Overview
The Manager Manufacturing Operations is an integral part of the Norton Internal Manufacturing team. This role will initially be involved in the start-up of Nortons 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 Responsibilities
Plans schedules and manages deliverables for Train 2 operational readiness and PPQ execution including development ownership and approval of manufacturing documentation SOPs and batch records
Supports commissioning and qualification testing of new equipment as needed
Assists with planning and directing an efficient layout of equipment and flow of materials
Ensures manufacturing schedule adherence
Provides coaching feedback and guidance for direct and indirect reports
Provides guidance to direct and indirect reports regarding departmental goals. Ensures accountability for goal execution
Champions a safety mindset and approach
Maintains staff by participating in recruiting selecting and orienting new hires including development and delivery of training content
Identifies personal growth opportunities for reports and provides guidance on development plans to achieve those opportunities
Models a continuous improvement approach by identifying issues taking ownership and driving solutions
Fosters an open culture by providing support and feedback during regular Gemba walks
Drives GMP compliance and understands when to intervene and escalate more significant issues for resolution
Partners with Quality functions internal QAQC to ensure timely review of new and executed batch production records SOPs deviations investigations CAPAs and may own and drive change controls as needed
Participates in regulatory agency audits inspections and owns associated CAPA
Communicates routine production manufacturing status to department head and assists as necessary with process data retrieval processing analysis and presentation at various meeting forums
Provides off-shift on-call support for issues that require escalation on a rotating schedule
Collaborate with Engineering Facilities EHS Supply Chain Quality Assurance Quality Control Validation and others to support above responsibilities
Qualifications
B.S. in scientific or engineering field preferred
Minimum 7 years of relevant experience hiring and building a manufacturing team and working in GMP ManufacturingContract Manufacturing commercial plant in the Pharmaceutical biotech industry with 4 years of supervisory experience
In-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 environment
Strong collaboration and team-building communication and organizational skills required
Experience working with third party contractors and vendors
Hands-on experience with plant commissioning and startup including troubleshooting and providing solutions to complex technical and logistical issues is required
Excellent written and verbal communication skills
Requires proficiency in MS Office applications. Proficiency with SAP PI Historian and LIMS preferred
Prior experience with MESeBR strongly preferred
LI-LJ1LI-OnsiteU.S. Pay Range117300.00 - 158700.00
The 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.
Alnylams 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 401kwith 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 httpswww.alnylam.comcareers
About Alnylam
We 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 whats 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. Were 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.