Senior Manager, Manufacturing
Alnylam Pharmaceuticals
3 months ago
On-site
Norton, MA
Operations
Key Responsibilities
- Provide leadership to teams across multiple shifts to ensure staffing, onboarding, training, and development needs are met.
- Provide real-time coaching, feedback, and guidance for direct and indirect reports, holding the team accountable for execution.
- Champion a safety mindset and approach in everything we do.
- Identify personal growth opportunities for reports and guide development plans.
- Hold direct reports and the overall team accountable for meeting job expectations, performance goals, and demonstrating Core Values.
- Foster an open culture by providing support and feedback during regular Gemba walks.
- Maintain reliable, safe, and compliant delivery by establishing and enforcing standards.
- Support all phases of DS manufacturing project life cycle: technology transfer, clinical production, deviation evaluation/investigation, and batch disposition.
- Ensure manufacturing performance, volume, and quality goals are met within approved budgets.
- Model continuous improvement by identifying issues, taking ownership, and driving solutions.
- Drive GMP compliance; evaluate ongoing production and intervene/escalate as needed.
- Partner with Quality (QA/QC) to ensure timely review of batch production records, deviations, investigations, CAPAs; may own/drive Change Controls.
- Participate in third-party quality audits/inspections and own associated CAPA.
- Communicate routine manufacturing status and assist with process data retrieval, processing, and analysis.
- Represent Manufacturing on CMC teams for new product tech transfers as needed.
- Provide off-shift on-call support on a rotating schedule.
Qualifications
- BS preferred with 8+ years of GMP/contract manufacturing experience in pharma/biotech as an individual contributor, plus 3+ years people management.
- Prior experience managing other people managers strongly preferred.
- Strong people management, collaboration, and organizational skills.
- In-depth understanding of GMP manufacturing.
- Knowledge of US and international regulations/standards (FDA, EMA, ICH).
- Ability to work independently in a fast-paced, start-up environment.
- Experience troubleshooting and solving complex technical/logistical issues.
- Excellent written and verbal communication skills.
- MS Office proficiency; SAP, PI Historian, LIMS preferred.
Benefits (if applicable to the role)
- Medical, dental, vision; life and disability insurance; lifestyle reimbursement; flexible spending and health savings accounts; 401(k) match; paid time off, wellness days, holidays, and recharge breaks; family resources and leave.
- Provide leadership to teams across multiple shifts to ensure staffing, onboarding, training, and development needs are met.
- Provide real-time coaching, feedback, and guidance for direct and indirect reports, holding the team accountable for execution.
- Champion a safety mindset and approach in everything we do.
- Identify personal growth opportunities for reports and guide development plans.
- Hold direct reports and the overall team accountable for meeting job expectations, performance goals, and demonstrating Core Values.
- Foster an open culture by providing support and feedback during regular Gemba walks.
- Maintain reliable, safe, and compliant delivery by establishing and enforcing standards.
- Support all phases of DS manufacturing project life cycle: technology transfer, clinical production, deviation evaluation/investigation, and batch disposition.
- Ensure manufacturing performance, volume, and quality goals are met within approved budgets.
- Model continuous improvement by identifying issues, taking ownership, and driving solutions.
- Drive GMP compliance; evaluate ongoing production and intervene/escalate as needed.
- Partner with Quality (QA/QC) to ensure timely review of batch production records, deviations, investigations, CAPAs; may own/drive Change Controls.
- Participate in third-party quality audits/inspections and own associated CAPA.
- Communicate routine manufacturing status and assist with process data retrieval, processing, and analysis.
- Represent Manufacturing on CMC teams for new product tech transfers as needed.
- Provide off-shift on-call support on a rotating schedule.
Qualifications
- BS preferred with 8+ years of GMP/contract manufacturing experience in pharma/biotech as an individual contributor, plus 3+ years people management.
- Prior experience managing other people managers strongly preferred.
- Strong people management, collaboration, and organizational skills.
- In-depth understanding of GMP manufacturing.
- Knowledge of US and international regulations/standards (FDA, EMA, ICH).
- Ability to work independently in a fast-paced, start-up environment.
- Experience troubleshooting and solving complex technical/logistical issues.
- Excellent written and verbal communication skills.
- MS Office proficiency; SAP, PI Historian, LIMS preferred.
Benefits (if applicable to the role)
- Medical, dental, vision; life and disability insurance; lifestyle reimbursement; flexible spending and health savings accounts; 401(k) match; paid time off, wellness days, holidays, and recharge breaks; family resources and leave.