
Senior Pharmaceutical Manufacturing Specialist
2 weeks ago
The Pharmaceutical Manufacturing Specialist plays a pivotal role in ensuring the seamless start-up of new manufacturing processes. Reporting directly to the Ramp Team Sr. Director, this individual will be part of a cross-functional team responsible for supporting multiple new API/Dry Products sites across various locations.
This dynamic position requires strong technical expertise in manufacturing science, process understanding, and documentation requirements. As a key member of the ADN RAMP team, you will collaborate closely with operations, process engineering, QCL, and other process team members to ensure effective process execution and troubleshooting.
Key Responsibilities:
- Support site start-up through documentation preparation and review
- Maintain process control and stability throughout the campaign
- Conduct root cause analysis to investigate process issues and implement corrective actions
- Develop and maintain comprehensive documentation, including electronic batch records and process flow documents
- Collaborate with the Molecule Steward to ensure accurate and up-to-date TSMS documentation
- Engage with stakeholders to provide training and coaching on quality management systems and technical writing
Requirements:
- Bachelor's degree in Chemistry, Biochemistry, or related field with 3-5 years' experience in pharmaceutical manufacturing or MSc with 3+ years' experience in pharmaceutical drug substance manufacturing support
- Strong analytical and problem-solving skills, excellent verbal and written communication skills, and ability to influence without authority
- Collaborative mindset, willingness to work off-shift hours, and adaptability to changing priorities
Benefits:
- Opportunity to work on cutting-edge projects, leveraging technical expertise to drive business growth
- Challenging role that fosters professional development, leadership skills, and continuous learning
- Diverse and inclusive work environment with opportunities for networking and career advancement
Join Our Team:
We're looking for highly motivated individuals who share our passion for innovative manufacturing solutions. If you're passionate about driving excellence in pharmaceutical manufacturing, we encourage you to apply for this exciting opportunity.
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