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QA R&D Chemist I
4 months ago
Tris Pharma, Inc. (www.trispharma.com) 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.
Located in Monmouth Junction, New Jersey, Tris has 2 immediate openings for QA R&D Analytical Chemists, I
SUMMARY:
The Quality Assurance (QA) Research and Development (R&D) Analytical Chemist supports Quality Control (QC) and Analytical R&D (AR&D) activities by initiating appropriate change controls and updating specifications to reflect changes in methods. Analytical support activities include, but are not limited to: method improvements, system equivalency, transfers, verifications, alternate source qualifications and authoring residual solvent, elemental impurity and nitrosamine risk assessments, as directed by R&D. The incumbent may also perform additional responsibilities including laboratory analyses of raw materials, in-process (IP) testing, finished products (FP), stability (ST) sample testing and analytical instrumentation maintenance and calibration.
ESSENTIAL FUNCTIONS
Carries out responsibilities in accordance with company policies, Standard Operating Procedures (SOPs) and state, federal and local laws Creates, reviews or revises SOPs, methods, specifications, verification protocols, reports and change control requests, as needed; Performs vendor qualification for raw materials and packaging materialsPerforms testing of raw materials, packaging components, IP, FP and/or ST samples including dissolution, assay, related compounds analysis, content/blend uniformity, particle size distribution by Malvern/Sieve, bulk and Tap density, cleaning validation and other tests according to the analytical methods, United States Pharmacopeia (USP) procedures in a regulated laboratory environment Analyzes and interprets test resultsOperates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), UltraPerformance Liquid Chromatography (UPLC), Gas Chromatography (GC), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra-Red Spectroscopy (IR), Malvern Mastersizer, Thin Layer Chromatography (TLC) and dissolution apparatus (Distek)Collaborates closely with R&D for analytical method transfer studies and other analytical method related issuesAssists with the identification and troubleshooting of problems with instrumentation and analytical preparationsAuthors Residual Solvent, Elemental Impurity and Nitrosamine risk assessmentsMeets project deadlines and performance standards, as assigned Maintains a clean and organized lab areaComplies with all Company policies and procedures, including safety rules and regulationsAdheres to GMPs and GDPsAny other QA R&D related tasks assigned by Supervisor or QA R&D Management RequirementsQUALIFICATIONS
Minimum education and years of relevant work experience
Bachelors degree in Chemistry or related science field and minimum 3 years lab experience in a cGMP related industry OR Masters degree in Chemistry or related science field and minimum 1 years lab experience in a cGMP related industry.
Special knowledge or skills needed and/or licenses or certificates required:
Hands on experience with analytical instrumentation (i.e., UV, IR, HPLC, UPLC, Malvern Mastersizer, GC and/or dissolution instruments) in a pharmaceutical, biotechnology or academic settingProficiency with Microsoft OfficeVerbal and written communication and skillsAbility to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team membersAnalytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines Planning, organization and time management skills including the ability to support and prioritize multiple projectsFluent in English (verbal and written)Ability to identify and distinguish colorsAbility and willingness to work additional hours as required by business needs
Special knowledge or skills needed and/or licenses or certificates preferred:
Experience working with Food and Drug Administration (FDA), International Council on Harmonisation (ICH) guidelines, cGMPs and SOPs regulatory rules, regulations and guidelinesProficiency with Empower software and other laboratory softwareExperience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and proceduresPrior experience working in a QC labTravel requirements
5%
Physical requirements
Laboratory based position
• Ability to lift up to 30 lbs
• Ability to use Personal Protective Equipment (PPE)
• Ability to stand for extended periods of time
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.
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