Back to jobs

Associate Director, CMC Technology Delivery

Cambridge, MA

Overview:

Alnylam is seeking an experienced leader to serve as Associate Director, CMC Technology Delivery to lead the digital enablement and transformation of end-to-end Chemistry, Manufacturing and Controls (CMC). This role will execute digital strategy, drive innovation, strengthen compliance, and enhance operational performance to help Alnylam CMC scale with agility and deliver business outcomes. The position reports to the Sr. Director, CMC, Manufacturing and Supply Chain Technology within the Research & Early Development (ReDev) and Technical Operations & Quality (TOQ) Technology organization.

As a recognized subject matter expert, this leader will act as hands-on IT practitioner for the CMC organization enabling scalable, compliant, and efficient processes across starting material, drug substance and drug product process sciences, analytical sciences, CMC statistics and CMC program management from preclinical to clinical and commercial launch phase. This role will partner closely with the CMC business organization, IT software and service suppliers (e.g. Software-as-a-Service, system integrators), and internal IT teams-including Data/AI, Infrastructure Services, PMO to design, implement, and continuously improve CMC digital technology solutions across their full lifecycle

Hybrid role based in Cambridge, MA, with 3 days/week onsite.

Responsibilities:

  • Define and execute the IT solutions roadmap aligned with business priorities and digital transformation goals for CMC organizations
  • Oversee the implementation and lifecycle management of digital CMC solutions that bring speed-to-market for new pipeline products from declaration of Development Candidate (DC) to regulatory filings for Investigational New Drug (IND) and New Drug Application (NDA) to commercial launch
  • Drive implementation of digital and AI/ML capabilities that enable faster and efficient regulatory authoring, bring speed and reduce error rates through digital tech transfer of Drug Substance, Drug Product, analytical methods and data, and drive insights through access to data and analytical capabilities
  • Collaborate with CMC and IT Data/AI teams to enable creation, transformation and storage of process recipe master and reference data, transactional data from lab runs, design of experiment (DOE) runs and batch execution runs, and derived data from processing of the results through statistical models and trending outputs
  • Deploy digital capabilities that enable structuring and standardizing process recipe data for Critical Process Parameters, Critical Quality Attributes, In-Process Control parameters, Normal Operating Ranges, Proven Acceptable Ranges and allow recipe version management as the chemistry tech transfers from process development to process characterization through site characterization and Process Performance Qualifications (PPQs)
  • Partner to develop data assets, AI/digital capabilities for CMC statistics for Process Development and Characterization, Process and Product Control strategy, implementing and supporting lifecycle management of trending tools
  • Enable digital capabilities that support CMC Program Management ranging from efficient transfer of programs from R&D to CMC, program start up and advancement enablement, program status reporting
  • Partner with CMC, external Contract Manufacturing Organization (CMO), Software and Services partners, and Internal IT organization to develop data products, process templates, procedures and seamless system integrations (API/EDI) to enable efficient exchange of process data
  • Proliferate user adoption of data, AI, digital and statistical analytics capabilities to accelerate use cases from research trending to Process Flow Descriptions (PFD) to regulatory specification filing, control strategy drafting, regulatory question responses to supporting commercial manufacturing for process control and monitoring, investigations and process optimization
  • Partner with the IT Data/AI team and the CMC organization to establish process data governance, process data stewardship, and process data products on the enterprise data platform to enable analytics and AI/ML capabilities for CMC operations
  • Own end-to-end accountability for the lifecycle of CMC applications - from strategy and design through deployment, sustainment, upgrades, continuous improvement, and retirement. Partner with the business to define business case and articulate outcomes, manage total cost of ownership of digital solutions
  • Ensure systems meet GxP, data integrity, and global regulatory requirements (e.g. FDA 21 CFR), maintaining audit readiness
  • Drive operational excellence by ensuring reliability, performance, compliance, and high-quality support of CMC systems (e.g., Empower, SoftMax Pro, Emerson Process Knowledge Management, QbDVision)
  • Lead and mentor a team of cross-functional and IT resources. Oversee end-to-end delivery of initiatives and build strong partnerships with business stakeholders, IT teams, vendors, and procurement

Qualifications:

  • Bachelor’s degree in Science, Engineering, Information Technology or related field
  • 10+ years of experience in CMC, Process Engineering or IT client-facing roles for CMC and Process/Analytical Development organizations in biopharmaceuticals or life sciences industry
  • Experience with some of the following: regulatory filing process, understanding of recipe unit operations and data structures, statistical software and analytical trending tools (e.g. multi-variate data analysis, assay and control charts, JMP, Minitab, R, Python, SIMCA batch-on line, SEEQ, etc.)
  • Exceptional stakeholder management and influencing skills with operations leaders and scientist user base. Change management and transformation leadership
  • Experience with data and systems integration, analytics, working with system integrators and managing IT suppliers
  • Experience in regulated environments (GxP, computer systems validation, FDA 21 CFR regulations)
  • Knowledge of full System Development Life Cycle (SDLC) - requirements, design, implementation, integration and testing, release and deployment, operations & maintenance, decommissioning
  • Demonstrated success building and leading cross-functional teams
  • Strategic mindset with a pragmatic approach - balancing long-term vision with reliable delivery of measurable business outcomes
  • 10% travel maybe required

Preferred

  • Master’s degree, MBA or PhD
  • Working knowledge of EDI, APIs, system integration and data transfers
  • Experience with Agile & Scrum methodologies, leveraging Jira (or similar tools) for tracking projects risks, issues, tasks and user stories, and project management best practices.
  • Familiarity with emerging AI, data and digital capabilities (data models, data lakehouse architecture, knowledge graphs, agentic AI, LLMs)

 

About Alnylam

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: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

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.

Before applying, please review Alnylam's ⁠Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

The pay range below 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).

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.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

U.S. Pay Range

$172,200 - $233,000 USD

Create a Job Alert

Interested in building your career at Alnylam Pharmaceuticals? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...
Select...
Select...
Select...

*Note: Fixed Term Contractors please apply via the Internal Careers page

Select...
Select...

State Specific Applicant Notices

  • Arizona Applicants: To the extent required by applicable law, the Company maintains a smoke-free workplace.
  • Maryland Applicants:
    • UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
    • The Company considers this Application for Employment to be a part of the personnel record.
  • Massachusetts (MA) Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
  • Rhode Island (RI) Applicants: The Company is subject to Chapters 29-38 of Title 28 of the General Laws of Rhode Island, and is therefore covered by the state's workers' compensation law.
Select...

I understand the Company may obtain, without using the services of a third party investigative consumer reporting agency, public records pertaining to my character, general reputation, personal characteristics or mode of living during its evaluation of my application for employment and, if employed, during my employment.  

Select...

I acknowledge that I have read and understand the California Applicants Notice set forth above and confirm that I waive my right to receive copies of public records obtained by the Company under California Civil Code section 1786.53. 

Select...

Acknowledgement 

I have read and fully understand the questions asked in this application.  I certify that all of the answers I have given are true, accurate and complete.  I understand that the falsification, omission and/or misrepresentation of any fact from or on this application or during any interview will result in immediate rejection of my application or if I am hired will be cause for immediate dismissal.  I authorize the Company and its agents, including consumer reporting agencies, to independently inquire about, investigate and obtain copies of any records which relate to me from my former employers and educational institutions, and otherwise verify any of the information provided by me during the application process.  To the fullest extent allowable under applicable law, I hereby release the Company and all affiliated persons and entities, as well as any person or institution that provides the Company with any lawful information about me, from any and all liability whatsoever resulting from any such lawful independent inquiry, investigation or communication.

If hired, I understand that I will be required to abide by all of the rules and regulations of the Company.  I understand that nothing in this application shall constitute an offer, a contract or a guarantee of employment for a specific period of time.  If hired, I understand that my employment may be terminated with or without cause and with or without notice at any time, at the will of the Company or me, unless otherwise provided by applicable law.  I further understand that no representative or agent of the Company, other than the Chief Human Resources Officer has the authority to enter into any agreement for employment, on an individual or collective basis, for any specific period of time, or to make an agreement contrary to the foregoing.  I also understand that any agreement modifying at-will employment status, on an individual or collective basis, must be in writing and signed by the Chief Human Resources Officer.  In addition, I understand that the Company and all plan administrators shall have the maximum discretion permitted by law to administer, interpret, modify, discontinue, enhance or otherwise change all policies, procedures, benefits or other terms and conditions of employment.

US - Voluntary Self-Identification of Veteran Status

Invitation to Self Identify
EEO is the Law Poste

Why are you being asked to complete this form?

A "disabled veteran" is one of the following:

A veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or

A person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to.

Protected veterans may have additional rights under USERRA—the Uniformed Services Employment and Reemployment Rights Act. In particular, if you were absent from employment in order to perform service in the uniformed service, you may be entitled to be reemployed by your employer in the position you would have obtained with reasonable certainty if not for the absence due to service. For more information, call the U.S. Department of Labor's Veterans Employment and Training Service (VETS), toll-free, at 1-866-4-USA-DOL.

If you believe you belong to any of the categories of protected veterans listed above, please indicate by checking the appropriate box below. As a Government contractor subject to VEVRAA, we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA.

Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information provided will be used only in ways that are not inconsistent with the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended

The information you submit will be kept confidential, except that (i) supervisors and managers may be informed regarding restrictions on the work or duties of disabled veterans, and regarding necessary accommodations; (ii) first aid and safety personnel may be informed, when and to the extent appropriate, if you have a condition that might require emergency treatment; and (iii) Government officials engaged in enforcing laws administered by the Office of Federal Contract Compliance Programs, or enforcing the Americans with Disabilities Act, may be informed.

Select...