Scientist II, Analytical Process Science (Onsite)

Partner Therapeutics • WA

81d • $122,500 - $150,000

About The Position

The Analytical team in the Process Science Department is a group of scientists and subject-matter experts who specialize in the development of analytical test methods and analysis of commercial drug product and the raw materials used to manufacture drug substance and drug product. This position will help advance raw materials and drug substance projects through cross-functional collaborations with project teams in both non-GMP Process Science and GMP Quality Control laboratories.

Requirements

• Strong knowledge and experience with Analytical HPLC, FTIR, Gas Chromatography, and Atomic Absorption Spectroscopy.
• Knowledge of Industry Best Practices and testing methodologies for operation and maintenance of instrumentation used in raw materials testing.
• Experience with GMP regulatory standards and understanding of FDA expectations for analytical test methods.
• Ability to work independently to solve difficult technical questions.
• Maintains meticulous and accurate documentation of testing procedures, observations, and results.
• Strong written and oral communication skills with demonstrated ability to convey complex scientific and technical concepts.
• Strong critical thinking, analytical, and problem-solving skills.
• Resourceful with proven ability to lead, manage, and leverage an extensive internal network.
• Possesses strong organizational and prioritization skills.
• Excellent soft skills including a bias towards action and adaptability.
• Solid English language communication skills, both oral and written.
• Proficiency with MS Office products, especially Word and Excel.

Nice To Haves

• Knowledge and application of USP, ICH, FDA, PMDA, and EMA regulatory guidance.
• Experience with GC-MS, GC-FID, ICP-MS, and Ion Chromatography.
• Experience with Protein and Peptide mass spectrometry.

Responsibilities

• Serves as the subject matter expert for the raw materials testing program, ensuring compliance with global regulatory and pharmacopeial standards.
• Assists in audits and inspections of raw material analytical testing, investigating and troubleshooting analytical testing issues.
• Leads internal and external development teams, qualification and validation of analytical test methods and/or new instrumentation for raw materials, drug substance and drug product testing.
• Leads work performed at contract testing laboratories, including identification and qualification of vendors and technical review of work performed.
• Designs and conducts experiments supporting manufacturing, process development, regulatory requests, and cross-functional investigations.
• Authors and reviews specifications, protocols, SOPs, technical reports, and test methods to approve raw materials for use in production.
• Provides scientific, technical, and functional knowledge of analytical and raw materials methodologies to assist working teams.
• Resolves issues by ensuring timely escalation to Leadership and cross-functional teams.
• Keeps abreast of current industry trends, compliance requirements, and best-of-class technologies.
• Pursues participation or leads project teams outside normal course of work to support personal growth.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, and company policies.
• Successfully completes all mandatory Quality and Compliance training within required time frames.

Benefits

• Medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage.
• Pre-IPO options, cash bonuses, 401k matching.
• Free parking or Seattle-area ORCA pass.
• Tuition/educational assistance.
• Rewards for achievement and contribution.
• Gym subsidy and wellness participation programs.
• Generous vacation, sick, and holiday paid time off program.
• Paid shutdown between the Christmas and New Year’s holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees