- Take charge of process development tasks, including cell culture, fermentation, and protein purification
- Supervise both internal teams and external vendors
- Collaborate with various departments like CMC, Manufacturing, QA/QC, and Supply Chain
- Lead the preparation of key CMC sections for different submissions
- Manage a team of scientists working on upstream and downstream processes
- Hold an advanced degree in Pharmaceutical Sciences or a related field with at least a decade of industry experience
- Demonstrated experience in engaging with senior leadership across different functions
- Proven track record in overseeing external vendors and internal R&D projects
- Skilled in authoring submissions for regulatory approvals
- Familiarity with various modalities like mAbs, ADCs, fusion proteins, VLPs, and Vaccines
- Conduct Post Market Activities and Surveillance
- Handle Customer and Product Complaint Investigations
- At least 1 year of technical experience in medical device/pharma/biotech industry
- Minimum qualification of a Bachelor's degree
- Proficiency in computer skills
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Director/Sr. Director - Boston, United States - EPM Scientific
Description
Director/Sr. Director - Process Development
Highly Important Role in a Leading Pharmaceutical Company in Greater Boston Area
Excellent Compensation Package and Additional Bonuses/Benefits Included
Key Responsibilities:
Requirements:
About the Company:
A top-tier pharmaceutical company, renowned for its innovative COVID diagnostic tests, is on a hiring spree to onboard over 200 talented individuals. This presents a unique opportunity for Quality Specialists to join the team responsible for managing customer complaints and conducting thorough investigations.
Additional Job Responsibilities:
Education and Experience Requirements: