Principal Product Development Scientist

The opportunity

We are seeking a highly skilled and motivated Scientist to join our Oral Solid Dosage Formulation Development team. This role involves leading the design and development of oral solid dosage forms through NDA and ANDA filings and / or product launches. The ideal candidate will bring deep expertise in formulation strategies, process development, and regulatory submissions.

How you’ll spend your day

• Design and develop oral solid dosage forms (immediate and extended release) from concept through regulatory submission and product launch.
• Develop and execute formulation strategies, including project planning, experimental design, data analysis, and coordination with cross-functional teams (Analytical Sciences, Legal & Regulatory, Pharma Tech).
• Maintain expertise in controlled release technologies and contribute to innovation in drug delivery systems.
• Identify and implement improvements in R&D processes, technologies, and regulatory compliance.
• Conduct pre-formulation and formulation development work; generate and review analytical data to support product development.
• Author protocols, batch records, and documentation for scale-up and pivotal batch manufacturing.
• Plan and oversee analytical testing and stability studies for pivotal batches.
• Prepare comprehensive documentation including Product Development Reports (PDR), Quality Overall Summaries (QOS), and other regulatory filing materials.
• Conduct literature reviews and patent searches to stay current with industry trends and regulatory changes.
• Plan and evaluate bioequivalence studies; recommend formulation changes based on data.
• Ensure compliance with cGMP, cGLP, SOPs, FDA, and DEA regulations.
• Provide scientific and technical guidance to junior staff to meet project goals and timelines.
• Collaborate with supervisor to set priorities and achieve objectives.

Your experience and qualifications

Bachelor’s degree with 8 years of progressive experience in lieu of the above.

Oral solid dosage formulation development Immediate and extended release dosage forms Process development NDA / ANDA submissions

TRAVEL REQUIREMENTS : Up to 10%

Enjoy a more rewarding choice

We offer a competitive benefits package, including :

Comprehensive Health Insurance : Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Retirement Savings : 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.

Time Off : Paid Time Off including vacation, sick / safe time, caretaker time and holidays.

Life and Disability Protection : Company paid Life and Disability insurance.

Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.