The Scientist II, Analytical Sciences will support the analytical commercial portfolio including method lifecycle management and transfers for small molecule drug substances and products. Knowledge of a broad range of analytical techniques commonly used in the analysis of pharmaceuticals is required.
Required Skills
- Provide analytical oversight of external vendors for commercial CMC activities for small molecule drug substance (DS) and product (DP).
- Provide oversight and direction for phase appropriate development, validation and transfer of analytical methods for DS and DP at CMOs. Note that all analytical tasks are outsourced (no internal lab functions).
- Excellent problem-solving skills are required.
- Participate in the development and revision of product specifications, provide scientific input and critique analytical results.
- Participate in the preparation of CMC sections of regulatory submissions along with other functional groups.
- Ensure compliance with analytical requirements for CMC regulatory submissions.
- Familiarity with a broad range of analytical techniques for characterization of pharmaceuticals including HPLC & GC with a variety of detection methods, wet chemical analysis (e.g., KF, dissolution, etc.), spectroscopic techniques, particle size, and heavy metal analysis.
- Understand the drug development process, and their impact on analytical method development, validation strategies and specifications.
- Participate in analytical investigations for deviations/OOSs/OOTs and ensure proper corrective and preventive actions (CAPAs) are taken.
- Performs other duties as assigned.
Required Experience
BASIC QUALIFICATIONS:
Bachelors degree
PREFERRED QUALIFICATIONS:
- Master’s degree or PhD in Chemistry
- Minimum 8 years (with BS), 4 years (with MS) or 2 years (with PhD) of experience in an Analytical Chemistry or QC group
- Strong analytical, communication, presentation, and writing skills
- Ability to manage priorities and maintain timelines in a fast-paced environment
- Ability to exercise independent judgment with minimal supervision
- Ability to work cross-functionally
- Demonstrated ability to effectively manage outsourced analytical activities
- Regulatory experience is a plus
- No relocation for this position
- Remote or hybrid work style possible
- TRAVEL REQUIREMENTS: Up to 15% travel may be required to participate in vendor meetings and/or observe testing first-hand
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by 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 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.