Scientist/Sr. Scientist, CMC Analytical Development
2 days ago
Arrowhead Pharmaceuticals is seeking a highly skilled Scientist/Sr. Scientist to join our Analytical Development team within the CMC Manufacturing Organization. As a key member of our team, you will play a critical role in supporting method development and validation activities for new drug substances and drug products.
Key Responsibilities- Develop and validate analytical methods for drug substance and drug product development, ensuring compliance with cGMP policies and procedures.
- Support testing required for drug substance and drug product process development, characterization of impurities, and other activities associated with GLP Toxicology and cGMP Clinical Trial materials.
- Provide technical guidance and development to junior scientists, ensuring the successful execution of analytical projects.
- Collaborate with cross-functional teams to ensure project deliverables are met, and analytical requirements are met, including scheduling, prioritizing, and coordinating analytical testing.
- Design and execute non-routine experiments, analyze and interpret data/results, and propose appropriate follow-up.
- Prepare technical reports, presentations, SOPs, and policies and procedures, ensuring high-quality documentation.
- Develop specifications and test methods for raw materials, in-process and isolated intermediates, as well as drug products.
- Calibrate, maintain, and troubleshoot all analytical equipment, ensuring optimal performance.
- May perform release testing of raw materials, stability study samples, method validation, and method transfer activities for toxicology and clinical trial activities when needed.
- Ph.D. in Chemistry (or related field) with 0-5 years of relevant experience, M.S. in Chemistry (or related field) with at least 10 years of relevant experience, or B.S in Chemistry (or related field) with at least 14 years of relevant experience.
- Expertise in method development and validations in support of drug substance and drug product development, and manufacture.
- Skills and knowledge in handling, analyzing, and characterizing chemicals, pharmaceuticals, and related organic molecules.
- Expertise with analytical instrumentation, and test methodology/validations.
- Knowledgeable with data acquisition systems, and cGMP policies and practices.
- Demonstrated experience with analytical instrumentation theory and practice as well as pharmaceutical drug substance and drug product development and processes.
- Has a solid understanding of CMC regulatory requirements for pharmaceutical products.
- Knowledgeable of cGMP, ICH, CDER requirements.
- Understanding of basic theories and principles of synthetic organic chemistry.
- Strong attention to detail.
- Can perform tasks assigned with minimal supervision.
- Works well with others and in a team environment.
- Can be flexible with changing priorities.
Arrowhead Pharmaceuticals provides competitive salaries and an excellent benefit package. We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced Scientist/Sr. Scientist looking to join a dynamic team, please submit your application.
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