Manager, Manufacturing Operations

OverviewThe Manager, Manufacturing Operations is an integral part of the Norton Internal Manufacturing team. This role will initially be involved in the start-up of Norton’s new commercial Drug Substance manufacturing train, including support for equipment commissioning & qualification, oligonucleotide technology transfer, successful execution of Drug Substance PPQ batches all the way through commercial production and launch. The successful candidate will build and manage multiple shifts for commercial GMP manufacturing in the new train. This position is an on site role in Norton that will report to the Associate Director of Manufacturing – Lead End User.Key ResponsibilitiesPlans, schedules, and manages deliverables for Train 2 operational readiness and PPQ execution, including development, ownership, and approval of manufacturing documentation (SOP’s and batch records)Supports commissioning and qualification testing of new equipment, as neededAssists with planning and directing an efficient layout of equipment and flow of materialsEnsures manufacturing schedule adherenceProvides coaching, feedback, and guidance for direct and indirect reportsProvides guidance to direct and indirect reports regarding departmental goals. Ensures accountability for goal executionChampions a safety mindset and approachMaintains staff by participating in recruiting, selecting, and orienting new hires, including development and delivery of training contentIdentifies personal growth opportunities for reports, and provides guidance on development plans to achieve those opportunitiesModels a continuous improvement approach by identifying issues, taking ownership, and driving solutionsFosters an open culture by providing support and feedback during regular Gemba walksDrives GMP compliance and understands when to intervene and escalate more significant issues for resolutionPartners with Quality functions (internal QA/QC,) to ensure timely review of new and executed batch production records, SOPs, deviations, investigations, CAPAs, and may own and drive change controls as neededParticipates in regulatory agency audits / inspections and owns associated CAPACommunicates routine production manufacturing status to department head and assists as necessary with process data retrieval, processing, analysis, and presentation at various meeting forumsProvides off-shift on-call support for issues that require escalation on a rotating scheduleCollaborate with Engineering, Facilities, EHS, Supply Chain, Quality Assurance, Quality Control, Validation, and others to support above responsibilitiesQualificationsB.S. in scientific or engineering field preferredMinimum 7+ years of relevant experience hiring and building a manufacturing team and working in GMP Manufacturing/Contract Manufacturing commercial plant in the Pharmaceutical/ biotech industry with 4+ years of supervisory experienceIn-depth understanding of commercial GMP manufacturing, continuous improvement, and cGMP regulations.Broad knowledge of US and international regulations and standards (FDA, EMA, ICH). Exposure to government inspections (FDA, EMEA, etc.) for new facility approval or routine surveillance required.Proven ability to work independently, leadership aptitude, and good people skills with the desire and ability to work in a fast-paced, start-up environmentStrong collaboration and team-building, communication, and organizational skills requiredExperience working with third party contractors and vendorsHands-on experience with plant commissioning and startup, including troubleshooting and providing solutions to complex technical and logistical issues is requiredExcellent written and verbal communication skillsRequires proficiency in MS Office applications. Proficiency with SAP, PI Historian, and LIMS preferredPrior experience with MES/eBR strongly preferred#LI-LJ1#LI-OnsiteU.S. Pay Range$117,300.00 - $158,700.00The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: AlnylamWe are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer. #J-18808-Ljbffr