed during the early- to mid-stages of development of a program within the portfolio, and is the single-point accountable person for all technical and scientific aspects during the development lifecycle.
Lead the cross-functional TDT in developing the physical product, manufacturing processes, and control strategies, establishing the supply chain, and delivering appropriate sections of CMC regulatory filings needed to enable clinical studies and ultimately, commercial launch.
Collaborate effectively and transparently with functional lines and other stakeholders within Moderna, (TD, Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Clinical and Commercial Manufacturing, Project Leadership, Portfolio Operations, etc.).
Leverage strong scientific and engineering principles in collaboration with functional area leadership, program management, quality, and regulatory personnel, etc., to develop a phase-appropriate, risk-based development strategy for execution, from clinical development through to commercialization.
Ensure the Technical Development functional areas and manufacturing partners are proactively aware of the development strategy and supply chain needs and plans for the program, communicating and ensuring that the appropriate resource, capacities, and capabilities are available to deliver an acceptable pharmaceutical product throughout the lifecycle of the project.
Assess and integrate the multi-disciplinary scientific knowledge for the program, ensuring that development plans are appropriate and that the physical pharmaceutical product meets the needs of the patient.
Highlight and maintain the program technical risk register, developing appropriate mitigation plans cross-functionally in collaboration with functional area SMEs and TDT team members.
Lead timely Technical Development and CMC-Level governance reviews of a program at relevant internal forums, as needed. Communicate technical updates and escalate risks to the TD leadership team, external partners, and CMC strategy team as needed.
Accept overall accountability for integration of technical content and strategy in regulatory submissions. Hold author, reviewer, approver, responsibility for appropriate CMC sections of regulatory submissions.
Mentor and develop the Technical Development Team members to function effectively as functional area representatives in cross-functional teams and collaborations.
Here’s What You’ll Bring to the Table:
PhD in Chemical/Biochemical Engineering, or a related discipline with technical experience relevant areas to Moderna’s mRNA platform.
Experience with cGMP, process development/ scale-up and methods /process validation, preparation of regulatory submissions, is preferred with 10+ years of industry experience in process development and/or manufacturing sciences and technology.
Demonstrated success leading cross-functional teams. Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
Prior experience in a fast-paced environment with demonstrated ability to leverage external collaborations with industry and academic partners
Demonstrated understanding of the Development Lifecycle from R&D through commercialization, including an understanding of the interdependencies of functional groups.
Strong technical/scientific experience in Product Development and commercialization
Experience in late-stage Development and project management, including strong communication skills and ability to operate effectively in ambiguity by anticipating and balancing needs of multiple stakeholders
Demonstrated experience managing interdisciplinary development teams and skilled at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.
Current knowledge of US, EU, Japan and ICH regulatory requirements among others.
Strong written and oral communication skills
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
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer) #LI-AG1
-
Please Note :
www.epokagency.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.epokagency.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.