Technical Specialist

Moderna Theraputics, Cambridge Massachusetts

Moderna is seeking a Technical Specialist based at their Norwood, MA site. This individual will report to the Senior Manufacturing Manager. This position will be 2nd shift from 3:00 pm to 1:00 am Sunday through Wednesday; please note, this role is 4x10 schedule with a weekend day requirement.The individual in this role will be part of a cohesive team responsible for producing messenger RNA for evaluation in human clinical trials. The Senior Technical Specialist uses expert knowledge of manufacturing biopharmaceutical unit operations, process engineering and digital infrastructure to both operate mRNA processes as well as act as a technical leader for the team. The Senior Technical Specialist will be a key technical trainer for the team and serve as a technical expert for Manufacturing for Tech Transfers and other key projects focusing on a lean, error-proofed and digital process. They will leverage knowledge of cGMP regulations to support some investigations and improvement initiatives within manufacturing operations. This role will consist of approximately 60% of their time operating and training and 40% executing projects.Here's What You'll Do:* Practices and promotes safe work habits and adheres to safety procedures and guidelines* Utilizes manufacturing process knowledge to drive continuous improvement in process operations* Manufacturing lead for tech transfers and other projects* Directs cross functional teams to drive complex manufacturing operations changes or improvements* Conducts complex document revisions and/or document management including batch production records and manufacturing procedures* Performs training with staff on the floor* Subject matter expert for multiple processing technologies (chromatography, filtrations, digital systems, etc…)* Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology* Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.* Monitor process operations to ensure compliance with specifications.* Works independently with minimal supervision and direction* Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion* Creates and presents trending and metrics reports* Participates in equipment start-up, commissioning, and validation activities, including system owner responsibilities for equipment induction workflows and implementing changes to qualified systems* Ensures equipment operational readiness* Assists with troubleshooting in case of equipment failure, including impact assessment of out-of-tolerance records as needed* Assists with deviation investigations as the pertain to processing technology expertise and related equipment or materials* Participates in defining robust process parameters during routine manufacturing campaigns* Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaignsHere's What You'll Bring to the Table:* Bachelor's Degree with 8+ years of experience in biopharmaceutical operations* Subject matter expertise in biologics drug substance production and purification operations (chromatography, TFF, aseptic technique) or a similar complex specialized environment* 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* Bachelor's degree in Engineering or Life Sciences is preferred* 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 care.com* 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:Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.Our Mission:Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.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.#LI-PL1

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