Principal Scientist – Exploratory Product Development

Tris Pharma, Inc. (www.trispharma.com) in Monmouth Junction, NJ is a research-based drug delivery technology company with a proven track record of differentiated product development. Our Exploratory R&D group within Product Development (PD) is actively engaged in evaluation of new concepts and work areas, development of new platform drug delivery technologies, proof of concept studies and creation of commercially viable IP.   Proprietary technologies are then leveraged to develop differentiated NDA products.  We an immediate opening for a Principal Scientist to support our exploratory research programs. 

Principal Scientist in our PD Department is responsible for developing novel platform technologies from conceptualization, pre-formulation, feasibility evaluation to proof-of-concept pilot human PK studies and generating supportive IP.  She/he is also expected to support process optimization groups for scale up and manufacture of submission batches.  

• Actively participates and effectively contributes in company’s innovation programs;  Develops novel platform technologies in drug delivery to create valuable IP

• Contributes intellectually to formulation development activity leading to differentiated products

• Develops and practices understandings on biopharmaceutics of drug and impact on formulation design 

• Surveys scientific literature to remain current with the developments in pharmaceutical sciences, pharmaceutics, pharmacokinetics[;  Prepares and presents reports on research findings, project status, literature review and technical issues that affect the business

• Performs /directs relevant experiments to prove concepts;  Generates supporting data for IP filings;  Performs physical and chemical characterization in liaison with analytical teams

• Monitors unit operations performed by technicians and junior formulators to ensure accurate and effective execution of formulation development trials

• Mentors/supervises one direct report 

• Communicates across depts in cross functional meeting ensuring effective program progress;  Provides project updates and presentations in monthly technical meetings with senior management and collaborators

• Coordinates and executes cGMP manufacturing of pilot PK batches;  Supports scale up and manufacture of submission batches

• Coordinates with Clinical Affairs department for pilot PK studies: protocol review, CRO visits, PK data review and understanding;  Provides technical documents to Regulatory Affairs and Clinical Affairs to support Regulatory filings and PK studies related to API physicochemical, pharmacokinetic and pharmacodynamic properties 

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Ph.D. in Pharmaceutics/ Pharmaceutical Sciences/Industrial Pharmacy or related scientific discipline AND minimum 8 years experience in a pharmaceutical or biotechnology product development or formulation laboratory REQUIRED

• In depth, hands on experience in designing and conducting pharmaceutical formulation and process development studies with high scientific rigor, supporting multiple dosage forms REQUIRED

• Demonstrated experience and expertise in oral MR dosage form development (solids and liquids) REQUIRED

• Strong understanding of patents in relation to pharmaceutical industry REQUIRRED

• Ability to solve scientific problems under minimal supervision REQUIRED

• In depth understanding about pharmacokinetics, absorption mechanisms, reverse transport systems, saturable first pass, non-linearity of PK, impact on dosage form design REQUIRED

• Ability to train and mentor lower levels scientists REQUIRED 

• In depth understanding about Physical Pharmacy, Basic Pharmaceutics, Materials Science, Physical Chemistry PREFERRED 

• Demonstrated experience in platform technology development and/or published patents on drug delivery PREFERRED

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.