- Carries out responsibilities in accordance with company policies, SOPs, and state, federal and local laws
- Authors Change Controls and performs/updates development stage documents, as required, (i.e., specifications in accordance with test method changes, component changes, qualification of alternate sourced drug substances)
- Performs testing for 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 results
- Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), Ultra Performance 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); Creates and uses custom fields in Empower software while operating HPLC/UPLC and GC instruments
- Collaborates closely with R&D for analytical method transfer studies and other analytical method related issues
- Assists/performs identification and troubleshooting of problems with instrumentation, analytical anomalies and laboratory investigations
- Trains and mentors lower level chemists and assists them during routine analysis
- Authors Residual Solvent, Elemental Impurity and Nitrosamine risk assessments
- Authors or updates SOPs, as needed
- Meets project deadlines and performance standards, as assigned
- Maintains a clean and organized lab area
- Complies with all company policies and procedures, including safety rules and regulations
- Any other QA R&D related tasks assigned by Supervisor or QA R&D Management
Requirements
QUALIFICATIONSMinimum education and years of relevant work experience:
Bachelors degree in Chemistry or related science field and minimum 7 years lab experience in a cGMP related industry in positions of increasing technical responsibility OR Masters degree in Chemistry or related science field and minimum 3 years lab experience in a cGMP related industry.
Special knowledge or skills needed and/or licenses or certificates required:
- In-depth, hands on experience with analytical instrumentation (i.e., UV, IR, HPLC, UPLC, Malvern Mastersizer, GC and/or dissolution instruments) in a pharmaceutical or biotechnology setting
- In-depth, hands on experience performing and interpreting analytical results and performing laboratory investigations
- In-depth, hands on experience with analytical method verifications and method transfers
- Proficiency with Microsoft Office
- Verbal and written communication and skills
- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
- Analytical 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 projects
- Fluent in English (verbal and written)
- Ability to identify and distinguish colors
- Ability and willingness to work additional hours as required by business needsSpecial 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 guidelines
- Proficiency with Empower software
- Experience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures
- Prior 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
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SR. QA R&D Chemist - 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.
Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a QA R&D Senior Chemist
SUMMARY:
The Quality Assurance (QA) Research and Development (R&D) Senior Chemist takes a leadership role for other chemists on the QA R&D team in supporting Quality Control (QC) and Analytical R&D (AR&D) activities. These 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.
She/he is also responsible for training/mentoring junior chemists, performing laboratory investigations and root cause determinations, initiating and drafting investigations, Standard Operating Procedures (SOPs) and revising analytical methods etc. Collaborating closely with Analytical Research and Development (AR&D) and Method Validation teams, the incumbent develops and demonstrates advanced analytical knowledge and expertise while carrying out laboratory work to support R&D activities and performing special projects, as assigned.
ESSENTIAL FUNCTIONS
