DS Biologics PCU lead
Sanofi
7 months ago
On-site
Framingham, MA
Operations
Main Responsibilities:
- Provide direct oversight for the Manufacturing operation.
- Ensure products are produced and stored according to current instructions; ensure practice matches procedure.
- Maintain appropriate maintenance and qualification state for equipment and facilities; keep facilities/equipment in a state of control and audit readiness.
- Ensure personnel (including contractors/consultants/temporary employees) supporting cGMP activities have necessary education, knowledge, and skills.
- Ensure all Manufacturing activities are performed in compliance with cGMPs.
- Ensure Manufacturing staff are sufficiently trained; each has an approved job description.
- Oversee Manufacturing investigations, CAPA, process variances, and deviations; ensure change control, CAPA, and deviations are completed by due date.
- Ensure control over process, equipment, and facility changes.
- Support internal and external cGMP compliance audits; establish and maintain partnering relationships with Quality.
- Ensure Manufacturing work practices follow Genzyme-Sanofi Safety Programs.
- Establish departmental and individual goals in alignment with site priorities; identify resources and implement structures/processes/communications to deliver commitments.
- Develop strategies aligned to site direction; manage and execute a production plan supporting reliable product supply while upgrading facilities/equipment and establishing capable, compliant processes.
- Lead the PCU team (APU Leadership member); define and hire resources; manage headcount and spending to budget.
- Provide technical leadership; support employee development, performance management, succession planning, and rewards/recognition.
- Lead manufacturing performance using Operational Excellence tools (e.g., LEAN-Kaizen; MDI).
- Manage scheduling employees; implement/execute/maintain manufacturing process and operations.
- Anticipate, identify, and communicate risks; support/r drive mitigation plans.
- Track performance metrics and drive continuous improvement.
Qualifications:
- Bachelor’s degree with at least 12 years of technical/operational leadership experience, OR master’s degree with technical/operational leadership experience.
- In-depth knowledge of biopharmaceutical, pharmaceutical, and/or device cGMP manufacturing (critical).
- Demonstrated ability to manage complex functional areas and achieve significant business results.
- Excellent people leadership and change leadership skills.
- Track record managing mid-to-large, complex manufacturing operations in later plant life cycle stages.
- Demonstrated ability to develop self and others; build high-performance teams.
- Excellent communication skills; ability to influence and build relationships across internal/external constituencies.
- Track record managing manufacturing operations across plant life cycle phases (start-up, growth, steady state, declining).
- Solid understanding of Health, Safety, Environmental, and legal requirements.
- Excellent problem-solving; ability to generate innovative solutions.
- Ability to set ambitious/realistic targets, drive execution, and build continuous improvement/accountability culture.
- Provide direct oversight for the Manufacturing operation.
- Ensure products are produced and stored according to current instructions; ensure practice matches procedure.
- Maintain appropriate maintenance and qualification state for equipment and facilities; keep facilities/equipment in a state of control and audit readiness.
- Ensure personnel (including contractors/consultants/temporary employees) supporting cGMP activities have necessary education, knowledge, and skills.
- Ensure all Manufacturing activities are performed in compliance with cGMPs.
- Ensure Manufacturing staff are sufficiently trained; each has an approved job description.
- Oversee Manufacturing investigations, CAPA, process variances, and deviations; ensure change control, CAPA, and deviations are completed by due date.
- Ensure control over process, equipment, and facility changes.
- Support internal and external cGMP compliance audits; establish and maintain partnering relationships with Quality.
- Ensure Manufacturing work practices follow Genzyme-Sanofi Safety Programs.
- Establish departmental and individual goals in alignment with site priorities; identify resources and implement structures/processes/communications to deliver commitments.
- Develop strategies aligned to site direction; manage and execute a production plan supporting reliable product supply while upgrading facilities/equipment and establishing capable, compliant processes.
- Lead the PCU team (APU Leadership member); define and hire resources; manage headcount and spending to budget.
- Provide technical leadership; support employee development, performance management, succession planning, and rewards/recognition.
- Lead manufacturing performance using Operational Excellence tools (e.g., LEAN-Kaizen; MDI).
- Manage scheduling employees; implement/execute/maintain manufacturing process and operations.
- Anticipate, identify, and communicate risks; support/r drive mitigation plans.
- Track performance metrics and drive continuous improvement.
Qualifications:
- Bachelor’s degree with at least 12 years of technical/operational leadership experience, OR master’s degree with technical/operational leadership experience.
- In-depth knowledge of biopharmaceutical, pharmaceutical, and/or device cGMP manufacturing (critical).
- Demonstrated ability to manage complex functional areas and achieve significant business results.
- Excellent people leadership and change leadership skills.
- Track record managing mid-to-large, complex manufacturing operations in later plant life cycle stages.
- Demonstrated ability to develop self and others; build high-performance teams.
- Excellent communication skills; ability to influence and build relationships across internal/external constituencies.
- Track record managing manufacturing operations across plant life cycle phases (start-up, growth, steady state, declining).
- Solid understanding of Health, Safety, Environmental, and legal requirements.
- Excellent problem-solving; ability to generate innovative solutions.
- Ability to set ambitious/realistic targets, drive execution, and build continuous improvement/accountability culture.