Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Discover Impactful Work:
Leadership of formulation & process development, manufacturing operations, tech writing, and planning & supply chain functions in a fast-paced contract development and manufacturing (CDMO) environment. . Oversight of scientific and technical teams developing clinical phase oral solid dosage (OSD) drug products,
A Day in the Life:
Serves as a member of the Site Leadership Team, achieving business objectives through coaching managers and supervisors and providing leadership to a team of approximately 30 people. Leading organizational change; developing and empowering staff; encouraging relationships; putting staff in a position to succeed by meeting their career goals while achieving company goals; building effective teams that apply their skills and perspectives; driving engagement and crafting a climate where employees are motivated to do their best.
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Leads the activities of the Formulation Process Development (FPD) team, ensuring the collection and interpretation of process data with scientific review to support the conclusions and recommendations in development reports. Oversees the Supply Chain team to ensure material procurement, manufacturing readiness, and scheduling activities meet customer commitments. Leads the Operations team in completing cGMP manufacturing activities.
Maintains experienced knowledge of pharmaceutical processes, equipment, instrumentation, and procedures needed to perform the tasks. Attends project team meetings to provide guidance and drive action to meet customer requirements.
Communicates and works with customers and internal partners to support business growth and develop robust products within agreed timeframes. Interacts closely with the Business Development team to scope project proposals.
Supports staff in writing high-quality protocols, batch records, and reports for customers' IND applications and other regulatory submissions. Review and approve project documents, investigate deviations, implement CAPAs, and author Change Controls. Actively participates in customer audits as a subject matter expert (SME) for current Good Manufacturing Practices (cGMPs) and site SOPs.
Utilizes Practical Process Improvement (PPI) tools to improve efficiencies and overcome obstacles to execution, delivering outstanding customer performance while aligning with corporate Quality and EH&S standards.
Keys to Success:
Education
- B.S. Pharmaceutical Sciences or a related scientific or engineering field preferred.
Experience
- 8+ years of experience in the pharmaceutical industry, preferably in oral solid dosage form development, and 5+ years of leadership experience in a people management role (equivalent combinations of education, training, and meaningful work experience may be considered).
Knowledge, Skills, Abilities
- Ability to drive functional, technical and operational excellence.
- Proven track record to inspire innovation, collaboration, clarity and team effectiveness.
- Thorough understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and pharmaceutical regulatory compliance.
- Proficient in written and verbal communication and delivering presentations.
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!