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Head of Process Development, Delivery

4 months ago

Norwood, United States Biospace Inc. Full time
Job DetailsThe Role:Moderna is seeking a veteran biotechnology leader with deep experience in the development of biopharmaceutical manufacturing processes to assume the Head of Process Development, Delivery role. This critical position is responsible for leading a diverse and high-functioning team of scientists and engineers to develop manufacturing processes for the companys portfolio of lipid nanoparticle drug delivery systems; the role is also responsible for synthetic process development for Modernas portfolio of custom-synthesized small molecules.Reporting to the Senior Vice President, Technical Development, this role is critical to advancing novel drug delivery technology from Research to the clinic and on to late phase development and commercialization as a member of the Technical Development Leadership Team the role also plays a significant role across the function.Heres What Youll Do:Technical leadership and innovation: Using a deep understanding of scientific and engineering principles and extensive experience in bioprocessing, biomanufacturing, and the development of biological products, lead the development of manufacturing processes for both lipid particles for nucleic acid delivery and a variety of small molecule components. Experience with manufacture of nanoparticles and small molecules is highly desirable. As an innovative scientist or engineer, you have a track record of developing novel solutions for a wide variety of complex technical challenges, with substantial experience in design of experiments, quality by design, and statistical principles for process development. You have substantial knowledge of regulatory requirements related to biopharmaceutical process development and manufacturing.Leadership and management skills: You have substantial experience leading and organizing large scientific and engineering teams, including strategic planning, resource allocation and management, and budgeting. You obsess over learning , and drive a team culture of innovation. You drive productive decision making, removing viscosity to encourage collective action and leading imaginative solution development. You are skilled at developing talent at all levels, including managing other leaders. You have experience translating broad corporate and department objectives into a compelling technology vision and concrete action plans; and can manage a complex and rapidly changing portfolio of development projects.Communication and collaboration: You have outstanding communications written and oral communication skills, including the ability to convey complex technical information to a variety of audiences, from executive management to health care authorities. You are a preferred partner, and drive a culture of collaboration across functions, including with research, quality and regulatory affairs.Here's What You'll Bring to the Table: PhD in Chemical Engineering or ChemistryMinimum of 15 years of experience in the biopharmaceutical industry, with extensive experience in process development of complex products.Experience with process development for both small molecules and biologics, ideally including:route scouting and optimization, process optimization and scaleup for small moleculesexperience with particulate drug delivery systems such as lipid or polymeric nanoparticles, microparticlesOutstanding written and oral communication skillsExtensive experience with team leadership of medium and large teams, including leading other leaders.Thorough understanding of pharmaceutical regulatory requirements and best practices. Experience communicating complex technical strategies in regulatory documentation.Thorough understanding of quality systems in the pharmaceutical industry; ability to define best practices for compliance in a development setting.Broad understanding of and ability to operate effectively across the CMC function.Proven ability to work collaboratively across functions, including leadership of cross functional teams (for example, with Research, Quality, Regulatory Affairs, Supply Chain).Ability to effectively manage a complex portfolio of technical projects, including the development of complex research plans and dynamic realignment of timing and resources enable the pursuit of multiple options in parallelAbility to act with dynamic range , maintaining simultaneously a strong detail orientation and deep knowledge of technical activities and a strategic view of department 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:Vacation, sick time and holidaysVolunteer time to participate within your communityDiscretionary year-end shutdownPaid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extrasAbout ModernaSince 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 applyModerna 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 leavesandaccommodations@modernatx.com . (EEO/AAP Employer)-

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