Roles and Responsibilities
- Represent site MSAT on project teams as a technical subject matter expert (SME) interfacing with global MSAT, Operations, and Quality.
- Develop process understanding and expertise.
- Author, review, and own process-related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc.).
- Author and review change controls; manage change implementation as assigned change agent.
- Lead or participate in investigations for process/new product implementation; drive CAPA implementation from approval to closure and effectiveness check.
- Monitor and report process performance data analysis.
- Provide 24/7 on-call support activities during production.
- Apply Operational Excellence principles to lead continuous improvement for downstream process improvements.
Position Requirements
- Masterβs (or Bachelorβs) degree in Engineering with 2+ (5+) years of pharmaceutical/biotech experience, including 2β4 years supporting downstream purification activities for biopharmaceutical products.
- Proven GMP pharmaceutical/biotechnology leadership and self-directed leadership.
- Technical purification and solution preparation using disposable-based manufacturing technologies.
- Demonstrated ability to work with high-performing teams, drive change, and influence stakeholders.
- Strong interpersonal, team, and collaboration skills.
- Excellent English verbal/written communication; interface with all organizational levels.
- Experience leading risk assessment/risk management for pharmaceutical products and processes; experience applying Quality by Design.
Benefits (as stated)
- Discretionary annual bonus; Medical, Dental, Vision; short- and long-term disability; company-paid basic life insurance; 401k match; flexible work; paid time off and paid holiday; wellness and transportation benefits.