- Carries out responsibilities in compliance with all cGMP, FDA, DEA, and OSHA regulations, as well as all applicable company compliance guidelines, policies, standards and objectives.
- Sets up and operates analytical instruments including (but not limited to) HPLC, GC, UV/Vis, Automatic titration, IR, AA, TLC and dissolution apparatus to support sample testing.
- Performs laboratory analyses of raw materials, in process (IP), finished products (FP) and stability (ST) samples. Prepares standard and sample solutions as required by the test methods.
- Performs wet chemistry tests such as LOD, pH, and titration.
- Performs physical tests including thermal analysis, particle size, viscosity, and density measurements.
- Performs all necessary calculations associated with test analyses.
- Labels, transcribes and records all testing details and results in laboratory notebooks and report sheets, compliant with GDP, cGMP and SOPs.
- Cleans, maintains and calibrates laboratory instruments to ensure compliance with cGLP and cGMP.
- Creates MV SOPs as needed.
- Prepares method validation/verification protocols and reports.
- Performs qualitative and quantitative analysis to support reference standard qualifications, method validation, method comparisons and transfers.
- Performs investigations, evaluates and verifies compendial methods.
- Tracks and maintains sample flow.
- Cleans and organizes MV lab areas.
- Performs related duties as assigned.
Requirements
Minimum Qualifications: Bachelor's Degree in Chemistry or related scientific field, with at least five (5+) years, or Master's Degree in Chemistry or related scientific field, with at least three (3+) years of experience in analytical development and/or method validation in the pharmaceutical field.Required Knowledge, Skills and Experience:
- Understanding of spectroscopic and chromatographic techniques and concepts.
- Hands-on experience in setting up and operating UV/IR, HPLC, GC, TLC and dissolution apparatus
- Working knowledge of FDA and cGMPs regulations and guidances as well as DEA and OSHA requirements.
- Knowledge of method validation parameters and their relevance in method performance.
- Strong understanding of QA/QC systems, including change control systems.
- Ability to perform analytical testing, calculations and data analysis as instructed.
- Ability to perform wet chemistry and physical testings as instructed.
- Ability to work collaboratively, as required, in a fast-paced environment.
- Ability to abide by company policies, practices and procedures, including cGMP, GDP and SOP requirements
- Good verbal and written communication skills.
- Ability to operate computer systems and software applications, including Microsoft office. Special knowledge or skills needed and or licenses/certifications preferred
- Proficiency with Empower Software
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Method Validation Scientist II - Monmouth Junction, United States - Tris Pharma
Description
Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success.
Our Method Validation Department located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Method Validation Scientist II.
Summary:
Under supervision, performs laboratory analyses of raw materials, in process (IP), finished products (FP) and stability (ST) samples for pilot and submission batches, according to SOPs and cGMP procedures. Prepares method validation protocols/reports, and carries out method validation activities, including interim method validation, to meet project timelines. Supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations. Tracks and maintains sample flow. Required to adhere strictly to company policies and current industry standards.
Essential Job Functions:
