Development Director Job at Moderna Therapeutics
The Role:
Moderna’s Drug Product Development team is seeking an experienced, innovative and accomplished leader. Drug product development is responsible for ensuring the translation of mRNA technology in to successful dosage forms and commercial products from a pharmaceutical sciences and engineering perspective. The incumbent will lead a device and secondary packaging development group as part of the Drug Product Development (DPD) leadership team. The lead will have oversight of combination product development and secondary packaging development activities for Moderna products for global markets, including design validation, human factors engineering validation, material screening and selection, package design, qualification, tech transfer and support of regulatory filings. This candidate will be responsible for both technical and organizational leadership aspects of device and packaging development, to advance Moderna’s exciting mRNA pipeline and technology platforms.
Here’s What You’ll Do:
Lead, develop, inspire and mentor a group of scientists and engineers focused on enabling device design for Moderna’s device and combination product applications and developing robust packaging solutions for Moderna’s product portfolio.
Lead matrixed Drug Product teams to advance device and packaging development initiatives and implementation.
Provide technical oversight for the design, execution, and documentation of appropriate device development, verification, and validation studies, design history file generation and human factors engineering validation activities and documentation.
Provide scientific and technical packaging expertise and oversight for the design and development of robust packaging systems including packaging component definition and process definition.
Review and approve the secondary packaging component specifications, test procedures, manufacturing procedures, and equipment qualification protocols and reports as per site requirements.
Be a part of the DPD leadership team and contribute to charting the future direction and growth of the organization, hiring, resourcing, budget, investments etc.
Interface with and influence key stakeholder organizations including MS&T (US and International), External Manufacturing, Quality and Regulatory to develop and execute on strategies for commercialization of late-stage programs.
Directly manage a team of Scientists and Engineers facilitating personnel growth, development and subject matter expertise. Provide technical mentorship to junior scientists/engineers.
Advance platform and functional initiatives through direct contributions and matrixed leadership
Drive authoring and review of regulatory submissions
Here’s What You’ll Bring to the Table:
Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline
Minimum of 10 years (PhD), 14 years (MS), 16 years (BS) industry experience in biopharmaceutical development
Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas
Demonstrated expertise working with a range of biopharmaceutically relevant devices such as pre-filled syringes, injection devices and respiratory delivery devices.
Experience in combination product device development and commercialization, including working closely with external CDMOs.
Experience leading the medical device design control and development process, including risk management, design transfer and sustaining manufacturing / engineering activities
Experience in developing and commercializing regulated devices/combination products under Design Control (21 CFR 820 or ISO 13485) and ISO 14791 requirements
Understanding of global industry standards (ex. ISO, ASTM, etc.) and working knowledge of the medical device regulatory environment and applicable regulations
Knowledge and understanding of material manufacturing and converting, product/packaging interaction, barrier properties, stability, global pharmaceutical packaging regulations, and package testing
Prior management and mentorship experience; passion for people management and development
Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities
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’s Drug Product Development team is seeking an experienced, innovative and accomplished leader. Drug product development is responsible for ensuring the translation of mRNA technology in to successful dosage forms and commercial products from a pharmaceutical sciences and engineering perspective. The incumbent will lead a device and secondary packaging development group as part of the Drug Product Development (DPD) leadership team. The lead will have oversight of combination product development and secondary packaging development activities for Moderna products for global markets, including design validation, human factors engineering validation, material screening and selection, package design, qualification, tech transfer and support of regulatory filings. This candidate will be responsible for both technical and organizational leadership aspects of device and packaging development, to advance Moderna’s exciting mRNA pipeline and technology platforms.
Here’s What You’ll Do:
Lead, develop, inspire and mentor a group of scientists and engineers focused on enabling device design for Moderna’s device and combination product applications and developing robust packaging solutions for Moderna’s product portfolio.
Lead matrixed Drug Product teams to advance device and packaging development initiatives and implementation.
Provide technical oversight for the design, execution, and documentation of appropriate device development, verification, and validation studies, design history file generation and human factors engineering validation activities and documentation.
Provide scientific and technical packaging expertise and oversight for the design and development of robust packaging systems including packaging component definition and process definition.
Review and approve the secondary packaging component specifications, test procedures, manufacturing procedures, and equipment qualification protocols and reports as per site requirements.
Be a part of the DPD leadership team and contribute to charting the future direction and growth of the organization, hiring, resourcing, budget, investments etc.
Interface with and influence key stakeholder organizations including MS&T (US and International), External Manufacturing, Quality and Regulatory to develop and execute on strategies for commercialization of late-stage programs.
Directly manage a team of Scientists and Engineers facilitating personnel growth, development and subject matter expertise. Provide technical mentorship to junior scientists/engineers.
Advance platform and functional initiatives through direct contributions and matrixed leadership
Drive authoring and review of regulatory submissions
Here’s What You’ll Bring to the Table:
Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline
Minimum of 10 years (PhD), 14 years (MS), 16 years (BS) industry experience in biopharmaceutical development
Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas
Demonstrated expertise working with a range of biopharmaceutically relevant devices such as pre-filled syringes, injection devices and respiratory delivery devices.
Experience in combination product device development and commercialization, including working closely with external CDMOs.
Experience leading the medical device design control and development process, including risk management, design transfer and sustaining manufacturing / engineering activities
Experience in developing and commercializing regulated devices/combination products under Design Control (21 CFR 820 or ISO 13485) and ISO 14791 requirements
Understanding of global industry standards (ex. ISO, ASTM, etc.) and working knowledge of the medical device regulatory environment and applicable regulations
Knowledge and understanding of material manufacturing and converting, product/packaging interaction, barrier properties, stability, global pharmaceutical packaging regulations, and package testing
Prior management and mentorship experience; passion for people management and development
Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities
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 :
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, 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.