Sr. Manager, CMC Clinical Operations Integration

The Role

Reporting to the Executive Director, CMC Clinical Operations Integration, the Sr. Manager, CMC Clinical Operations Integration, is a hands-on project and stakeholder management position.

The Sr. Manager, CMC Clinical Operations Integration is accountable for the end-to-end delivery of clinical manufacturing batches. The individual in this role will be a key stakeholder manager engaging all functions in Clinical Operations to ensure the organization is on track for producing high quality mRNA-based medicines for evaluation in human clinical trials.

The Sr. Manager, CMC Clinical Operations uses expert and broad knowledge of cGMP regulations and biopharmaceutical processes to support timely delivery of clinical manufacturing batches. The Sr. Manager will also drive and lead the improvement of systems and processes with the aim of integrating the various functions in clinical manufacturing. Using your analytical and project management experiences, you will serve as an integrator of our manufacturing, and supporting groups by anticipating disposition challenges and working end-to-end to find potential opportunities to pull in deliveries or releases prior to original delivery dates.

Heres What Youll Do:

• Oversee the end-to-end value chain from raw materials to drug product delivery

• Ensure timely and compliant progression of clinical manufacturing activities

• Attend required tiers and accountable for timely escalations for any program risks

• Utilizes broad process and workflow knowledge to guide the team through resolution of program risks

• Promote inter- and intra-departmental communication to facilitate and maximize performance

• Promote and implement improvement initiatives to improve integration of cross functional communication and processes

• Attend required deviation, change control, project meetings to ensure clinical manufacturing timelines are on track to meet due dates

• Accountable for site schedule adherence tracking, reporting and analysis

• Accountable as the Point of Contact for interactions and meetings with the Clinical Portfolio Team

• Accountable for assessing cross functional and program impact from emerging manufacturing risks

• Utilize manufacturing process knowledge and investigational skills to write and project manage change controls for high priority or high complexity projects

• Provide support to influence and evolve quality systems and support continuous improvement activities.

• Follow-up on requests, issues, and projects and provide updates to senior management

• Support internal and external audits

• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion

• Practice and promote safe work habits and adheres to safety procedures and guidelines

• Ensure daily and weekly planned vs. actual measurements by tracking key performance indicators

• Collaborate with our clinical portfolio operations team to deliver on time our vaccines and therapies.

• Lead our raw material, drug substance and drug product expiry extension program

• Represent the organization in various prioritization activities using your knowledge of the lot status and risks.

• Collaborate with customers within the value stream to interpret and research expedite requests.

• Work with Suppliers and internal departments to identify and develop potential solutions

Heres What Youll Bring to the Table:

• M.S. with 5-7 years experience within Biotech, Pharma or related industries or B.S. with 8-10 years relevant experience; Degree in Engineering or Life Sciences is preferred

• Ability to develop, manage, and support multiple projects in parallel, including managing resources and communications in a fast-paced matrix environment.

• Strong cross functional acumen for assessing of cross functional impact

• A comprehensive understanding of regulatory requirements and their applications in a cGMP environment

• Minimum of 2 years experience with deviation/investigation/change control/quality management systems or a similar technical writing system in a cGMP environment

• Excellent written and oral English language skills

• Demonstrated ability to lead cross functional teams and deliver results with minimal supervision

• Experience working with electronic batch records and thorough understanding of 21 CFR part 11 requirements

• Experience working across pharmaceutical product lifecycle from development through commercial manufacturing

• Knowledge in Lean manufacturing and Six Sigma Preferred

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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