Require Product Development R&D Scientist

Worker Category: Full Time Exempt Full-Time

PRODUCT DEVELOPMENT - R&D SCIENTIST

Tris Pharma, Inc. (www.trispharma.com) is a rapidly growing, technology-driven pharmaceutical company engaged in branded and generic product development.  Located in Monmouth Junction, New Jersey, Tris is recruiting for Product Development R&D Scientists. 

Product Development R&D Scientists perform pre-formulation and formulation development activities, prepares formulation batches for compatibility studies, stability studies, Pilot batches and Pivotal batches, perform maintenance of Research and Development (R&D) equipment/instruments.

RESPONSIBILITIES:  

·      Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.

·      Reverse engineering of existing marketed product with respect to physical and chemical characterization.

·      Pre-formulation studies including drug-excipient compatibility studies.

·      Preparation of formulation batches on laboratory scale and submitting samples for chemical analysis.

·      Records all the processes and results in laboratory notebooks as required by Standard Operating Procedures (SOPs).

·      Assists in the documentation and execution of Pilot batches.

·      Execution of scale-up trials as per Quality by Design (QbD) principles.

·      Confirms that the laboratory equipments are cleaned after every batch to ensure compliance with current Good Laboratory Practices (cGLP) and current Good Manufacturing Practices (cGMP).

·      Meets project deadlines and performance standards as assigned.

·      Complies with all Company policies and procedures, including safety rules and regulations.

QUALIFICATIONS:

·     Bachelor's Degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related science field from an accredited college or university, and a minimum of three (3) years related pharmaceutical laboratory experience OR a Master's degree with minimum of one (1) year of experience in pharmaceutical industry or an equivalent combination of education and experience.

·     Exposure to pharmaceutical manufacturing and general working knowledge of pharmaceutical manufacturing required; solid, liquid and/or extended release experience preferred.  

·     Experience designing and conducting formulation and process development preferred.

·     Experience working with Food and Drug Administration (FDA), cGLP, cGMP, and SOP regulatory rules, regulations and guidelines preferred.

·     Excellent written and oral communication skills required.

·     Experience with Empower 3 or related lab software preferred.

·     Proficient with Microsoft Office – Word and Excel required.

·     Ability to effectively interact with others required.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. Tris Pharma, Inc. is an Equal Opportunity Employer.

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