Partner Therapeutics

SCIENTIST II, 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 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.

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.  
• 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 in alignment with regulatory guidelines.
• Leads 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. 
• Resolves “stuck” issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Pursues participation or leads project teams outside normal course of work (i.e. “collateral duties”) as they become available to support personal growth, connection, and business needs.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required time frames.

KNOWLEDGE, SKILLS, ABILITIES
Required:

• 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 used in raw material and product release.
• 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 through presentations and publications.
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
• Resourceful with proven ability to lead, manage, and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues. Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges.
• Solid English language communication skills, both oral and written, are required for this highly collaborative role. Willingness and ability to clearly express opinions and ask questions.  Comfortable actively participating in cross-functional meetings.
• Proficiency with MS Office products, especially Word and Excel are essential; ability and willingness to quickly adopt other job-specific applications will be necessary.

Preferred:

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

EXPERIENCE & EDUCATION
Required:

• PhD in Chemistry, Medicinal Chemistry, Biochemistry, or Bioengineering with 2+ years; MS with 8+ years; or BS with +13 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 $122,500 – $150,000. 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.