Manager, Manufacturing Operations
Alnylam Pharmaceuticals
June 25, 2026
On-site
Norton, MA
Operations
Key Responsibilities
- Plan, schedule, and manage deliverables for Train 2 operational readiness and PPQ execution, including manufacturing documentation (SOPs and batch records).
- Support commissioning and qualification testing of new equipment.
- Assist with planning an efficient equipment layout and material flow.
- Ensure manufacturing schedule adherence.
- Coach, provide feedback, and guide direct and indirect reports.
- Guide teams on departmental goals and ensure goal execution accountability.
- Champion a safety mindset.
- Participate in recruiting, selecting, onboarding, and training content development/delivery.
- Identify growth opportunities and support development plans.
- Drive continuous improvement by identifying issues, owning them, and leading solutions.
- Provide support and feedback during regular Gemba walks.
- Drive GMP compliance; intervene/escalate as needed.
- Partner with Quality (QA/QC) on batch records, SOPs, deviations, investigations, CAPAs; own/drive change controls as needed.
- Participate in regulatory agency audits/inspections and own associated CAPA.
- Communicate production status and support process data retrieval, analysis, and presentations.
- Provide off-shift on-call support on a rotating basis.
- Collaborate with Engineering, Facilities, EHS, Supply Chain, Quality Assurance, Quality Control, Validation, and others.
Qualifications
- B.S. in scientific or engineering field (preferred).
- 7+ years relevant experience building a manufacturing team; GMP/contract manufacturing in pharma/biotech; 4+ years supervisory experience.
- In-depth understanding of commercial GMP manufacturing, continuous improvement, and cGMP regulations.
- Knowledge of US/international regulations (FDA, EMA, ICH); experience with government inspections for facility approval/surveillance.
- Ability to work independently; leadership and people skills in a fast-paced start-up environment.
- Strong collaboration, communication, and organizational skills.
- Experience with third-party contractors/vendors.
- Hands-on experience with plant commissioning/startup and troubleshooting complex technical/logistical issues.
- Excellent written and verbal communication.
- MS Office proficiency; SAP, PI Historian, and LIMS (preferred).
- MES/eBR experience (strongly preferred).
Benefits
- Base pay range: $117,300.00 - $158,700.00.
- Eligible for annual short-term incentive and annual long-term incentive awards.
- Plan, schedule, and manage deliverables for Train 2 operational readiness and PPQ execution, including manufacturing documentation (SOPs and batch records).
- Support commissioning and qualification testing of new equipment.
- Assist with planning an efficient equipment layout and material flow.
- Ensure manufacturing schedule adherence.
- Coach, provide feedback, and guide direct and indirect reports.
- Guide teams on departmental goals and ensure goal execution accountability.
- Champion a safety mindset.
- Participate in recruiting, selecting, onboarding, and training content development/delivery.
- Identify growth opportunities and support development plans.
- Drive continuous improvement by identifying issues, owning them, and leading solutions.
- Provide support and feedback during regular Gemba walks.
- Drive GMP compliance; intervene/escalate as needed.
- Partner with Quality (QA/QC) on batch records, SOPs, deviations, investigations, CAPAs; own/drive change controls as needed.
- Participate in regulatory agency audits/inspections and own associated CAPA.
- Communicate production status and support process data retrieval, analysis, and presentations.
- Provide off-shift on-call support on a rotating basis.
- Collaborate with Engineering, Facilities, EHS, Supply Chain, Quality Assurance, Quality Control, Validation, and others.
Qualifications
- B.S. in scientific or engineering field (preferred).
- 7+ years relevant experience building a manufacturing team; GMP/contract manufacturing in pharma/biotech; 4+ years supervisory experience.
- In-depth understanding of commercial GMP manufacturing, continuous improvement, and cGMP regulations.
- Knowledge of US/international regulations (FDA, EMA, ICH); experience with government inspections for facility approval/surveillance.
- Ability to work independently; leadership and people skills in a fast-paced start-up environment.
- Strong collaboration, communication, and organizational skills.
- Experience with third-party contractors/vendors.
- Hands-on experience with plant commissioning/startup and troubleshooting complex technical/logistical issues.
- Excellent written and verbal communication.
- MS Office proficiency; SAP, PI Historian, and LIMS (preferred).
- MES/eBR experience (strongly preferred).
Benefits
- Base pay range: $117,300.00 - $158,700.00.
- Eligible for annual short-term incentive and annual long-term incentive awards.