Overview
Alnylam is the industry leader in the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to address the unmet needs of patients with debilitating diseases. Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality, and is now advancing a robust pipeline of investigational RNAi therapeutic medicines, including five programs in late-stage development. In 2018, Alnylam received approval for our first product, the first-ever RNAi therapeutic, by the FDA in the U.S. for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. Headquartered in Cambridge, Mass., Alnylam employs over 1,200 people in 18 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work four years in a row (2015-2018) and a Great Place to Work in the U.K. and Switzerland in 2019. Please visit www.alnylam.com for more information.
Director, External Manufacturing responsible for manufacturing technical support of specialty raw materials and API. Works closely with contract manufacturing sites to ensure reliable, compliant execution against production schedules to meet company and program goals. Monitors and reports performance indicators. Contributes to investigations and batch release activities to ensure timely delivery of key starting materials and API for further processing to ensure uninterrupted clinical and commercial supply. Hires, leads and develops employees to successfully meet group objectives. Works closely with internal functions, principally quality, supply chain and program teams, to achieve company and program objectives.

Summary Of Key Responsibilities
Work with program and process development teams to transition late stage and commercial products through the product development lifecycle.
Oversee the implementation and ongoing support of compliant cGMP manufacturing processes at raw material and API manufacturing sites.
Oversee the technology transfer for raw materials and API.
Ensure performance of manufacturing sites in process validation and inspection readiness activities.
Contribute to investigations and batch release reviews to production schedule timelines.
Oversee hiring, development, retention and optimal performance of raw material and API teams.
Responsible for driving continues improvement and operational excellence at commercial CMOs.
Lead Life Cycle Management of specialty raw material and commercial manufacturing processes to meet the needs of program and CMC team requirements.
Responsible for the development of effective and efficient working relationships with both internal and external partners.
Ensure CMO and internal compliance with cGMP and all related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports and records.
Communicate operational status regularly to senior management and program teams, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
Maintain a high level of compliance and efficiency to drive the organization to world-class manufacturing standards.
Establish an internal laboratory function to support late stage and commercial programs

Qualifications
Bachelor’s degree required; preference given to candidates with advanced degrees and degrees in engineering or science; 12+ or more years of cGMP and management experience. Proficiency in written German preferred but not required.
Global regulatory requirements for pharmaceutical manufacturing
Process development, optimization and transfer to cGMP manufacturing
Design of experiments (DOE) and associated statistical analysis
Statistical process control (SPC)
Equipment installation, qualification and validation (IQ, OQ, PQ, FAT, SOPs)
Expertise in GMP/ISO verification and validations of manufacturing processes (cGMP)
Batch record and SOP writing and review
Investigations, deviations, OOSs, and change control
Chemical synthesis, filtration, and purification
Excellent oral and written communication skills—both inside and outside the company.
Experience in working with contract manufacturing sites as well as working with collaboration partners.
Experience in the manufacture of Oligonucleotides or in the manufacture of peptides preferred.
Approximately 10% travel to CMOs and partners required.

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