BioSpace, Inc.
Associate Director, CMC Program Management
BioSpace, Inc., Norwood, Massachusetts, us, 02062
Job Details
The Role
The CMC Program Management team in Technical Development seeks an Associate Director to lead pivotal work focusing on the design and comprehensive management of CMC program integrated project plans. The candidate is expected to be a trend setter of cross-functional communication, aligning priorities for optimal project execution while demonstrating the ability to manage and lead teams in drug discovery/development projects. The ideal candidate will have a background in science with prior experience in Manufacturing, Quality, Process Development, and/or Supply Chain organizations. This is an onsite role based in Modernas Technology Center campus in Norwood, MA.
You will leverage previous product development and commercialization experience acting as an integrating conduit between CMC functional groups in close collaboration with the CMC Franchise Lead and Team members. Your efforts will ensure seamless execution and management of program(s), with a focus on operational planning, risk management, budget oversight, and timely submissions of reports and updates. You will facilitate cross-functional communication and lead the execution of product strategies from discovery through clinical development.
Heres What Youll DoLeverage previous experience within CMC product development and commercialization to integrate between multiple functional areas, including Tech Dev, Manufacturing, Regulatory, Quality, and Supply Chain.Lead cross-functional teams or projects characterized by complexity, risk, and integration requirements across multiple functions, ensuring adherence to broader organizational goals.Influence high-level decision-making within the organization by providing comprehensive project insights and strategic recommendations.Oversee the CMC project plan to align with strategic goals and ensure timely execution.Develop project plans that integrate cross-functional inputs and support strategy execution.Manage risk registers by identifying risks and implementing mitigation strategies.Ensure action items from team meetings are completed, upholding team accountability.Organize and lead team meetings, producing concise materials to communicate key points.Provide data analysis to support strategic decisions and direction setting.Track project milestones, report progress, and keep stakeholders informed.Formulate plans for risk mitigation and scenario planning for potential challenges.Oversee project budgets, ensuring alignment with financial objectives.Lead Project Management processes, including reviews, goal setting, and commercialization strategies.Drive the enhancement of Project Management practices for organizational effectiveness.Advocate for resources to impact long-term organizational objectives, effectively managing external vendors and ensuring alignment with organizational standards.Participate in and contribute to company-wide improvement initiatives.Heres What Youll Need (Basic Qualifications)
Education: Bachelors or Masters degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical disciplineExperience: 12 years of relevant experience with a Bachelors degree or 10 years of relevant experience with a Masters degreeHeres What Youll Bring to the Table (Preferred Qualifications)
Project Management Professional (PMP) certification is preferred.Previous experience with CMC product development and commercialization is preferred.Familiarity with CMC technical processes and the overall drug development process.Strong project management skills with an agile approach to system development.Excellent communication skills and the ability to influence without authority.Proven experience in risk register maintenance and action log management.Proficiency in facilitating meetings and drafting presentation materials.Ability to lead contingency planning and scenario analyses.Advanced PowerPoint, SmartSheet, and MS Project skills.Evidence of advanced problem-solving, innovative thinking, strategic planning to deliver creative solutions.Ability to work collaboratively on multiple projects concurrently in a fast-paced environment.Excellent organizational, communication, and analytical skills with a keen attention to detail.Outstanding interpersonal skills to form and maintain strong relationships.Willingness and dedication to go above and beyond in pursuit of team goals.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 extras!
About Moderna
Since 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 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. 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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The Role
The CMC Program Management team in Technical Development seeks an Associate Director to lead pivotal work focusing on the design and comprehensive management of CMC program integrated project plans. The candidate is expected to be a trend setter of cross-functional communication, aligning priorities for optimal project execution while demonstrating the ability to manage and lead teams in drug discovery/development projects. The ideal candidate will have a background in science with prior experience in Manufacturing, Quality, Process Development, and/or Supply Chain organizations. This is an onsite role based in Modernas Technology Center campus in Norwood, MA.
You will leverage previous product development and commercialization experience acting as an integrating conduit between CMC functional groups in close collaboration with the CMC Franchise Lead and Team members. Your efforts will ensure seamless execution and management of program(s), with a focus on operational planning, risk management, budget oversight, and timely submissions of reports and updates. You will facilitate cross-functional communication and lead the execution of product strategies from discovery through clinical development.
Heres What Youll DoLeverage previous experience within CMC product development and commercialization to integrate between multiple functional areas, including Tech Dev, Manufacturing, Regulatory, Quality, and Supply Chain.Lead cross-functional teams or projects characterized by complexity, risk, and integration requirements across multiple functions, ensuring adherence to broader organizational goals.Influence high-level decision-making within the organization by providing comprehensive project insights and strategic recommendations.Oversee the CMC project plan to align with strategic goals and ensure timely execution.Develop project plans that integrate cross-functional inputs and support strategy execution.Manage risk registers by identifying risks and implementing mitigation strategies.Ensure action items from team meetings are completed, upholding team accountability.Organize and lead team meetings, producing concise materials to communicate key points.Provide data analysis to support strategic decisions and direction setting.Track project milestones, report progress, and keep stakeholders informed.Formulate plans for risk mitigation and scenario planning for potential challenges.Oversee project budgets, ensuring alignment with financial objectives.Lead Project Management processes, including reviews, goal setting, and commercialization strategies.Drive the enhancement of Project Management practices for organizational effectiveness.Advocate for resources to impact long-term organizational objectives, effectively managing external vendors and ensuring alignment with organizational standards.Participate in and contribute to company-wide improvement initiatives.Heres What Youll Need (Basic Qualifications)
Education: Bachelors or Masters degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical disciplineExperience: 12 years of relevant experience with a Bachelors degree or 10 years of relevant experience with a Masters degreeHeres What Youll Bring to the Table (Preferred Qualifications)
Project Management Professional (PMP) certification is preferred.Previous experience with CMC product development and commercialization is preferred.Familiarity with CMC technical processes and the overall drug development process.Strong project management skills with an agile approach to system development.Excellent communication skills and the ability to influence without authority.Proven experience in risk register maintenance and action log management.Proficiency in facilitating meetings and drafting presentation materials.Ability to lead contingency planning and scenario analyses.Advanced PowerPoint, SmartSheet, and MS Project skills.Evidence of advanced problem-solving, innovative thinking, strategic planning to deliver creative solutions.Ability to work collaboratively on multiple projects concurrently in a fast-paced environment.Excellent organizational, communication, and analytical skills with a keen attention to detail.Outstanding interpersonal skills to form and maintain strong relationships.Willingness and dedication to go above and beyond in pursuit of team goals.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 extras!
About Moderna
Since 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 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. 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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