Director, Specification

Role Summary

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.

Responsibilities

• 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.
• 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.
• Interact directly with internal and external auditors/inspectors from regulatory agencies and partners.
• Author technical reports in support of proposed specifications.
• Oversee initiation and completion of specification change controls.
• Manage changes throughout product life cycle.
• Author and/or review specification sections for regulatory submissions and respond to regulatory agencies/partners inquiries.

Qualifications

• MS or PhD in Chemistry, Biochemistry, Pharmacology or related discipline. Advanced degree preferred.
• Minimum 10 years of industry experience, with a least 4 years of relevant experience in specification. Previous Quality Control / GMP experience is highly preferred.
• Preferred ‚Äì experience with LC and physico-chemical test methods of oligonucleotides. Alternatively - experience with LC and physico-chemical test methods of oligosaccharides or proteins.
• Strong skills in the application of statistical methods.
• Direct involvement in material specification setting and justification is required.
• Experience working at a multi-site company and/or with CMOs is helpful.

Skills

• Statistical analysis
• Regulatory submission preparation
• Quality systems and GMP knowledge
• Cross-functional collaboration
• Specification development and change control

Education

• MS or PhD in Chemistry, Biochemistry, Pharmacology or related discipline. Advanced degree preferred.

Additional Requirements

• Onsite role located at Kendall Square offices in Cambridge, MA.