Posted in Other 4 days ago.
The Quality control team is expanding, and we are looking for an experienced project manager and Regulatory CMC documentation Manager to join our team. In this role, the Manager will be responsible for managing the Quality Control Projects, Regulatory CMC documentation updates to support all Quality Control and Stability. The ideal candidate will support us in our mission to build a project management center of excellence within QC.
Here's What You'll Do:
Lead cross-functional teams to develop and execute the QC strategy for assigned projects; issue agendas and minutes, drive discussion, track action items, and log decisions
Proactively manage project risks and mitigation plans; follow a communication plan to escalate when necessary
Collaborate with team members to create and maintain detailed, integrated project plans; use plans to drive on-time release of materials for multiple matrixed, complex programs
Represent QC Project Management on program teams and technical development teams to ensure alignment across all functions
Prepare status updates for project review forums and communication to senior management
Participate in the development of project management best practices for the team, including creation of templates and business process improvements
Assume additional responsibilities as assigned
QC Regulatory CMC Documentation Management
Act as writer of Raw Material and Drug substance specifications and monographs within the department, including generation and management of corresponding Change controls.
Support the development, writing, and editing of QC and Stability CMC related technical data for inclusion in Module 3 of the electronic Common Technical Document (eCTD). This will include information from Standard Operating Procedures (SOPs), Batch Records, stability protocols, process validation reports, etc.
Review, prepare, manage, and lead responses to QC/Stability CMC related questions from Regulatory Authorities (such as US FDA, EMA, MHRA, Health Canada, others) as required and participate in CMC related meetings with Regulatory Authorities as needed;
Ensure applicable Quality Control policies or procedures are appropriate and establish and/or revise as necessary.
Here's What You'll Bring to the Table:
BS/BA in an appropriate discipline (e.g. sciences, engineering, business, Regulatory) with 8+ years in pharmaceutical/biotechnology development and/or project management. Advanced degree (MS, Ph.D., MBA), and/or PMP is preferred
The successful candidate will have demonstrated experience in leading cross-functional projects or programs
Ability to work in a fluid environment and foster a strong collaborative spirit
Ability to manage multiple topics in a fast-paced environment and deal with different stakeholders from different domains in the organization.
Analytical skills and system driven mind
Demonstrated ability to critically think and identify solutions.
Ability to negotiate and sustain networking relationships
Solid judgement with ability to make good decisions
Excellent written and oral communication skills
Time management and organizational skills
Strong knowledge of project management tools/software (Microsoft Project or Smartsheet), and digital solutions
Technical writing capabilities highly desirable.
Comfortable working and communicating with highly technical individuals.
Here's What We'll Bring to the Table:
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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-LG1