The Executive Director, Drug Product Manufacturing Science and Technology (MS&T) will be accountable for successfully executing technology transfers, new product and facility introductions, process performance qualifications, and continuous verification at both external and internal sites to ensure sustained stable process performance. This leader and their team are responsible for providing technical support to commercial manufacturing operations (investigations, change controls, CAPAs, process capability), and identifying and delivering on process improvement / product lifecycle activities. The leader will work closely with crossfunctional peers to enable excellence in manufacturing that results in safe, high quality, high reliability, and a culture of continuous improvement.
The leader is also responsible for building, developing, and coaching a strong technical team, as well as establishing new strategic capabilities within the organization aligned to the company's long range plan.
The leader will sit on the global drug product leadership team and will help build the business unit strategy to ensure long-term success. This leader will be accountable to develop and execute technical plans to ensure the teams are delivering to the site strategy.
Purpose (what will this role accomplish):
- Translate science into highly reliable, efficient, and cost-effective manufacturing processes
- Proactively identify opportunities and avoid technical issues
- Right first time tech transfers
- Govern process changes/improvements across the supply network to ensure platform consistency.
(biggest difference this role will make):
Here's What You'll Do:
- Seamless new variant introductions for seasonal products
- Smooth introductions of new manufacturing capacity and business unit capabilities
- Create a culture of continuous improvement
- Ensure processes are efficient and capable to reliably deliver to patients
Here's What You'll Bring to the Table:
- Build and provide direct coaching, mentoring and development of drug product MS&T team to ensure a high performing team of scientists and engineers that embodies action orientation, timely and effective communication, accountability, and a sense of urgency. Inspire team to achieve goals that meet the immediate and longer-term business needs.
- Provide technical and scientific support and training to the entire drug product business unit.
- Active change agent, promoting a flexible and open, global mindset that embraces new opportunities, challenges the status quo, and drives excellence across the company.
- Establish strategic goals and objectives that drive MS&T responsibilities, organizational performance, and team development.
- Drive collaboration within the business unit, with Technical Development, and across the internal and external network. To ensure alignment of best practices and know-how across the product lifecycle
- Work with other business unit leaders to establish strategic plans and objectives.
- Leverage team's technical skills and process knowledge to participate and/or lead investigations through to root cause determination. Collaborate with impacted groups to develop and execute effective CAPAs.
- Continuously monitor, analyze, optimize, and ensure validation of ongoing production and cleaning processes.
- Collects and analyses process and product data using advanced digital tools to develop insights for process optimization and process reliability. Work with Manufacturing and CMOs to ensure data transfer is timely and accurate.
- Ensure materials (and changes to materials) used in manufacturing meet Quality standards, meet technical standards, and comply with Global regulatory submissions.
- Work closely with the Technical Development (TD) group to ensure the design, characterization, and scale up of processes, instruments & equipment are executable by manufacturing operations when moving into full-scale manufacturing. Partner with TD to ensure the successful translation and integration of process knowledge into manufacturing operations.
- Collaborate with Manufacturing to ensure their operations are set up for success through the provision of high quality batch records, robust processes and new technology. Anticipate, respond to and permanently resolve issues that arise during production through use of process and product monitoring.
- Support Business Development and Procurement by providing technical expertise for 'process fit' evaluations.
- Remains current in regulatory expectations and industry practices regarding investigations, CAPAs, and continued process verification including combination products
- Authors and reviews Module 3 sections for global regulatory submissions
- Education requirements:
- A BS in engineering or sciences and 25+ years of experience in technical and/or manufacturing in a biotechnology environment. Or
- A MS in engineering or sciences and 20+ years of experience in technical and/or manufacturing in a biotechnology environment. Or
- A PhD in engineering or sciences and 15+ years of experience in technical and/or manufacturing in a biotechnology environment.
Critical competencies for Success
- Extensive experience leading a technical organization with demonstrated success in building a high performing team.
- Technical expertise in drug product process technologies and their relationship with GMP manufacturing operations and process validation.
- Detailed understanding of CMC and commercial manufacturing and the related quality systems (change control, deviations investigations, etc.).
- Exceptional problem solving skills, including the ability to drive the resolution of complex issues and navigate uncertainty where analysis of events or data requires an in-depth knowledge of process and equipment performance.
- Strong verbal and written communication skills and the ability to influence at all levels
- Build trustful and effective relationships.
- Executive communication skills and financial acumen
- Think strategically and translate strategies into actionable plans.
- Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing.
Executing for Results
- The ability to create and articulate an inspiring vision for the organization, not only for the areas they are directly responsible for, but the entire drug product business unit.
- The inclination to seek and analyze data from a variety of sources to support decisions, identify opportunities and to align others with the overall strategy.
- An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.
- A passion for learning that cascades and energizes through the team.
- 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 science-based approach to making decisions; the ability to act in a transparent and consistent manner while always considering what is best for the organization.
Relationships and Influence
- 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.
- 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.
(critical results this role es expected to achieve in the next 12 to 18 months):
Things which should no longer be part of this role going forward
- Right first time NPI and reliable release of batches on-time and in-full to enable a successful seasonal campaigns
- Building of a strong technical drug product MS&T team capable to achieve our company aspirations
- Partnering with TD, Manufacturing, Supply and Quality to develop scientifically sound, efficient and reliable risk-based strategies for end-to-end drug product process design/characterization, execution and delivery.
(Activities to transition over the next 3-12 months):
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Focus on documentation (authors of low to med risk / complexity change controls and deviations)
- 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 year-end shutdown
• 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.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 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.