Tris Pharma · 3 days ago
PD Senior Scientist I/II
Monmouth Junction, NJ
Full-time
Onsite
Mid, Senior Level
$100K/yr - $125K/yr
3+ years expTris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company focused on innovative medicines in ADHD and other disorders. The Product Development Senior Scientist will design and conduct formulation and process development activities, ensuring compliance with regulatory standards and collaborating with various teams to meet project timelines.
BiotechnologyLife ScienceManufacturingMedicalPharmaceutical
Responsibilities
Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws
Designs, plans and conducts product development activities, including pre-formulation, formulation, process development and scale up studies of complex projects to ensure good scientific standards are met
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; Meets project deadlines and performance standards, as assigned
Creates invention disclosures; Collaborates with internal and external counsel to perform patent landscape analysis, draft patent applications, and respond to office actions
Utilizes risk-based approaches and Quality by Design (QbD) principles in guiding pharmaceutical development and identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) and control strategies. Uses problem solving tools to trouble shoot, as needed
Designs and conducts physical and chemical characterization in liaison with analytical teams
Performs critical data analysis using statistical tools including stability analysis
Plans, coordinates and manufactures cGMP pilot and pivotal batches, including drafting of protocols, master batch records and reports
Liaises, coordinates and manages PD activities with external labs, Clinical Research Organizations (CROs) and Clinical Development Manufacturing Organizations (CDMOs), including cGMP manufacturing activities; Collaborates closely with other functions within and outside R&D to ensure project timelines are met
Presents and updates project status and issues/challenges to management
Supports technical services and operations to trouble-shoot scale up and commercial processes
Collaborates with, and assists, Regulatory Affairs with coordination and submission of pivotal batches to CROs
Ensures cleanliness and functioning of PD areas and proper maintenance of equipment and instruments; Supports review of qualification documents for process equipment
Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports
Creates and revises 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
Participates in training of new employees and mentors lower level scientists
Qualification
Required
Bachelors degree in Pharmaceutical Science or related scientific field and minimum 10 years experience in pharmaceutical formulation and product development OR
Masters degree in Pharmaceutical Science or related scientific field and minimum 8 years experience in pharmaceutical formulation and product development
PhD in Pharmaceutical Science or related scientific field and minimum 3 years experience in pharmaceutical formulation and product development
Bachelors degree in Pharmaceutical Science or related scientific field and minimum 15 years experience in pharmaceutical formulation and product development OR
Masters degree in Pharmaceutical 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 experience designing and conducting oral controlled release solids and liquids pharmaceutical formulation and process development studies with high scientific standard of multiple dosage forms
Working knowledge of QbD and risk-based approaches
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 skills and experience (i.e., SOPs, investigations, protocols, reports, submission documents, etc.)
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 problem-solving skills and the ability to adapt to changing priorities and deadlines
Planning, organization and time management skills including the ability to support and prioritize multiple projects
Fluent in English (verbal and written)
Ability to distinguish colors
Benefits
Bonus eligible
Medical
Dental
Vision
Rx insurance
401K with match
Life insurance
Paid Company Holidays
PTO
Paid Volunteer Time
Employee Resource Groups
Company
Tris Pharma
Tris Pharma is a pharmaceuticals company providing specialty generic products.
501-1000 employees
H1B Sponsorship
Tris Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (21)
2023 (20)
2022 (17)
2021 (16)
2020 (33)
Funding
Current Stage
Late StageTotal Funding
$141.6MKey Investors
National Institute on Drug Abuse (NIDA)Deerfield
2023-08-28Grant· $16.6M
2018-10-05Debt Financing· $125M
Leadership Team
Franchesca M. Fowler
General Counsel, Vice President and Chief Compliance Officer
J
James Hackworth
President, Brand Division
Recent News
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