Principle Associate/Scientist (Analytical Chemistry)

Job description

The Position

Primary Purpose of Job (Job Summary)

Provide technical expert to support the process development and formulation development in CMC setting; Play key roles in coordinating analytics related activities cross functions, between global and local, as well as with external partners.

Principal Roles & Responsibilities / Accountabilities
(Major functions of the position)   

-- Represent the analytics at cross-functional project teams. Lead analytical activates to support programs from late phase discovery to early clinical development.

-- Perform analytical method development (such as assay/impurity, chiral purity, etc.), release testing, impurity identification to support API process development.

-- Evaluating the physiochemical properties of API and DP such as particle size, dissolution, content uniformity, etc. to support solid oral drug product.

-- Specifications setting for both API and drug product with justifications

-- Author analytical related documents including test protocol, method validation protocol/report, method transfer protocol, stability protocol/report and release CoA, etc.  

-- Manage collaborations with CRO/CMO for outsourcing activities. Oversee analytical method development, validation, release testing, and stability study carried out at CRO/CMO.

-- Prepare the analytical sections of documents for DS/ DP to support regulatory filings.

Education/Qualifications

Ph.D. degree in analytical chemistry or closely related field with >2 years’ working experience in pharmaceutical industry, or Master degree in analytical chemistry or closely related field with at least 5-10 years’ working experience in pharmaceutical industry.

Leadership Competencies

Technical Expertise, Decision Making, Interacting and collaborate efficiently with cross function team, Independent problem solving skill.

Job Required Competencies

Solid knowledge on the state-of-the-art analytical theories and technologies, and hands-on experience in operating, calibrating, maintaining and troubleshooting of a wide range of analytical instruments (HPLC, GC, SFC, IC, LCMS, dissolution, etc.).

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

Hands-on experience in dissolution method development and IVIVC modeling to support solid oral drug products is a plus

Familiar with ICH guidelines and good understanding of cGMP & GLP lab operation

Excellent written and communication skills in English and being able to work effectively with a diverse team of co-workers in a dynamic environment.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.