Product Development Scientist I/II

Tris Pharma, Inc. (www.trispharma.com) 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. 

Tris is expanding the Laboratories at our Monmouth Junction, NJ facility and has openings for Product Development Scientists Levels I or II. 

PD Scientist are responsible for conducting pre-formulation, formulation and process development studies as well as manufacturing GMP pilot and pivotal batches to support regulatory submissions and business needs, under the guidance of senior staff. 

ESSENTIAL FUNCTIONS 

Primary duties/responsibilities

• Carries out responsibilities in compliance with all cGMP, Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Occupational Safety and Health Administration (OSHA) regulations, as well as all applicable company compliance guidelines, policies, standards and objectives.

• Efficiently executes product development activities, including pre-formulation, formulation and process development studies with good scientific standards, under the guidance of senior staff. 

• Coordinates sample testing with analytical teams and performs characterization as required.

• Supports manufacture of GMP pilot and pivotal batches, including drafting of protocols and batch records and reports.

• Creates and revises Standard Operating Procedures (SOPs) as needed. 

• Supports investigations, Corrective Action Preventive Actions (CAPAs) and change controls as required.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

PhD degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND minimum 1 year experience in a product development or formulation laboratory in pharmaceutical, biotechnology or related academic research environment 

-- OR --

MS degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND minimum 2 – 5 years experience in a product development or formulation laboratory in pharmaceutical, biotechnology or related academic research environment

Job title and level determination will be based on education and years of experience.

• Hands on experience conducting pharmaceutical formulation and process development studies REQUIRED

· Thorough understanding of pharmaceutical solid dose manufacturing REQUIRED. Multiple dosage forms PLUS

• Ability to work collaboratively, as required, in a fast paced, matrixed, team environment REQUIRED

• Working knowledge of FDA, OSHA, DEA, cGMPs and GLPs regulations and guidances REQUIRED

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. 

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