Sr Scientist II (Analytical Development, Drug Product)

SUMMARY/JOB PURPOSE:The Sr. Scientist II is responsible for laboratory support to the clinical development of small molecule anti-cancer drugs with emphases on development of drug products. The incumbent is expected to have in-depth understanding and extensive hands-on experience in DP method development, especially assay/degradation products, dissolution and solid-state characterizations. Responsibilities include, but are not limited to, internal method development, method troubleshooting, OOT/OOS investigations, oversight of method transfer to CDMO, analytical data review for release and stability, reference standard certifications, support to regulatory filings, etc.ESSENTIAL DUTIES AND RESPONSIBILITIES:Work closely with pre-formulation team and formulation team, and provide timely analytical support to pre-formulation, formulation development, and drug product manufacturing.Design, plan and execute experiments independently to develop DP methods, especially those critical ones, such as assay/degradation products and dissolution, in-house, and then transfer to internal partners or CDMO.Perform essential laboratory activities to troubleshoot technical issues of drug products from internal and external customers, and to support OOS or OOT investigations; Coordinate and monitor specific method development activities or studies within a larger project.Provide analytical support to physicochemical and solid-state characterization of drug products.Process, interpret and summarize experimental data, and present the data internally and to senior management.Perform technical review of method validation data, release and stability data (including raw test data) to ensure compliance with all established and approved analytical procedures and regulations.Develop subject matter expertise (SME) in certain analytical techniques, such as solid-state techniques, and act as a resource for other employees within the department.Author reports, protocols, test methods, regulatory filing sections, and other documentations.Maintain lab instrumentations and train junior scientists.SUPERVISORY RESPONSIBILITIES:Not requiredEDUCATION/EXPERIENCE/SKILLS:Education:PhD degree in Analytical Chemistry or related Sciences and a minimum of 2 years of related experience; or,Equivalent combination of education and experience.Experience:Hands-on experience and in-depth knowledge in method development for drug products, such as assay/impurities/degradation products method, dissolution method, content uniformity, KF, LCMS.Proficiency and problem-solving skills in HPLC/UPLC, dissolution, CU, KF, microbiological emulation test, mass spectroscopy (QQQ or QDa), and other analytical techniques.Experience in XRPD, PSD, DSC, DVS, TGA, IR, Raman, NMR (1H and solid state), and other physicochemical techniques is highly desired.Hands-on experience in reviewing raw data, protocols, reports, and documents generated in an analytical test laboratory is a must.Hands-on laboratory experience in small molecules and solid oral dosage development is preferred.Good investigative skills and ability to troubleshoot methods, OOT/OOS and other investigations.Hands-on experience and in-depth knowledge with instrumentation software such as Empower, MassLynx, ChemStation, JMP, etc.Knowledge/Skills/Abilities:Proven ability to design and execute experimental plans independently to tackle scientifically challenging problems.Demonstrated ability to manage multiple assignments and effectively complete all expected deliverables in a timely manner.Extensive knowledge of analytical development for varying stages of clinical development from pre-clinical to NDA, such as method development, method validation, release testing, stability testing, analytical support to tech transfer & process validation, phase-appropriate specifications, etc.Critical thinker with demonstrated ability to take initiative and work independently.Team player with capability to work within a team and as an individual contributor in a fast-paced environment.In-depth knowledge of Good Manufacturing Practices (GMP) and FDA/ICH and EU regulations and guidelines.Experience in regulatory filings, such as IND, IMPD and NDA.Ability to communicate clearly and effectively, both verbally and in writing.Detail oriented, data-driven, and self-motivated.WORKING CONDITIONS:Environment: primarily working in laboratories.Travel may not be required.DISCLAIMER:The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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