(Contract) Specialist, CMO, External Quality Assurance

Company: Moderna Theraputics
Location: Norwood
Posted on: June 12, 2021

Job Description:

The Role:

Moderna is seeking a (Contract) Specialist of Contract Manufacturing Organization (CMO) Operations within the External Quality Assurance department based in Moderna's Norwood, MA location. The individual in this role will be responsible for providing quality support and lead Quality improvement initiative related to external manufacturing activities including DNA plasmid materials. The individual will work directly with contract manufacturing and internal functions to ensure robust processes and systems are implemented in support of Moderna's CMC commercial programs. This individual will develop and implement quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.

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

• Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories

• Review and approve validation protocols and reports to ensure compliance

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

• Support disposition of DNA plasmid materials

• Review stability protocols and reports

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

• Communicate project requirements and issues to Quality Management

• Conduct internal audits, track progress, and trend results

• Participate in supplier audits

• Support the collection of data/metrics for Management Review

• Support Contract Manufacturing sites and perform Person-in-Plant duties as required

• Review relevant sections of regulatory filings

• Provide guidance on GMP manufacturing from Phase I to Commercial

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

• BS with at least 3 years' experience, or a Master's level degree and 1-2 years' experience in the pharmaceutical/biotech industry within Quality Assurance or Quality (Assurance) exposure

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

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

• Experience working with DNA plasmid materials manufacturing preferred.

• Excellent judgment and ability to communicate complex issues in an understandable way.

• Outstanding communication skills (verbal and written).

• Auditing experience is a plus.

• Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.

• Knowledge of late-stage pharmaceutical development and validation principles preferred

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

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Keywords: Moderna Theraputics, Boston , (Contract) Specialist, CMO, External Quality Assurance, Other , Norwood, Massachusetts