Product Development Research Scientist II

BioSpace; South Brunswick (NJ); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Life insurance

Paid company holidays

Paid time off

Job summary

Tris Pharma, Inc. is seeking two PD Research Scientists II at our Monmouth Junction, NJ facility to join the Platform and Product Feasibility (PPF) team.

You will plan and execute pre-formulation and formulation activities, contributing to development of novel drug delivery platforms and IP from concept to PoC. The role includes planning cGMP pilot batches, documenting results, and collaborating with Analytical and Project Management to meet milestones; you will prepare regulatory submissions

Qualifications

• Masters 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
• 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 REQUIRED
• 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.) REQUIRED
• Good understanding of Physical Pharmacy and Pharmaceutics REQUIRED
• Good technical writing skills, including SOPs, investigations, protocols, reports REQUIRED
• Working knowledge of FDA, OSHA, DEA, cGMPs and GLPs regulations and guidances REQUIRED

Responsibilities

• Plans and executes pre-formulation and formulation activities to assess feasibility of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC); generates data for IP and creates invention disclosures
• Plans, coordinates and executes cGMP pilot batches, including protocols, master batch records and reports, under the guidance of senior staff
• Documents all study details and results in laboratory notebooks and batch records compliant with GDPs and cGMP; summarizes data, discusses results and makes conclusions in technical reports
• Performs physical and chemical characterization in liaison with analytical teams
• Ensures cleanliness and functioning of lab areas and proper maintenance of equipment and instruments
• Collaborates with Analytical and Project Management to ensure project timelines and study milestones are met; presents status to management
• Collaborates with Clinical Development to coordinate pilot PK studies and submits data to CROs; reviews PK data for regulatory understanding
• Authors regulatory submission documents for Pre-INDs and INDs
• Creates and revises SOPs, and collaborates with QA on investigations, CAPAs and Change Controls

Skills

Pharmaceutical formulation

Pre-formulation

Process development

Technical writing

Education

Masters degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline

Ph.D. degree in Pharmaceutical Sciences/Pharmaceutics/Industrial Pharmacy or related scientific discipline

Job description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

Our science and technology make us unique, but our team members set us apart; they’re the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We have an immediate opening at our Monmouth Junction, NJ facility for two (2) Product Development (PD) Research Scientists II to join our Platform and Product Feasibility (PPF) team.

The PD Research Scientist II plans and executes pre-formulation and formulation activities, contributing to development of novel drug delivery platforms and differentiated products from conceptualization to pilot proof of concept (PoC) thereby creating commercially viable intellectual property (IP). The incumbent also plans and executes pilot-phase process development activities and manufacture of current Good Manufacturing Practices (cGMPs) pilot batches, including all required documentation. The incumbent also collaborates with Analytical and Project Management to ensure project timelines and study milestones are met. She/he prepares technical reports including, but not limited to: feasibility reports, invention disclosures, early phase regulatory submission documents etc.

Primary Responsibilities Include

• Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws
• Plans and executes 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); generates supporting data for Intellectual Property (IP) and creates relevant invention disclosure forms
• Plans, coordinates and executes cGMP pilot batches, including protocols, master batch records and reports, under the guidance of senior staff
• Documents all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (GDPs) and cGMP; Summarizes data, discusses results and makes conclusions in technical reports
• Performs physical and chemical characterization in liaison with analytical teams
• Ensures cleanliness and functioning of lab areas and proper maintenance of equipment and instruments
• Collaborates with Analytical and Project Management to ensure project timelines and study milestones are met; Presents and updates project status and issues/challenges to management
• Collaborates with, and assists, 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
• Authors regulatory submission documents for Pre-Investigational New Drugs (Pre-INDs) and Investigational New Drug Applications (INDs), covering pre-formulation and formulation development
• Creates and revises SOPs, as needed
• Collaborates with Quality Assurance (QA) on investigations, Corrective Action Preventive Action (CAPAs) and Change Controls to ensure timely closure

Requirements

• Masters 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 REQUIRED
• 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.) REQUIRED
• Good understanding of Physical Pharmacy and Pharmaceutics REQUIRED
• Good technical writing skills, including SOPs, investigations, protocols, reports REQUIRED
• Working knowledge of Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), Drug Enforcement Administration (DEA), cGMPs and GLPs regulations and guidances REQUIRED

Anticipated Salary Range

Masters degree and 3-5 years experience - $ 90 to $ 115K/yr.

PhD degree and 0-2 years experience - $ 85 to 110K/yr.

Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

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.