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 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 acts 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 required

EDUCATION/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-motiva