Method Validation R&D Senior Scientist I

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We 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 fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each team member is how we interact with one another on a daily basis. We believe in each other and 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

Method Validation R&D Senior Scientist I

Summary:

The Method Validation (MV) Research and Development (R&D) Senior Scientist I, under minimal guidance, performs analytical method validations and release/stability raw materials, in process (IP), finished products (FP) and stability (ST) samples for pilot and submission batches, according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) procedures. The incumbent prepares, coordinates and advances required documentations, in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs), methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management, conducts laboratory investigations and recommends appropriate Corrective Action Preventive Action (CAPAs)/CPIs ensuring timely and accurate closure, guides highly specialized analytical tasks, researches assigned problems and studies to support MV, method transfer and complex technical investigations and assists and trains lower level scientists.

Responsibilities:

• Carries out responsibilities in accordance with company policies, SOPs, and state, federal and local laws Performs validation of analytical methods and release/stability testing for raw materials, IP, FP and ST samples of pilot/pivotal/submission batches using High Pressure Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), Infrared spectroscopy (IR), Atomic Adsorption (AA), Thin Layer Chromatography (TLC), dissolution apparatus, etc.
• Acts as MV lead for assigned projects and regularly reports status/issues to management
• Prepares MV protocols and reports, as well as test methods and procedures
• Prepares CCRs, according to change control process
• Coordinates, advances and monitors progress for all required documentations and change control activities, in liaison with PD/QA/QC/Regulatory Affairs
• Designs experimental plans; Critically analyzes data and information gathered during method validation for possible discrepancies
• Documents all testing details and results in laboratory notebooks and report sheets, compliant with current Good Documentation Practices (cGDPs), cGMPs and SOPs
• Evaluates compendial methods and procedures, as needed
• Prepares regulatory submissions; Executes studies and prepares technical protocols/reports in response to FDA Information Requests (IRs)/Complete Response Letters (CRLs)
• Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and cGMPs; Cleans and organizes MV lab areas
• Monitors sample flow, testing status and ensures result accuracy
• Searches and reviews scientific literature to remain current with developments in analytical chemistry, physical characterization and pharmaceutical testing
• Prepares non-conformance, Out of Trend (OOT), Out of Specification (OOS) and other investigations, and recommends CAPAs/CPIs, to ensure timely closure
• Assists and trains lower level scientists
• Identifies appropriate instrumentation and software programs to improve MV lab capabilities
• Creates MV SOPs, as needed
• Performs related duties, as assigned

Requirements

Requirements

Minimum education and years of relevant work experience:

Bachelors degree in Chemistry or related science field and minimum 10 years experience in analytical development and/or MV in the pharmaceutical industry OR Masters degree in Chemistry or related science field and minimum 8 years experience in analytical development and/or MV in the pharmaceutical industry OR PhD in Chemistry or related science field and minimum 3 years experience in analytical development and/or MV in the pharmaceutical industry.

Special knowledge or skills needed and/or licenses or certificates required

• Strong knowledge and experience of physical characterization, thermal, spectroscopic and chromatographic techniques and concepts
• Strong knowledge of advanced chemistry, pharmaceutical and statistical theories, methods and procedures
• Extensive experience in setting up, operating and troubleshooting multiple analytical instrumentation which may include: UV, IR, HPLC, LC-MS, GC, GC-MS, ICP-MS, TLC and dissolution apparatus
• Working knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidances
• Thorough knowledge of MV parameters and relevance in method performance and method life cycle management
• Strong technical writing skills, including SOPs, investigations, protocols and reports
• Ability to train and mentor lower levels scientist
• 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

Special knowledge or skills needed and/or licenses or certificates preferred

Proficiency with Empower software

Travel requirements

0%

Physical requirements

• Ability to lift up to 30 lbs
• Ability to use Personal Protective Equipment (PPE)

Ability to stand for extended periods of time

Physical requirements

Office based position