Sr. Manager/ Associate Director, Quality Control, Personalized Vaccines
This role is for an experienced analytical scientist with a strong background working in a regulated (bio)pharmaceutical environment, who will have responsibility for communicating and managing the timely execution of personalized vaccines patient-specific lot release-testing. Specifically, this individual will apply strong project management and organizational skills to ensure personalized patient product lots are tested and dispositioned per accelerated timelines. Collaborating with QC analysts and managers, and the Quality Assurance team, this individual will ensure any deviations or non-conformances are appropriately addressed in timely manner, assisting with issue resolution and technical/quality systems authoring, where needed. This individual will represent the quality control organization at personalized vaccine project and cross-functional team meetings. The role requires leadership, strategic thinking, planning, a strong compliance mindset, and ability to clearly communicate key deliverables and project milestones. The ideal candidate enjoys working in a fast-paced and dynamic workplace.
Here's What You'll Do:
- Oversee and manage the timely execution of personalized cancer vaccine release tests to facilitate batch disposition under accelerated timelines
- Represent QC on cross-functional teams and communicate timelines expectations to QC area leads and QC managers
- Apply strong technical writing and risk-management skills to address deviations; collaborate with other quality teams
- Facilitate or lead root cause investigations
- Track/trend analytical data for personalized vaccine program
- Assist with quality control data review, as needed
- Ensure high quality documentation generated to support regulatory filings
Here's What You'll Bring to the Table:
- BS with 10-15, MS with 8-10, or PhD with 2-5 years of industry experience in analytical chemistry, biochemistry, biology or molecular biology, pertaining to the development of complex formulated biological or small molecule products.
- Experience in project management role, leading projects and/or project teams
- Experience in Quality Control or related cGMP/ GLP Laboratory and testing per release specifications
- Proven ability to navigate a matrix organization structure to influence without direct reporting relationships
- Knowledge of the pertinent regulatory environment, particularly USP and Ph. Eur. Methods, ICH guidelines and Code of Federal Regulations
- Strong technical-writing skills and ability to effectively document and communicate
- Interpersonal skills with an eagerness to support colleagues across the organization
- Experience in the characterization of nucleic acid products (plasmid DNA, RNA, oligonucleotides) an asset
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- 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.
- 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.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.