Bachelor's Degree in Chemistry or equivalent experience
Minimum of 2 years' experience in a pharmaceutical environment with small molecules
Proficient in developing and validating analytical methods using HPLC or GC
Hands-on experience with Empower software
Experience in preparing CMC documents for ANDA filings is a plus
Strong documentation skills according to cGMP standards
Ability to work independently and take initiative under minimal supervision
Responsibilities
Support analytical method development and validation for drug product development
Conduct improvements and modifications on commercial and new product analytical methods
Troubleshoot analytical methods and instruments for raw materials and products
Maintain good documentation practices for lab work, stability studies, and protocol-driven R&D studies
Operate a variety of analytical instrumentation like HPLC, GC, and FTIR
Analyze chemical and physical properties of organic and inorganic compounds
Assist with method feasibility studies and validation processes
Benefits
Collaborative team environment
Opportunities for professional development and training
Involvement in impactful drug product development
Access to advanced analytical instrumentation
Potential for career growth within the pharmaceutical industry
Full Job Description
PRIMARY DUTIES AND RESPONSIBILITIES:
Support analytical method development, validation, and transfer for drug product development including formulation development, stability tests, and release tests.
Validate/verify new or existing USP methods, write and review method validation/verification protocols, reports, analytical method, and SOPs.
Conduct method improvements and modifications on commercial or new product analytical methods for drug substance and product for continued improvements.
Trouble-shoot problems of instrument or analytical methods for raw materials, finished product.
Good documentation practice for lab notebook, logbook, validation and verification report, stability studies, lot release testing, and protocol driven R&D studies.
Conduct method development and USP method feasibility studies for assay, trace minerals, and associated characteristics for drug products
ASSOCIATED DUTIES AND RESPONSIBILITIES:
Operate HPLC, GC, ICP, UV, FTIR, dissolution, Malvern Particle Analysis, XRD, and other analytical instrumentation.
Analyze organic and inorganic compounds to determine chemical and physical properties.
Method development, validation or verification, and method transfer.
Other related duties as assigned by lab Director.
REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS:
Bachelor's Degree (B.S.) or higher in Chemistry, with two or more years of related experience and/or training; or equivalent combination of education and experience.
Worked in a Pharmaceutical company (4 years or more) on small molecules with good documentation practice/cGMP.
Developed and validated analytical methods using HPLC, or GC, for assay, impurity, residual solvents, and dissolution. Hands on experience using Empower software.
Experience in supporting CMC documents for ANDA filing is preferred.
Work well in a team environment with good communication both verbal and written English language for clear and accurate documentation of results and communicate for project update.
Mastery in calculations with good lab records for lab notebooks, logbooks, and laboratory reports according to good documentation practice for cGMP compliance.
Ability to understand cGMP principles and FDA regulations for drug product development.
A self-starter, working under limited supervision, and capable of taking initiative in prioritization and implementation of work.
Ability to read and interpret scientific articles and documents, such as method development publications, FDA regulations, safety rules, and procedure manuals.
Ability to apply mathematical operations to tasks as determination of test reliability and validity, analysis of variance or RSD, correlation coefficient with linear regression, as well as difference (f1) and similarity factor (f2).
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.
Experience with FDA audit for cGMP compliance is desirable.
