Specialist, External QA, Downstream CMO Operations, 1st Shift

The Role:

This role is an exciting opportunity to provide support of GMP manufacturing from Phase 3 to Commercial. The (Contract) Specialist will be responsible for building working relationships with external CMO stakeholders (e.g. Chemistry, Manufacturing Science & Technology, Analytical, Quality Control) to perform ongoing quality assurance responsibilities in support of the manufacture, testing, and release of products. He/she will work with the Quality Systems Team to identify and support continuous improvement opportunities. This position will be 1st shift from 7:00 am to 5:00 pm working Sunday through Wednesday.

Here’s What You’ll Do:

• Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.)

• Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met

• Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans

• Support disposition of finished intermediates/drug substances

• Review stability protocols and reports

• Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations

• Generate targeted metrics for Management Review

• Provide support of GMP manufacturing from Phase 3 to Commercial

Here’s What You’ll Bring to the Table:

• MS with a minimum of 1 year experience or a BS/BA with a minimum of 2-5 years’ experience in Biotech, Pharma or Clinical Research Organization.

• Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

• Experience working with CROs, vendors, and relationship management preferred.

• Good Manufacturing Practices per 21 CFR Part 210, 211, Eudralex Vol 4.

• Concepts from Analytical Method Development per ICH Q2(R1)/FDA Guidelines

• Quality System Experience: Change Management/Change Controls, Deviations/ investigations, CAPAs, Gap Analysis.

• Knowledgeable on Biologic’s Downstream Manufacturing Processes (TFF, Chromatography Columns, and DS Final Fill)

• Experienced with process and method validation

• Excellent judgment and ability to communicate complex manufacturing and testing issues in a scientifically sound and understandable way.

• Outstanding communication skills (verbal and written).

• Ability to manage multiple projects in a fast-paced cGMP environment.

• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

About Moderna :

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.