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.
At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K.
All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.
