Senior Scientist, Analytical Process Science (Onsite) at Partner Therapeutics

, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jan, 26

Salary

170000.0

Posted On

07 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

HPLC, FTIR, GC-MS, GC-FID, ICP-MS, Atomic Absorption Spectroscopy, Ion-Chromatography, GMP, FDA Regulatory Standards, Analytical Test Methods, Documentation, Communication, Raw Materials, Biologics, Mass Spectrometry

Industry

Biotechnology Research

Description

SENIOR SCIENTIST, ANALYTICAL PROCESS SCIENCE (Onsite) POSITION SUMMARY 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 lead raw materials projects and help advance drug substance projects through cross-functional collaborations with project teams in both non-GMP Process Science and GMP Quality Control laboratories. PRIMARY RESPONSIBILITIES Serves as the subject matter expert for the raw materials testing program. This will include ensuring compliance of raw material testing programs with global regulatory and pharmacopeial standards, assisting in audits and inspections of raw material analytical testing, investigating and troubleshooting analytical testing issues and investigations. Oversees internal and external development, qualification and validation of analytical test methods and/or new instrumentation for raw materials, drug substance and drug product testing in alignment with regulatory guidelines. Oversees work performed at contract testing laboratories, including identification and qualification of vendors, technical review of work performed, and ensuring vendor follow-through on commitments. Designs and conducts experiments supporting manufacturing, process development, regulatory requests, and cross-functional investigations relating to raw materials quality and release. 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 and best practices to assist working teams in Quality Control, Analytical Lifecycle Management, and Process Science. KNOWLEDGE, SKILLS, ABILITIES Required: Strong knowledge and experience with HPLC, FTIR, GC-MS, GC-FID, ICP-MS, Atomic Absorption Spectroscopy, and Ion-Chromatography. Knowledge of Industry Best Practices and testing methodologies for operation and maintenance of instrumentation used in raw materials testing. Knowledge and experience with GMP and FDA regulatory standards for Analytical Test Methods. 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 through presentations and publications. Preferred: Knowledge and application of USP, ICH, FDA, PMDA, and EMA regulatory guidance strongly preferred Experience with both Raw Materials and Biologics test methods Experience with mass spectrometry EXPERIENCE & EDUCATION Required: PhD in Analytical Chemistry, Medicinal Chemistry, Biochemistry, or Bioengineering with 5+ years; MS with 10+ years; or BS with +15 years of relevant industry experience. Experience working in a cGMP Manufacturing Facility/environment or other highly regulated environment. PTx is committed to the principles of pay equity and providing competitive compensation for all of our Partners. The current pay range for this position is $144,000 – $170,000. Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience. All Partners are offered medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage. We offer a terrific compensation/benefits/perks package which includes pre-IPO options, cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition/educational assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays (dependent on business conditions.) Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state, or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.

Responsibilities

Lead raw materials projects and advance drug substance projects through collaboration with cross-functional teams. Oversee the development, qualification, and validation of analytical test methods and ensure compliance with regulatory standards.