QC Analyst II
6 month+ contract - Benefits available
The Quality Control Analyst II will work within the Quality Control Technical Service (QCTS) group, managing and maintaining the documents and quality records for late stage and commercial product specifications of Alnylam’s therapeutic programs for the management of product-lifecycles. Additionally, this role supports the CMC program teams by providing documents for a timely release of material, upcoming manufacturing campaigns, maintenance of the stability program, regulatory needs, compliance of commercial materials, and initiation of clinical trials.
A person, who is self-driven, can multi-task, has open and amiable communication style, and strongly believes in the Alnylam core values of Commitment to People, Passion for Excellence, Open Culture, Sense of Urgency, and Innovation and Discovery, would be successful in this role.
Summary of Key Responsibilities
· Manages late stage and commercial documents for the release and stability testing of Alnylam drug programs (ONPATTRO (patisiran), GIVLAARI (givosiran), OXLUMO (lumasiran), vutrisiran, and others as they advance) for internal and regional use.
· Responsible (authoring, initiation, and review) for quality records (change controls, CAPAs, deviations, SOPs, risk assessments, etc.), specifications, and justification of specification reports. Responsible for coordinating QC impact assessments as part of quality records.
· Maintains ad hoc meetings with the Specification Review Board, a cross-functional team, to support the lifecycle of early (in partnership with Analytical Sciences), late, and commercial programs.
· Supports multiple CMC program teams by providing documents in a timely manner for: product and product release, stability programs, extension of shelf life for products, and commercial launch.
· The role requires regular interactions with senior members of cross functional teams and provides project management and Subject Matter Expert (SME) knowledge for product specifications (API, drug product, intermediates, and potentially critical starting materials) to support CMC teams.
· Coordinates with Quality and Program Managers to provide project updates, workflows, and timelines. Maintains the QC department dashboard to show the current status of programs/deliverables.
· Perform data verifications (data integrity review), support analytical method validations, and perform statistical analysis of data, as needed.
· B.S. in chemistry or a related discipline
· 3+ years of experience in an industrial setting, preferably in a cGMP environment as it pertains to the biopharmaceutical industry
· Understanding and working knowledge of statistical analysis of data, lifecycle management of late-stage and commercial products, and commitment to data integrity. The successful candidate would have a good command of technical writing in English.
· Prior experience with relevant ANVISA, EMA, FDA, ICH, and JP guidelines as it pertains to drug substance and drug product specifications
· Knowledge of regulatory processes in relation to filings and marketing applications for Module 3 (amendments, CTD, IMPD, IND, NDA, MAA, etc.)
· Expertise in OOS/OOT/Atypical resolution, deviations, change controls, root cause analysis, and monitoring CAPA effectiveness would be a desirable.
· Strong collaborative, communication, and time management skills
· Sound judgement and commitment to transparency and integrity
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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