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Manufacturing Specialist, Investigations and CAPAs

Moderna Theraputics

This is a Full-time position in Norwood, MA posted February 23, 2021.

The Role:Reporting to the Senior Manager, Manufacturing Specialists, this individual will be part of a cohesive team responsible for producing high quality mRNA-based medicines for commercial production and evaluation in human clinical trials. The Manufacturing Specialist uses expert knowledge of cGMP regulations and biopharmaceutical production processes to support day to day operational support through deviation and CAPA writing.Here’s What You’ll Do:* Practice and promote safe work habits and adheres to safety procedures and guidelines* Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events* Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA)* Conduct document revisions and/or document management including batch production records and manufacturing procedures* Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues* Follow-up on requests, issues, and projects and report statuses to manager/ working teams* May perform metric trending* May generate technical protocols and reports* May support internal and external audits* Work independently with minimal supervision and direction* Perform work that consistently requires independent decision making and the exercise of independent judgment and discretionHere’s What You’ll Bring to the Table:* Bachelor’s Degree with 5-8 years of experience in biopharmaceutical operations or a Master’s Degree with 0-2 years industry experience; Degree in Engineering or Life Sciences is preferred* Subject matter expertise in biologics drug substance purification operations (liquid chromatography, TFF, aseptic technique) or a similar complex specialized environment* A comprehensive understanding of investigational techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe* A comprehensive understanding of regulatory requirements and their applications in a cGMP environment* Minimum of 2 years’ experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment* Excellent written and oral English language skills* Demonstrated ability to lead cross functional teams and deliver results with minimal supervision* Ability to manage multiple competing priorities in a fast-paced environment* Experience working with electronic batch records and thorough understanding of 21 CFR part 11 requirements* Background in lean manufacturing methodologies and operational excellence* Experience interacting with representatives of regulatory agencies* Project management experienceHere’s What We’ll Bring to the Table:* On-site subsidized cafeteria or catered lunches* Company-provided iPhone* Free parking, monthly subway pass or a subsidized commuter rail pass* Free annual corporate membership to Bluebikes* 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* 16 weeks of 100% paid parental leave for all new parents* 16 weeks 100% paid family caregiver leave* 20 weeks 100% paid medical leave* Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)* Adoption assistance and discounts to local childcare centers, as well as access to* 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 (includes 2 floating holidays)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 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-PL1*