Chemist III ‑ Analytical Services
Genus Lifesciences™ is a specialty pharmaceutical company engaged in the development and commercialization of generic and branded pharmaceutical products. Founded in 1999, Genus Lifesciences™ employs over one hundred fifty professionals in all phases of pharmaceutical operations, and its products are available in pharmacies and other retail outlets throughout the United States. In addition to its local presence, Genus Lifesciences™ has on-going research efforts through global partnerships related to its technology platforms.
Position: Chemist III – Analytical Services
Reports to: Group Leader, Analytical Services
Responsibilities:
- Independently perform analytical testing of raw materials, in-process materials, stability samples, finished products as per the test method, SOPs or USP Compendia procedures
- Perform complex chemistry testing like Related Substances / Impurities and Residual Solvents. Other analytical testing will include Assay, preservative content, LOD, ROI, water content, identification test, dissolution, disintegration, heavy metals etc.
- Operates general analytical instruments during routine testing including but not limited to HPLC, GC, KF /Automatic titrator, FT-IR, Polarimeter, UV/Vis spectrophotometer, melting point apparatus, dissolution and disintegration units, Malvern Particle size analyzer, and laboratory ovens
- Prepare and review technical documentation including test method, SOPs, analytical reports and change controls
- Independently solve technical problems within the scope of the assignment
- Performs peer review of laboratory data
- Performs assigned workload on a daily basis and effectively completes multiple assignments
- Author laboratory deviations and laboratory investigation reports and assists laboratory personnel with the execution of laboratory test that are required for the investigation
- Assist less experienced chemists to solve routine analytical problems and provide required training
- Contributes to a cohesive team environment and maintains a positive attitude. Plans individual workload in coordination with team members
- Maintains a clean and safe laboratory work environment
- Recognizes deviations from normal trend and inform group leader or laboratory management of any problems and/or deviations that may affect the integrity of the data and participates in corrective action of problems
- Complies with all current Good Manufacturing Practices (cGMP) current Good Laboratory Practices (cGLP) and Environmental Health & Safety (EHS) requirements, laboratory Standard Operating Procedures (SOPs) and company policies and procedures
- Compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances
- Supports systems to ensure the successful completion of Departmental goals and objectives
- Communicate with department leads of QA, Product Development and Manufacturing for assistance and closeout of work activities
- Performs other related duties as assigned
Requirements:
- Bachelor / Master’s Degree in Chemistry, Pharmaceutical or other scientific discipline with 5+ years’ experience in a pharmaceutical lab
- Must have good verbal and written communications skills
- Experience with Empower chromatography data acquisition software and other laboratory software is preferred
- A strong demonstrated belief in continuous improvement
- General computer skills – word processing, spreadsheet, database and statistical analysis
- Proven concern with working in a safe and environmentally correct manner
- Ability to solve complex technical problems using chemical tests requiring extensive experience in the application of procedures
Physical Requirements:
- This position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance and lift up to 50 pounds.
- Requires use of Company approved PAPR as necessary