Principal Scientist in CMC Analytics

6 days ago

Shanghai, Shanghai, China Roche Full time

Position Overview

Key Responsibilities

The role involves providing expert technical support for the development of processes and formulations within a CMC environment. This position is crucial for coordinating analytical activities across various functions, both globally and locally, as well as collaborating with external partners.

Major Duties Include:

-- Act as the analytical representative in cross-functional project teams, leading analytical efforts to support programs from late-phase discovery through early clinical development.

-- Conduct analytical method development, including assay and impurity testing, as well as release testing and impurity identification to facilitate API process development.

-- Assess the physicochemical characteristics of Active Pharmaceutical Ingredients (API) and Drug Products (DP), such as particle size, dissolution rates, and content uniformity, to support solid oral drug product development.

-- Establish specifications for both API and drug products, providing justifications for these standards.

-- Prepare analytical documentation, including test protocols, method validation reports, method transfer protocols, stability reports, and Certificates of Analysis (CoA).

-- Oversee collaborations with Contract Research Organizations (CRO) and Contract Manufacturing Organizations (CMO) for outsourced activities, ensuring the development, validation, and testing of analytical methods, as well as stability studies.

-- Contribute to the analytical sections of regulatory documents for Drug Substances and Drug Products.

Qualifications

A degree in analytical chemistry or a closely related discipline, with over 2 years of experience in the pharmaceutical industry, or a Master’s degree with 5-10 years of relevant experience.

Leadership Skills

Demonstrated technical expertise, effective decision-making abilities, and strong collaboration skills with cross-functional teams. Ability to solve problems independently.

Required Skills

Comprehensive knowledge of contemporary analytical theories and technologies, along with practical experience in operating, calibrating, maintaining, and troubleshooting a variety of analytical instruments (e.g., HPLC, GC, SFC, IC, LCMS, dissolution).

Proficiency in analytical testing method development, validation, stability studies, and impurity identification to support both drug substance and drug product development.

Additional Experience

Experience in dissolution method development and in vitro-in vivo correlation (IVIVC) modeling for solid oral drug products is advantageous.

Familiarity with ICH guidelines and a solid understanding of cGMP and GLP laboratory operations are essential.

Excellent written and verbal communication skills in English, with the ability to work effectively within a diverse team in a dynamic environment.

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