Overview

The Suite Coordinator is accountable for operational readiness to support schedule adherence, smooth handoff of documentation and process steps with other departments, and completion of follow up actions on safety initiatives. Reporting to the Sr. Manager, Manufacturing, this role is expected to operate within the manufacturing suite up to 80% of the time and will work business hours Monday – Friday, providing overlap with all shifts.

Key Responsibilities

Manages product changeovers & cross-functional hand-offs, including drafting changeover schedules & records and coordinating activities across multiple departments including but not limited to Facilities, Validation, Quality Control and Quality Assurance.
Proactively assesses upcoming manufacturing activities and identifies & coordinates key tasks required for operational readiness.
Initiates and schedules work orders, both routine maintenance and on-demand requests, managing timelines for RTS (return to service), or rescheduling and/or justifying maintenance and calibration extensions as needed in coordination with the plant scheduler.
Drives timely completion of operational readiness documentation (i.e. cleaning verification, area clearance, equipment changeover, logbook reviews etc.).
Circulates documents to reviewers with general assistance, responds to comments and questions. Manages document review and approval to meet project timelines and provides status reports to management.
Owns key administrative duties related to readiness including processing orders and delivery of materials, inventory management & cycle counting, ordering batch records, ensuring completion RTS checklist, etc.
Proactively tracks and develops relevant performance metrics and trends and proactively reviews schedule adherence misses to identify sound countermeasures to identify future process improvements where applicable.
Supports planned interruptions to routine production process schedules and activities, including providing expertise for controlling and justifying no potential product impact (such as hatch accesses and/or wall and floor repairs).
Works with management and senior staff to determine appropriate course of action within defined procedures. Tracks ongoing problems and gathers information for analysis. Analyzes data to develop solutions to moderate-level problems.

Qualifications

BA/BS in science, engineering, or related discipline with Two (2) or more years of relevant work experience or Four (4) or more years relevant work experience in a biotech/pharmaceutical GMP manufacturing role preferred.
Strong communication and ability to manage cross-functional tasks through to completion
Ability to work in a dynamic, cross-functional environment
Proficiency with Microsoft Office applications
Proficiency with process automation software, SAP, LIMS, electronic document management system
Continuous Improvement Mindset is a must

U.S. Pay Range

$72,800.00 - $98,600.00

The pay range reflects the hourly wage 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. Pay range does not include shift differential pay if applicable. 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

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 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.

Alnylam Pharmaceuticals

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Manufacturing Suite Coordinator