Analytica R&D Scientist

SUMMARY OF POSITION

The Scientist is responsible to perform the following tasks independently.

• Functions as the key method development analyst utilizing orthogonal analytical equipment such as HPLC, GC, SEM and XRPD, etc.
• Provides analytical support for internal and external product development projects, including but not limited to routine sample analysis and stability testing.
• Performs method validation independently, including protocol and report writing and reviewing.
• Supports the method transfer to internal GMP manufacturing site (NPI) or to external GMP manufacturing sites (CMO).
• Be the focal SME to review analytical developmental documents for both the API and finished products of third-party external development and manufacturing projects and providing comments/ edits.
• Identifies critical method attributes. Identifies, develops, and justifies methodology and specifications supporting API and finished products under development.

ORGANIZATION STRUCTURE

The Analytical R&D Scientist reports to the Research Fellow/Principal Scientist, Analytical R&D.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

• Performs various analytical testing for API, raw materials, in-process and finished products to support internal or external development projects.

• Prioritizes activities to provide timely analytical support to product development. Anticipates analytical issues early in the R&D development process and provides long term planning for analytical method development and improvement.
• Independently performs unknown impurity identification study and material characterization study.
• Performs quantitative and qualitative LC-MS/GC-MS analysis, and IVIVR dissolution method development.
• Reviews data, design and execution of experiments, and interprets results to define solutions, identify new methods to enhance the analytical capacity.
• Demonstrates comprehensive understanding and use of scientific principles and professional practices to solve a wide range of complex problems in creative and practical ways.
• Delivers and communicates accurate results to project teams, provides intellectual input, and contributes to decision making.
• Experience on various method development for large molecule drugs, including related compound methods, is a plus.

QUALIFICATIONS

• PhD, MS or BS in Chemistry, Biochemistry or related discipline with 4+ years (PhD) or 7+ years (MS), or 10+ years (BS) of experience in pharmaceutical industry or CROs.
• Experience in analytical techniques including UV-Vis, RI, Fluorescence detection, HPLC, SEC, LC-MS, CE, CD spectroscopy, GC-MS, NMR, KF, FTIR, DSC etc. and advanced analytical technique.
• Must have recent working experience in analytical method development for large molecules including peptides.
• Good understanding of regulatory requirements: ICH, USP/EP/JP etc.
• Ability to work independently and manage projects in a timely manner.
• Understanding of cGXP requirements preferred.
• Strong organization, communication and interpersonal skills.

GMP DECISION-MAKING AUTHORITY

Responsible for decisions related to:

• When laboratory management must be notified to determine whether an investigation is warranted.
• Whether they have been trained to perform a GMP task.
• Suitability of analytical equipment/instruments for use.

We are an EEO Employer, including disability & vets.