Director, Specification

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<p><strong>Overview:</strong></p><p>The Director, Specification will be responsible for leading release and stability specifications development according to control strategy for Alnylam clinical programs. A successful candidate will be accountable for authoring and/or review of regulatory submission specification sections and provide inter-departmental oversight of activities ensuring life-cycle management of specifications internally and at contract manufacturers. This role will collaborate with a cross-functional group of leaders across Process Development, Analytical Development, Stability, Quality, CMC, and Regulatory.</p><p><br></p><p>This position is <strong><em>onsite </em></strong>and will be located at <strong><em>our Kendall Square offices in Cambridge, MA. </em> </strong></p><p><br></p><p><strong>Responsibilities:</strong></p><ul><li>Propose and lead development of specifications for drug substance, drug product, placebo, diluent, starting materials and critical raw materials for Alnylam programs in clinical development until programs transitioning to commercial stage according to control strategy.</li><li>Lead and oversee Specification Review Board (SRB) meetings and moderate the discussions, ensuring that specifications are first presented to CMC team for alignment prior to SRB endorsement.</li><li>Interact directly with internal and external auditors/inspectors from regulatory agencies and partners.</li><li>Author technical reports in support of proposed specifications.</li><li>Oversee initiation and completion of specification change controls.</li><li>Manage changes throughout product life cycle.</li><li>Author and/or review specification sections for regulatory submissions and respond to regulatory agencies/partners inquiries.</li></ul><p><br></p><p><strong>Qualifications:</strong></p><ul><li>MS or PhD in Chemistry, Biochemistry, Pharmacology or related discipline. Advanced degree preferred.</li><li>Minimum 10 years of industry experience, with a least 4 years of relevant experience in specification. Previous Quality Control / GMP experience is highly preferred.</li><li>Preferred – experience with LC and physico-chemical test methods of oligonucleotides. Alternatively - experience with LC and physico-chemical test methods of oligosaccharides or proteins.</li><li>Strong skills in the application of statistical methods.</li><li>Direct involvement in material specification setting and justification is required.</li><li>Experience working at a multi-site company and/or with CMOs is helpful.</li></ul><p><br></p><p><strong>U.S. Pay Range</strong></p><p><strong>$193,300.00 - $261,500.00</strong></p><p><br></p><p>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).</p><p><br></p><p>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.</p><p><br></p><p><em>Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: <u>https://www.alnylam.com/careers</u></em></p><p><br></p><p><strong>About Alnylam</strong>:</p><p>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: <em>fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people</em>. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.</p><p><br></p><p>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.</p>

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