Executive Director, Drug Substance Operations
Leadership of clinical and commercial cross-functional operations overseeing the end-to-end production of mRNA drug substance. Leads multiple workcenter teams responsible for drug substance from Moderna’s Norwood, MA Manufacturing Facility. Accountable for ensuring ongoing clinical and commercial supply, as well as new product introductions to enable advancement of the pipeline and company strategy. Accountable for the development, implementation, and ongoing support of manufacturing business systems and production activities. Leads a cohesive team of workcenter and support leaders responsible for manufacturing of mRNA-based medicines. Applies existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with adherence to a Quality System informed by global regulatory expectations. Plays a vital role in the continuing operations and maturation of our new Norwood, MA facility by procuring equipment, developing SOPs, improving electronic batch records and training materials. Oversees the hiring, training and capability building, team development and engagement a high-performing and flexible organization.
Here’s What You’ll Do:
Ensure safe and compliant operations for the end to end production of mRNA medicines at the Norwood, MA facility
Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies
Manage people and equipment resources effectively to ensure agility to meet overall business needs.
Set clear objectives, monitor and report on performance of your cross-functional team in key areas including Safety, Quality, Delivery, Inventory, and Productivity. Mitigate and escalate risks to the appropriate level
Coordinate and integrate the activities of upstream and downstream operations and cross-functional partners to ensure alignment in scope, schedule and budget. Ensure resources are being utilized on the most impactful activities.
Foster a strong operations culture which is inclusive, collaborative, engaged, compliant, safety minded and highly personally accountable. Coach team for positive inter-departmental collaboration.
Build and develop a high-performing operations team, ensuring the right skills and capabilities are added at the appropriate time during periods of rapid growth.
Drive continuous improvement activities and operational excellence, including reduction of cycle time, cost, and deviations
Responsible for establishing the budget and maintaining control of costs
Here’s What You’ll Bring to the Table:
A BS in engineering or sciences and 15+ years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment. Or
A MS in engineering or sciences and 12-15+ years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment. Or
A PhD in engineering or sciences and 10-12+ years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment.
Critical Competencies for Success:
In terms of the performance and personal competencies required for the position, we would highlight the following:
The ability to create and articulate an inspiring vision for the organization, not only for the areas they are directly responsible for, but the enterprise.
The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.
The ability to effectively balance the desire/need for broad change with an understanding of how much change the organization is capable of handling, to create realistic goals and implementation plans that are achievable and successful.
A passion for learning and science that cascades and energizes through the team.
Executing for Results
The ability to set clear and challenging goals while committing the organization to improved performance, tenacious and accountable in driving results.
Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
A risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks.
A leader who is viewed by others as having a high degree of integrity and forethought in their approach to making decisions; the ability to act in a transparent and consistent manner while always considering what is best for the organization.
The ability to attract and recruit top talent, motivate the team, delegate effectively, celebrate diversity within the team, and manage performance; widely viewed as a strong developer of others.
The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from followers.
A leader who is self-reflective and aware of their own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.
Relationships and Influence
Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in their beliefs, and active drive.
Encourages others to share the spotlight and visibly, celebrates and supports the success of the team.
Creates a sense of purpose/meaning for the team that generates followership beyond their own personality and engages others to the greater purpose for the organization.
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
• Discretionary winter shut down
• Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 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!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
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 committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#LI-AG1