Leadership of key strategic projects, including facility planning & start up enabling the clinical Drug Production strategy. In addition, this role will be also the creator & owner of various business processes supporting clinical Drug product operations effectiveness such as training, SOP and batch record improvements etc. This leader will directly lead a small team of specialist while leading many broader project teams indirectly. This role requires deep subject matter expertise across various disciples of Drug product operation including different presentations.
Here’s What You’ll Do:
Accountable to deliver approved projects as they pertain to Drug product. That includes facility start up projects as well as expansion & establishment of new drug product capabilities.
Lead all Production support activities including SOPs, training, batch record readiness etc
Act as liaison with MST and DP development to proactively define clinical drug product capability roadmap and also incorporate learnings from commercial DP operation
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.
Support the Sr. Director of clinical DP operations in building 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
Here’s What You’ll Bring to the Table:
BS or equivalent and 10-15 years of experience in the pharmaceutical/biotech industry, as well as demonstrated success in drug product facility start-ups. Alternatively, MS/ PhD with 8-10 years of hands on industry experience
Advanced experience in Drug Product production and start up across multiple presentations. Experience in clinical label & packaging is a plus
Demonstrated success application of operational excellence tools to support root cause investigations and identification of continuous improvement projects
Excellent ability to proactively define needed steps to operationalize goals and active driver with ability to influence cross-functionally
Strong understanding of project and business governance, business process analysis and roadmap design, as well as ability to work across multiple business functions to build consensus
Ability to connect Lean and improvement of compliance, safety, quality, delivery, and efficiency
“Hands on” and willing to step into detailed activities directly where needed
Advanced proficiency in Excel, Visio and PowerPoint to build and maintain various kinds of reports, process maps and presentations
Good judgment and ability to communicate complex issues in an understandable way.
Outstanding communication skills (verbal and written).
Ability to manage multiple projects in a fast-paced environment.
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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