About This Role
This role is for a Product Development (PD) Research Scientist II to join the Platform and Product Feasibility (PPF) team at a biopharmaceutical company. The scientist plans and executes pre-formulation and formulation activities, contributing to the development of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept. The role also involves planning and executing pilot-phase process development activities and manufacturing cGMP pilot batches, while collaborating with Analytical and Project Management to meet project timelines and milestones.
Responsibilities
- Carry out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws
- Plan and execute pre-formulation and formulation activities with good scientific standards to assess feasibility of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC)
- Generate supporting data for Intellectual Property (IP) and create relevant invention disclosure forms
- Plan, coordinate and execute cGMP pilot batches, including protocols, master batch records and reports, under the guidance of senior staff
- Document all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (GDPs) and cGMP
- Summarize data, discuss results and make conclusions in technical reports
- Perform physical and chemical characterization in liaison with analytical teams
- Ensure cleanliness and functioning of lab areas and proper maintenance of equipment and instruments
- Collaborate with Analytical and Project Management to ensure project timelines and study milestones are met
- Present and update project status and issues/challenges to management
- Collaborate with, and assist, Clinical Development with the coordination of pilot PK studies, including protocol review, submission of pilot batches to Contract Research Organizations (CROs), Pharmacokinetics (PK) data review and understanding
- Author regulatory submission documents for Pre-Investigational New Drugs (Pre-INDs) and Investigational New Drug Applications (INDs), covering pre-formulation and formulation development
- Create and revise SOPs, as needed
- Collaborate with Quality Assurance (QA) on investigations, Corrective Action Preventive Action (CAPAs) and Change Controls to ensure timely closure
Requirements
- Master's degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND 3-5 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry OR
- Ph.D. degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline AND 0-2 years experience in a product development or formulation laboratory in the pharmaceutical or biotechnology industry
- Hands on experience in designing and conducting pharmaceutical formulation and process development studies with high scientific rigor, supporting multiple dosage forms (i.e., solid, liquid and/or extended release, etc.)
- Good understanding of Physical Pharmacy and Pharmaceutics
- Good technical writing skills, including SOPs, investigations, protocols, reports
- Working knowledge of Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), Drug Enforcement Administration (DEA), cGMPs and GLPs regulations and guidances
Benefits
- Bonus eligible
- Medical, dental, vision, Rx insurance
- 401K with match
- Life insurance
- Paid Company Holidays
- PTO
- Paid Volunteer Time
- Employee Resource Groups
About the Company
Tris Pharma, Inc. is a privately-owned US biopharmaceutical company focused on the development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction. The company holds over 150 US and International patents and markets several branded ADHD products in the US, also licensing its products in the US and ex-US markets. Its pipeline spans neuroscience and other therapeutic categories, employing proprietary science and technology.
