AR&D Sr. Scientist II

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. 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 >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 our team members 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. Equally 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.

Our AR&D lab is located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced Analytical Research and Development Senior Scientist II

Summary

The Analytical Research and Development (ARD) Senior Scientist II, under minimal guidance, designs and guides pre-formulation and complex physical characterization studies to facilitate understanding of material attributes and product performance. The incumbent also performs and leads pre-formulation, physical characterization and non-routine analytical method development. Serving as analytical lead for assigned projects the incumbent provides analytical input to support complex technical investigations, guides highly specialized analytical tasks and conducts research on assigned problems and studies to support product development. She/he also prepares technical reports and other relevant scientific packages for internal and external use.

ESSENTIAL FUNCTIONS

Primary duties/responsibilities

• Carries out responsibilities in accordance with company policies, Standard Operating procedures (SOPs), and state, federal and local laws
• Designs and guides complex physical characterization studies to facilitate understanding of material attributes and product performance, such as spectroscopic, rheologic, microscoic, surface area, polymorphic and thermal studies; research and implement novel techniques and instruments
• Designs, guides and performs pre-formulation studies (such as pH solubility, pH stability, excipients compatibility studies, etc.) in collaboration with Product Development (PD) department
• Designs, guides and performs non-routine and specialized method development of complex analysis, such as biorelevant dissolution method, unknown impurity identification, etc.
• Designs, guides and performs reverse engineering studies of complex reference products to support product development
• Acts as analytical R&D lead for assigned development projects and liaises with PD department on analytical deliverables
• Sets up and operates analytical instruments to support sample testing, including High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy (UV/Vis), automatic titration, Infrared Spectroscopy (IR), Thin Layer Chromatography (TLC), Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Liquid Chromatography-Mass Spectroscopy (LC-MS and LC-MS/MS), Gas Chromatography-Mass Spectroscopy (GC-MS) and dissolution apparatus
• Performs and leads analytical method development and troubleshooting of complex analytical methods in compliance with ICH/FDA guidances for raw materials, in process (IP), finished products (FP) and stability (ST) sample testing, as needed
• Performs data and trend analysis for study results
• Investigates Out of Specification (OOS) and Out of Trend (OOT) results in support of project directives, as needed
• Provides analytical input to support highly complex technical investigations
• Documents all testing details and results in laboratory notebooks compliant with current Good Documentation Practices (cGDPs); Prepares analytical method development reports, technical protocols/reports and scientific packages for internal and external use
• Troubleshoots and solves problems during routine testing, including instruments malfunction and analyst errors
• Assists and trains lower-level scientists
• Continuously improves and streamlines ARD capabilities, processes and systems, including identification and implementation of instrumentation and software
• Reviews ARD SOPs, as needed
• Safely and properly disposed of chemical waste, as needed
• Cleans, maintains and calibrates laboratory instruments to ensure compliance with current Good Laboratory Practices (cGLPs) and current Good Manufacturing Practices (cGMPs); Cleans and organizes ARD lab areas
• Performs related duties as assigned

Requirements

Requirements

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

Bachelors degree in Chemistry or related science field and minimum 15 years experience in analytical development in the pharmaceutical or biotechnology industry OR

Masters degree in Chemistry or related science field and minimum 12 years experience in analytical development in the pharmaceutical or biotechnology industry

OR PhD in Chemistry or related science field and minimum 7 years experience in analytical development in the pharmaceutical or biotechnology industry.

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

• Thorough knowledge and experience of physical characterization, thermal, spectroscopic and chromatographic techniques and concepts
• Hands on experience in setting up and operating multiple analytical instrumentation which may include: UV/Vis, HPLC, GC, TLC, ICP-MS and dissolution apparatus
• Extensive working experience in designing and executing pre-formulation, analytical and physical characterization studies with high scientific standard
• Working knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidance
• Strong technical writing and review skills, including SOPs, investigations, protocols, reports and scientific packages
• 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

Travel requirements

0%

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

Anticipated salary range: $135k to $175k. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

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. #LI-_