QC Analytical Chemist

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.

Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Quality Control (QC) Analytical Chemist.

The 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.

Collaborating closely with, and under the direct supervision of Senior QC Analytical Chemists, Team Leads and QC Managers, the incumbent develops advanced analytical knowledge and expertise while carrying out laboratory work to support QC activities and performs special projects, as assigned.

Responsibilities:

* Carries out responsibilities in accordance with company policies, SOPs, and state,

* federal and local laws

* Performs testing of raw materials, 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), UltraPerformance Liquid Chromatography (UPLC), Gas Chromatography (GC), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra-Red Spectroscopy (IR), Atomic Absorption (AA), Malvern Particle size analyzer, Thin Layer Chromatography (TLC) and dissolution apparatus (Distek)

* Displays proficiency in creating and using custom fields in Empower software while operating HPLC/UPLC and GC instruments

* Assists with the identification and troubleshooting of problems with instrumentation and analytical preparations

* Meets project deadlines and performance standards, as assigned

* Compiles with all Company policies and procedures, including safety rules and regulations

* Adheres to cGMPs and current Good Documentation Practices (cGDPs)

Requirements

Requirements

Minimum education and years of relevant work experience:

Chemist I - Bachelors degree in Chemistry or related science field and minimum 1-5 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, 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

* 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 willingness to work additional hours as required by business needs

* 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, SOPs and regulatory rules, regulations and guidelines

* Proficiency with Empower software

* Ability and/or experience training and mentoring lower level chemists

* 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

Anticipated salary range: $65k - $80k 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-