Senior Engineer, Combination Products Development
Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform.
Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines.
Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.
Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, “change the world” kind of people who are ready to say, “challenge accepted” to our mission. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company’s 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount’s 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg’s Gender Equality Index two years in a row (2021-2022), among others. At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.
The Senior Engineer, Combination Products is responsible for maintaining DHF documentation for Combination Products including Risk Management and Design Assurance, in particular in support of complaint handling and change management. This role works under the guidance of an experienced professional and collaborates with expertise areas outside of Combination Products to commercialize and maintain patient-centric Combination Products.
Summary of Key Responsibilities
- Contribute to maintenance of the design history file for Alnylam Combination Products including Design and Development Planning, Risk Assessments and Reports, Design Vertification Planning.
- Collaborate with the Combination Products Lab, Quality, Packaging Engineering, and consultants to develop documentation.
- Collaborate with Quality on assessing Supplier Change Notifications and implementing changes at Alnylam and CMOs
- Collaborate with Quality on assessing complaints on Combination Products
- Contribute to Risk Management for Alnylam’s Combination Products across Suppliers and CMOs, and Post-Launch Risk Management activities.
- Contribute to development of Design Control deliverables, including Design and Development planning and reporting, Combination Product component evaluation and selection, development of requirements and specifications, design transfer activities, and design verification planning and reporting
- Contribute to development and updates of Combination Product QMS documents and templates
- Assist in resolving findings of internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues.
- Remain up-to-date with current regulations, industry guidance, and best practices for design control activities
- Bachelor’s degree, preferably in engineering or life sciences. Advanced degree preferred but not required.
- Proven experience in a similar position
- Experience in design controls, documentation, specification development, and risk management required
- Experience in the assessment, development and/or manufacture of combination products
- Experience in assessing Change Request from suppliers and CMOs
- Experience in assessing Costumer Complaints
- Experience in authoring submission for regulators or Notified Bodies
- Excellent skills in managing own tasks and time
- Excellent documentation skills, e.g., reports, requirements, and specifications
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
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