Senior Scientist, Product Development Exploratory R&D

Employer
Tris Pharma
Location
Monmouth Junction, NJ
Posted
Jul 19, 2021
Ref
573817
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time

  

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest specialty pharmaceutical company in the United States. We are a research-based drug delivery technology company with proven track record of differentiated product development. The Exploratory Research and Development (R&D) group within Product Development (PD) Department 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 New Drug Applicant (NDA) products. We have an opening for a Senior Scientist to support exploratory research programs. 

The Senior Scientist in Product Development (PD) Department is responsible for developing novel platform technologies from conceptualization, pre-formulation, feasibility evaluation to proof-of-concept pilot human Pharmacokinetics (PK) studies, generating supportive IP. She/he also supports process optimization group for scale up and manufacture of submission batches. 

ESSENTIAL FUNCTIONS 

• Actively participates and effectively contributes in company’s innovation program by supporting development of 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 its impact on formulation design 

• Surveys the scientific literature to remain current with the developments in pharmaceutical sciences, pharmaceutics, pharmacokinetics and adds technical competence

• Prepares and presents reports on research findings, project status, literature review and technical issues that affect the business

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

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

• Communicates across depts in cross functional meeting ensuring effective program progress

• Provides project updates in the form of presentations in monthly technical meetings held with Senior Management and/or collaborators

• Coordinates and executes current Good Manufacturing Practices (cGMP) manufacturing of pilot PK batches 

• Supports scale up and manufacture of submission batches

• Coordinates with Clinical Affairs department for pilot PK studies including protocol review, Clinical Research Organization (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

Requirements

  

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

Masters in a scientific or engineering discipline AND minimum 10 years experience in a product development or formulation laboratory in a pharmaceutical, biotechnology or academic environment OR PhD in Pharmaceutics/ Pharmaceutical Sciences/Industrial Pharmacy or related scientific discipline AND minimum 7 years experience in a product development or formulation laboratory in a pharmaceutical, biotechnology or academic environment. Job title and level determination will be commensurate with experience.

Special knowledge or skills needed and/or licenses or certificates required

• In depth understanding of physical pharmacy, basic pharmaceutics and materials science 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

• Demonstrated experience in platform technology development REQUIRED

• Strong understanding of patents REQUIRED

• 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

• Understanding and experience in biorelevant method development, establishment of IVIVC, local physiology of GI tract and its impact REQUIRED

· Published patents on drug delivery PREFERRED 

· Experience in parenterals including injectable depots 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. #LI-DNI