CMC Project Manager
Celebration, FL
Department: Manufacturing
Reports To: Head of Manufacturing
Reporting Employees: none
Position Summary:
The primary purpose of the CMC Project Manager position is to manage and coordinate Chemistry, Manufacturing, and Controls (CMC) activities throughout the various KemPharm CMC programs.
Essential functions:
The primary purpose of the CMC Project Manager position is to manage and coordinate Chemistry, Manufacturing, and Controls (CMC) activities throughout the various KemPharm CMC programs.
- Communicate within the internal CMC team and manage the various CMC activities involved in respective commercial and development programs.
- Maintain CMC documentation (protocols, data reports, manufacturing batch records, standard operating procedure, CMC regulatory filings, etc.) to meet quality requirements withing the internal document management systems.
Competencies:
- Ability to be highly functional in a fast-paced dynamic company with the ability to prioritize issues and to work collaboratively with cross-functional teams.
- Ability to manage multiple projects
- Excellent communications skills and the ability to work with internal and external stakeholders and partners.
- Highly organized and strong attention to detail
- Independent worker who works effectively in a team environment
- Customer Orientation
Requirements:
- Bachelor’s or Master’s Degree in Science or related science field
- Five to seven years of experience in pharmaceutical, biotechnology, or academic environment managing activities related to CMC or manufacturing development and SOP/technical document writing
- Knowledgeable in various GMP processes, equipment, and cleaning
- Technical knowledge of manufacturing operations and understanding of batch record procedures and other documentation required for manufacturing execution
Other skills and abilities:
- Strong computer skills including fluency in:
- Microsoft Office 365
- Adobe Acrobat
- EndNote preferred
- eDMS applications
- eCTD software preferred, but not essential
- Experience with electronic document management software, eDMS deployment, administration, and management.
- Ability to prepare and maintain basic databases for monitoring files.
- Proficient in eDMS administration, electronic publishing, electronic content management and database management.
- Experience with varied document/records indexing structures, record retention requirements, scanning and high-volume printing.
- Strong knowledge of publishing standards to support regulatory authority submissions.
Careers Post Resume
Zevra Therapeutics is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.