Director, Drug Product, Manufacturing Science and Technology (MS&T) 8/2/2020
JOB DESCRIPTIONAPPLY THE ROLE:
This position is part of Moderna s Manufacturing Science and Technology team responsible for ensuring the robust execution of our mRNA platform in cGMP Manufacturing. The main responsibility for this position is to lead drug product (DP) MST responsibilities for both internal and external GMP aseptic drug product manufacturing. The individual will work closely with Drug Product Process Development, Manufacturing, and Quality and external Contract Manufacturing Organizations (CMO) to successfully implement and sustain cGMP drug product manufacturing processes.
This leadership position manages a team responsible for DP manufacturing support at both Norwood as well as at CMOs. The team is responsible for technology transfer, process validation, and change control in support of new projects. The team will also sustain established processes through data monitoring, technical investigations and enabling process improvements. Success in this position requires expertise in all aspects of aseptic drug product manufacturing, the ability to work hands on, the ability to delegate and balance workload across a diverse team, and the ability to collaborate in a cross-functional, fast paced environment.
HERE S WHAT YOU LL DO:
* Support technology transfer projects including coordination of process information exchange, documentation of process parameters, and tracking process performance.
* Provide technical support of cGMP manufacturing including authoring of technology transfer documents, change control, and manufacturing investigations. Collaborate with process development on studies to determine root cause for deviations.
* Coordinate aseptic filling validation activities to ensure Moderna s aseptic filling operations meet all current regulatory requirements and guidelines.
* Assist with Regulatory submissions
* Assist in CMO selection as new manufacturing partners and projects are defined.
* Analyze manufacturing performance through data review and analyses. Author manufacturing summary reports. Collaborate with internal and external manufacturing organizations on process improvements.
* Lead the DP MST team in the USA.
* Lead cross functional technology transfer, investigation, change control, and process improvement projects.
HERE S WHAT YOU LL BRING TO THE TABLE:
* Biochemical engineer, Chemical engineer, or Biology Professional with a BS and 15-20 years of experience, MS with 10-15 years of experience, or Ph.D. with 8-10 years in a pharmaceutical or biotechnology company.
* Expertise in sterile manufacturing operations. Demonstrated experience in technology transfer and technical support of sterile processes.
* Prior experience providing technical support in a cGMP manufacturing environment.
* Prior experience managing a team
* Knowledge of single use bioprocessing technologies.
* Knowledge of data management tools and statistical analysis.
* Outstanding communication skills (verbal and written).
* Ability to manage projects in a fast-paced environment.
* Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
* Ability to adapt to new and challenging technical opportunities.
HERE S WHAT WE LL BRING TO THE TABLE:
* On-site subsidized cafeteria or catered lunches
* Company-provided iPhone
* Free parking, monthly subway pass or a subsidized commuter rail pass
* Free annual corporate membership to Bluebikes
* Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
* Flexible Spending Accounts for medical expenses and dependent care expenses
* 16 weeks of 100% paid parental leave for all new parents
* 16 weeks 100% paid family caregiver leave
* 20 weeks 100% paid medical leave
* Eligible for Moderna Month ? (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
* Adoption assistance and discounts to local childcare centers, as well as access to care.com
* 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
* A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
* Voluntary legal assistance plan
* 15 days vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.