Employment Type : Full-Time
The Role: Reporting to the Sr. Manager of Quality Control, Bioassay, the Bioassay Quality Control Specialist will be responsible for supporting bioassay method transfer, qualification, GMP release testing, investigations and troubleshooting for QC raw material, drug substance and finished product for mRNA products produced at Moderna’s GMP manufacturing facility and affiliated contract organizations. This position will have a focus on cell-based ELISA and in vitro potency assays. The individual will teach and train analysts on the Bioassay team in the aforementioned methodologies. You will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance and Development. Here’s What You’ll Do: Act as a cell culture and potency assay subject matter expert for the team Train junior laboratory staff on Molecular Biology methods Support bioassay testing for raw materials, drug substance and drug product, including generation of testing data to support clinical studies. Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities Write/revise SOPs, protocols and reports Troubleshoot issues related to equipment, laboratory procedures and assay performance Perform general laboratory support activities including reagent preparation, equipment maintenance, etc. Establish and maintain a safe laboratory working environment Conduct technical assessments of deviations and investigations Accept, complete, and report on assignments within the agreed upon timeframe Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations Provide support to audit teams for internal and vendor audits Here’s What You’ll Bring to the Table: BS in a relevant scientific discipline with a minimum of 4 years (or MS in a relevant scientific discipline with 2 years) Quality Control experience in a cGMP organization with a focus in Mammalian Cell Culture and potency assays. Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations Knowledge and hands-on experience performing and troubleshooting potency assays Demonstrated knowledge of method qualifications/validations Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way Proven ability to conduct investigations Ability to efficiently and independently prioritize, manage and complete multiple projects and tasks in a fast-paced environment Ability to collaborate effectively in a dynamic, cross-functional matrix environment Excellent communication skills (verbal and written) Here’s What We’ll Bring to the Table: 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.