QC Analytical Senior Chemist I

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 Quality Control Department is growing and we have an opening for QC Analytical Senior Chemists I. This is a 1st shift position working Monday-Friday in our Monmouth Junction, NJ laboratories.

The Senior Quality Control (QC) Analytical Chemist performs analytical testing of raw materials, packaging components, in-process (IP), finished product (FP), stability samples (ST), analytical method transfers and method verifications following analytical methods, United States Pharmacopeia (USP)/National Formulary Chapters, protocols, Standard Operating Procedures (SOPs) under current Good Manufacturing Practices (cGMPs) and company policies.

The incumbent is also responsible for training/ mentoring junior chemists, performing laboratory investigations and root cause determinations, initiating and drafting investigations, SOPs and revising analytical methods etc. Collaborating closely with, and under the direct supervision of Team Leads, and QC Managers, she/he develops and demonstrates advanced analytical knowledge and expertise while carrying out laboratory work to support QC activities and performs special projects, as assigned

ESSENTIAL FUNCTIONS

• Carries out responsibilities in accordance with company policies, SOPs and state, federal and local laws
• Performs testing of raw materials, in-process (IP), finished products (FP) and/or stability sample (ST) samples including dissolution, assay, content/blend uniformity, particle size distribution and other tests according to the analytical methods, USP procedures in a regulated laboratory environment.
• Performs analytical method transfers and method verifications
• Analyzes and interprets test results
• Operates general analytical instruments during raw material, IP and FP testing such as High Pressure Liquid Chromatography (HPLC), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra-Red Spectroscopy (IR), Atomic Absorption (AA), Thin Layer Chromatography (TLC) and dissolution apparatus (Distek)
• Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations
• Complies with all company policies and procedures, including safety rules and regulations
• Adheres to GMPs and current Good Documentation Practices (GDPs)
• Hands-on experience with analytical instrumentation (i.e., UV, IR, HPLC, GC and/or dissolution instruments) in a pharmaceutical or biotechnology setting
• Strong hands-on experience performing and interpreting Related Compounds analysis (Impurity analysis)
• Demonstrated ability to apply good laboratory techniques while maintaining efficiencies required in a QC lab

Requirements

Minimum education and years of relevant work experience:

Senior Chemist I - Bachelors degree in Chemistry or related science field and minimum 4 years lab experience in a cGMP related industry in positions of increasing technical responsibility.

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

• In-depth, hands on experience with analytical instrumentation (i.e., UV, IR, HPLC, 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
• Demonstrated ability to apply good laboratory techniques while maintaining the efficiencies required in QC lab
• Proficiency with Microsoft Office
• 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 and/or experience training and mentoring lower level chemists
• Ability and willingness to work additional hours as required by business needs
• Excellent ability to identify and distinguish colors

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

• Experience working with Food and Drug Administration (FDA), current Good Laboratory Practices (cGLPs), 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

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

QC Analytical Senior Chemist I

Anticipated Salary range: $85-100k

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, all 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-onsite