Title: Platform and Product Feasibility (PPF) / Product Development (PD) Senior Scientist II
Location: Monmouth Junction, NJ
Schedule: Onsite- Monday-Friday
Type: Permanent, Direct Hire

Overview: Our client is a leading privately-owned biopharmaceutical company in the U.S. Their focus is on the development and commercialization of innovative medicines that address unmet patient needs and they have more than 150 U.S. and International patents including applications.

Requirements:

• Early Phase Product development experience
• BS degree Pharma/science with 15 years experience in pharmaceutical formulation and product development
• OR Masters degree in Pharma/Science or related scientific field and minimum 12 years experience in pharmaceutical formulation and product development
• OR PhD in Pharmaceutical Science or related scientific field and minimum 7 years experience in pharmaceutical formulation and product development.
• In-depth knowledge and experience in designing and conducting pre-formulation, formulation and process development studies to assess innovative concepts and delivery platforms with high scientific standards
• Strong working knowledge of innovative dosage form designs, in particular oral controlled release solids and liquids 
• Understanding of physical pharmacy, pharmaceutics and material sciences
• Working knowledge of pharmacokinetic and biopharmaceutic principles
• Understanding of patent process
• Proficiency with Empower software
• Ability to lift up to 30 lbs
• Ability to use Personal Protective Equipment (PPE)
• In-depth, working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines
• Strong technical writing and review skills, including SOPs, investigations, protocols, reports and submission documents
• Proficiency with Microsoft Office
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written) 

Responsibilities:

• Under minimal guidance, designs, plans and conducts all pre-formulation and formulation development activities using sound scientific approaches to assess feasibility of complex innovative concepts and generate supporting data for Intellectual Property (IP).
• The incumbent plans, coordinates and oversees execution of process development activities and current Good Manufacturing Practices (cGMPs) pilot batches, including all required documentation, develops project goals and timelines and performs critical data analysis and modeling using statistical tools.
• Prepares/reviews technical reports, early regulatory submission documents and other relevant scientific information packages for internal and external use.
• Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws
• Designs, plans and conducts all pre-formulation and formulation development activities using sound scientific approaches to assess feasibility of complex innovative concepts and generate supporting data for IP under minimal guidance
• Searches and reviews scientific literature to remain current with the developments in drug delivery technologies, pharmaceutical sciences, pharmaceutics, and pharmacokinetics
• Documents all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (cGDP) and cGMP. Summarizes data, discusses results and makes conclusions in technical reports
• Creates invention disclosures; Collaborates with internal and external counsel to perform patent landscape analysis, draft patent applications and responds to office actions
• Utilizes problem solving tools to trouble shoot formulation-related issues
• Designs and interprets physical and chemical characterization in liaison with analytical teams
• Performs critical data analysis and modeling using statistical tools, including stability, In Vitro In Vitro Correlation (IVIVC) and PK modeling; Uses problem solving tools to troubleshoot
• Plans, coordinates and oversees cGMP pilot batches, including reviews of protocols, master batch records and reports
• Liaises, coordinates and manages early development activities with external labs and Clinical Research Organizations (CROs) and Clinical Development and Manufacturing Organizations (CDMOs), including cGMP manufacturing activities
• Develops project goals, milestones and timelines in alignment with company goals; Collaborates with Research and Development (R&D) and Project Management to ensure project deadlines are met
• Presents and updates project status and issues/challenges to management and senior leadership
• Ensures cleanliness and functioning of PD lab areas, equipment and instruments are properly maintained; Reviews qualification documents for process equipment
• Authors and reviews regulatory submission documents for Pre-Investigational New Drugs (INDs) and Investigational New Drugs (INDs), covering pre-formulation and formulation development
• Authors and reviews scientific information packages for internal and external use
• Creates and reviews PD Standard Operating Procedures (SOPs), as needed
• Collaborates with Quality Assurance (QA) department on investigations, Corrective Action Preventive Action (CAPAs) and changes controls, as needed; Supports Technical Services and Operations departments to troubleshoot scale up and commercial processes
• Trains new employees and mentors lower level scientists

Benefits
Our client provides a comprehensive benefits package. Their benefits include competitive salaries, 401(k) plans with company match, medical, dental, and vision insurance, paid time off (vacation, sick leave, personal leave), paid parental leave, tuition reimbursement, life insurance, disability insurance, employee assistance program, on-site fitness center, free snacks and drinks, and casual dress code.

• As this is a direct hire with our client System One benefits described below would not apply to this role. Benefits program listed above would be those applicable to this role. 

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