Senior Manager, Manufacturing

The Senior Manager, Manufacturing will report to the Senior Director of Manufacturing and will be a part of the Clinical GMP Manufacturing Group at Alnylam's Norton Manufacturing Facility. This position is responsible for leading the manufacturing team in the execution of GMP and non-GMP manufacturing of modified oligonucleotides and siRNA Drug Substance. The role will be involved in oligonucleotide technology transfer as well as successful execution of clinical Drug Substance manufacturing campaigns.

Key Responsibilities

• Provide leadership to teams across multiple shifts to ensure staffing, onboarding, training, and development needs are met.
• Provide real-time coaching, feedback, and guidance for direct and indirect reports, holding the team accountable for execution.
• Champion a safety mindset and approach in everything we do.
• Identify personal growth opportunities for reports, and provide guidance on development plans to achieve those opportunities
• Hold direct reports and overall team accountable for meeting job expectations, performance goals, and demonstrating Alnylam's Core Values
• Foster an open culture by providing support and feedback during regular Gemba walks
• Maintain reliable, safe, and compliant delivery by establishing and enforcing Alnylam standards
• Support all phases of the DS manufacturing project life cycle, including technology transfer, clinical production, deviation evaluation and investigation, and batch disposition
• Ensure manufacturing performance, volume and quality goals are met within approved budgets by utilizing efficient methods and maintaining appropriate staffing levels
• Model a continuous improvement approach by identifying issues, taking ownership, and driving solutions
• Drive GMP Compliance and evaluate all aspects of ongoing production and understand when to intervene and escalate more significant issues for resolution
• Partner with Quality functions (internal QA/QC,) to ensure timely review of new and executed batch production records, deviations, investigations, CAPAs, and may own and drive Change Controls as needed
• Participate in 3^rd Party quality audits / inspections and own associated CAPA
• Communicate routine production manufacturing status to department head and assist as necessary with process data retrieval, processing, and analysis through written, verbal, and presentation at various meeting forums
• Represent Manufacturing on CMC teams for new product tech transfers as needed
• Provide off-shift on-call support for issues that require escalation on a rotating schedule

Qualifications

• Bachelors of Science (BS) Degree preferred with minimum 8+ years of relevant experience working in GMP Manufacturing/Contract Manufacturing in the Pharmaceutical/biotech industry as an individual contributor and 3+ years of people management experience
• Prior experience managing other people managers strongly preferred
• Strong people management, collaboration, and organizational skills required
• In-depth understanding of GMP manufacturing
• Broad knowledge of US and international regulations and standards (FDA, EMA, ICH)
• 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
• Experience with troubleshooting and providing solutions to complex technical and logistical issues
• Excellent written and verbal communication skills
• Requires proficiency in MS Office applications. Proficiency with SAP, PI Historian, LIMS, preferred.

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U.S. Pay Range

$134,600.00 - $182,000.00

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).

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: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach 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 possibleand 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, wherean authentic, inclusive culture and breakthrough thinkingfuel 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.