Scientist / Sr. Scientist, CMC Analytical Development

ZipRecruiter; Verona; In loco; EUR 110.000 - 130.000; Tempo pieno

Descrizione del lavoro

A leading biopharmaceutical company is seeking a Senior AD Scientist to enhance method development in its Analytical Development group. The successful candidate will engage in critical tasks related to drug substances, lead projects, and collaborate across teams while applying scientific principles for problem-solving. A Ph.D. or equivalent experience in Chemistry, with a commitment to quality and detail, is essential for this role, alongside a passion for innovation in healthcare.

Competenze

• Ph.D. in Chemistry or related field is preferred.
• Expertise in method development and validation.
• Proficiency with analytical methodologies is required.

Mansioni

• Lead and mentor junior scientists.
• Develop specifications and test methods for materials.
• Analyze data and write complex project documentation.

Conoscenze

Attention to detail

Teamwork

Adaptability

Formazione

Ph.D. in Chemistry or related field

M.S. with at least 10 years experience

B.S. with at least 14 years relevant experience

Strumenti

Analytical instrumentation

Descrizione del lavoro

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical-stage biopharmaceutical company that develops medicines to treat intractable diseases by silencing disease-causing genes. Using a broad portfolio of RNA chemistries and efficient delivery modes, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable gene knockdown. RNA interference, or RNAi, is a natural cellular mechanism that inhibits the expression of specific genes, affecting protein production. Arrowhead's RNAi-based therapeutics leverage this pathway to address diseases.

Arrowhead focuses on developing innovative drugs for genetically based diseases, often characterized by overproduction of proteins involved in the disease. The company's versatile RNAi technologies enable potential treatment across various therapeutic areas, including targets outside the liver, such as lung diseases. The pipeline includes clinical and preclinical candidates.

Headquartered in Pasadena, CA, with R&D teams in Madison, WI, and San Diego, CA, Arrowhead's team comprises science-driven innovators committed to bringing new therapies to patients.

The Position

This role is part of the Analytical Development (AD) group within the CMC Manufacturing organization. The Senior AD Scientist will support method development and validation activities for new drug substances and products. Responsibilities include testing for process development, impurity characterization, and activities related to GLP toxicology and cGMP clinical trial materials. The role reports to AD management.

Responsibilities

• Adhere to Arrowhead Core Values, cGMP policies, SOPs
• Provide accurate analytical results supporting projects
• Work independently and with teams to meet project timelines
• Lead and mentor junior scientists
• Coordinate analytical testing as Analytical Project Lead
• Prepare technical reports, SOPs, and policies
• Design and improve analytical methods for API and drug development
• Apply scientific principles to solve analytical problems
• Develop specifications and test methods for materials and products
• Design and execute experiments
• Analyze data and propose follow-up actions
• Write complex project documentation
• Collaborate across groups to meet deliverables
• Perform peer reviews and draft deviations/out-of-specification reports
• Perform testing for API and drug development samples
• Maintain and troubleshoot analytical equipment
• Support release testing, validation, and transfer activities as needed
• Perform other duties as assigned

Requirements

• Ph.D. in Chemistry or related field with 0-5 years of experience, M.S. with at least 10 years, or B.S. with at least 14 years of relevant experience
• Expertise in method development and validation for drug substances and products
• Proficiency with analytical instrumentation and methodologies
• Knowledge of data systems, cGMP policies, and pharmaceutical regulations
• Understanding of organic chemistry principles
• Strong attention to detail, independence, teamwork, and adaptability

Salary range in Wisconsin: $110,000—$130,000 USD. Arrowhead offers competitive salaries and benefits. Applicants must have authorization to work in the US.

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