Associate Director, Clinical Drug Supply Operations

The Role:

Moderna is seeking an Associate Director, Clinical Drug Supply Operations to act as Subject Matter Expert. This position will drive process and best practice for clinical packaging and integrate our internal label and pack agenda including the build out of our facilities. The successful candidate has deep subject matter expertise as clinical label and packaging operation including label generation.

Heres What Youll Do:

• Drive best practice for label and packaging operations including facility design

• Acts as Subject Matter Expert for all label and packaging related trouble shooting and Deviation Investigations

• Will lead operational readiness for facility start up including oversee training of operators

• Act as integration point with various stakeholders to ensure seamless process from operations through quality, project management and clinical supply/distribution.

• Develop and compile KPI (metrics) for the GMP label and pack operations

• Primary interface with CMC Portfolio Operations for Production Planning & Distribution; supports the develops best practice for translation of demand into supply

• Build and develop a high-performing manufacturing team, including operations management, ensuring the right skills are added at the appropriate time during periods of rapid growth.

• Generates, reviews, and implements processes as required and ensures compliance to relevant SOPs

• Implements industry best practices for clinical label and pack activities through SOPs and training

• Collaborates with CMC, clinical supplies team, and project management on production schedules so timing of clinical trial drug needs are met

• In collaboration with Supply Chain ensure ordering of components and labels

• In Collaboration with Technical Development & Manufacturing and Technology ensures the label and pack operations is set up as efficient process and finds ways to optimize turnaround times

Heres What Youll Bring to the Table:

• At least 8 years of GMP production management experience with deep knowledge in clinical label and packaging operation supporting global trials.

• Bachelors degree in a science-based subject (advanced degree preferred)

• Prior Cold Chain distribution experience preferred

• Creative, capable problem-solver with strong data-based decision making mindset

• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements

• Strong communication & collaboration skills. Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)

• Successful candidate will be curious in exploring new path to accelerate clinical trial material availability, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes

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.

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 persons 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.

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