Product Development Scientist - ALL LEVELS

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest specialty pharmaceutical company in the United States. With our intense focus on the application of physical chemistry in biological systems, coupled with the requirements of manufacturing and market demands, we have grown our employee base over 250% in the past three years. Specifically, we are engaged in research, development, and manufacturing of both OTC and Rx branded products and specialty generic products. Our mission is to understand the science driving the delivery of drugs into the human body; develop and bring to market products that add value to our customers and patients and provide a benefit to our company, employees and society at large. 

Tris is expanding the Laboratories at our Monmouth Junction, NJ facility and has openings for all levels for Product Development Scientists.  

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 manufactures 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

Bachelors degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND minimum 3 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry OR 

Masters degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND minimum 2 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry.

 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

• 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.