Akebia is seeking a motivated and talented scientist to join the Process Research & Development group in the Tech. Ops. of the CMC department. The Senior Scientist will be responsible for process research and development including manufacture of drug substance material, process definition, process development and process scale up. Experience providing oversight of research and manufacturing outsourced to third party vendors is preferred
Required Skills
Manages drug substance development and manufacturing activities (Phase 1 – 3) at external laboratories and contract manufacturing facilities for small molecule drug substances
Collaborates with Project (cross-functional) and CMC teams to monitor development plans
Collaborate with CMC and partner function lines, including discovery, process development, analytical development, quality and regulatory to achieve project deliverables and timelines
Coordinates with project team to implement plans for timely delivery of clinical materials.
Participates in the selection and management of contract manufacturing organizations (CMOs)
Conducts phase appropriate process development and manages drug substance campaigns at external CMOs
Provides scientific guidance to CMO’s and helps trouble-shooting development and production issues
Participates in the development and revision of in process tests and product specifications
Reviews documentations from external CMOs
Participates in review drug substance-related sections for regulatory filings
Independently writes technical development reports
Reviews batch records
Required Experience
OR
MS in organic chemistry, or related scientific discipline with 8+ years of experience working in pharmaceutical drug development
3+ years of drug substance development experience
Proven track record in developing and implementing robust and efficient drug substance manufacturing processes
Demonstrated knowledge of regulatory requirements for drug substance submissions
Strong communication, presentation, and writing skills
Ability to plan, organize and manage multiple projects simultaneously
Strong ability to exercise independent judgment
Ability to work cross-functionally and in virtual teams
Demonstrated ability to effectively manage outsourced GMP manufacturing
TRAVEL REQUIREMENTS:
Willingness to travel to various meetings or vendor sites, including overnight trips. Some international travel may be required (up to 10%)
Akebia Therapeutics is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
Manages drug substance development and manufacturing activities (Phase 1 – 3) at external laboratories and contract manufacturing facilities for small molecule drug substances
Collaborates with Project (cross-functional) and CMC teams to monitor development plans
Collaborate with CMC and partner function lines, including discovery, process development, analytical development, quality and regulatory to achieve project deliverables and timelines
Coordinates with project team to implement plans for timely delivery of clinical materials.
Participates in the selection and management of contract manufacturing organizations (CMOs)
Conducts phase appropriate process development and manages drug substance campaigns at external CMOs
Provides scientific guidance to CMO’s and helps trouble-shooting development and production issues
Participates in the development and revision of in process tests and product specifications
Reviews documentations from external CMOs
Participates in review drug substance-related sections for regulatory filings
Independently writes technical development reports
Reviews batch records