Scientist II DP Development
CMC / Technical Operations
Akebia is seeking a motivated and talented scientist to join the Drug Product Development team of the Pharmaceutical Development – CMC department. The Scientist II role will support drug product formulation and manufacturing process development for projects ranging from pre-clinical to late stage clinical development. The qualified candidate must have experience and/or knowledge in oral solid dose preformulation, formulation development and/or process development.
- Support formulation and process development activities at external laboratories
- Manage GMP production campaigns at contract development and manufacturing organizations
- Assist with the design and execution of pre-clinical and clinical formulation development studies for solid/liquid oral dosage products
- Author, review and data verify drug product technical development reports, manufacturing/packaging batch records and other development-related documents
- Participate in drug product-related regulatory filings and investigations
- Collaborate with CMC and partner function lines, including discovery, drug substance development, analytical development, technical operations, supply chain, project/program management, quality and regulatory to achieve project deliverables and timelines
- Travel and visit external sites to monitor and contribute to development activities
- BS 6+ years of experience, MS 3+ years of experience or PhD 1+ years of experience in pharmaceutical dosage form development
- Experience in phase-appropriate oral solid dose formulation development and manufacturing process development
- Experience in conducting and managing drug product activities at CDMOs
- Strong organizational, interpersonal, written and verbal communication skills
- Solid fundamental understanding of biopharmaceutical and physicochemical properties relevant to formulation design and development
- Candidate should be self-motivated, eager to contribute and willing to work collaboratively with team
Domestic and international travel (20-30%) is required for this position
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease. The company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com.
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.
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