Senior Scientist, Manufacturing Science & Technology (Biotech)

Description:

The Senior Scientist, MS&T, is responsible for contributing to research and development activities across the product lifecycle—from pre-formulation through product development to successful commercialization. This role contributes to the scientific and technical aspect of designing robust formulations, optimizing manufacturing processes, and ensuring seamless technology transfer.

Schedule:

8am - 4:30pm Monday to Friday, Fully Onsite

Essential Functions:

• Collaborate in the design and development of a range of pharmaceutical dosage forms, including modified-release and immediate-release oral solids and powders for suspension, contributing to cross-functional team efforts. Apply a deep understanding of formulation science, material properties, and pharmacokinetics to ensure robust product performance. Guide formulation strategies that align with therapeutic goals, regulatory expectations, and commercial feasibility.
• Write and critically review process performance qualification (PPQ) protocols and reports, cleaning verification and validation protocols, and other technical study plans required throughout the product lifecycle. Ensure all documentation meets regulatory standards and supports a state of control in manufacturing processes. Collaborate with Quality Assurance and Validation teams to ensure seamless execution and compliance.
• Implement timely execution of projects starting with the selection of raw materials, packaging components, formulation strategy, scientific development and process scale up.
• Draft comprehensive technical reports and project presentations that clearly communicate development progress, scientific rationale, and outcomes. Collaborate closely with Analytical Development, Regulatory Affairs, and Manufacturing teams to align on project goals, resolve challenges, and meet submission timelines. Evaluate analytical data to inform formulation decisions and ensure product quality.
• Provide mentorship and technical guidance to junior scientists in experimental design, data interpretation, and troubleshooting. Foster a collaborative and innovative lab environment that encourages scientific curiosity and continuous learning.
• Apply scientific creativity and critical thinking to solve complex formulation and process development problems. Leverage literature, prior knowledge, and experimental data to propose and implement effective solutions. Contribute to the preparation of regulatory documents such as ANDA submissions, ensuring clarity, accuracy, and scientific justification.
• Provide technical support for both commercial and non-commercial manufacturing operations. Troubleshoot formulation and process-related issues, identify root causes, and implement corrective actions. Recommend process improvements to enhance efficiency, yield, and product quality, contributing to continuous improvement initiatives across the organization.

Additional Responsibilities:

• Other duties as assigned.

 

Education:

• Bachelors Degree (BA/BS) in chemistry or other relevant Pharmaceutical Sciences - Required
• Master Degree (MS/MA) in chemistry or other relevant Pharmaceutical Sciences - Preferred
• Ph. D. in chemistry or other relevant Pharmaceutical Sciences - Preferred

Experience:

• 8 years or more in Experience in the pharmaceutical development demonstrating the application of scientific principles (with Bachelor's Degree)
• 6 years or more in Experience in the pharmaceutical development demonstrating the application of scientific principles (with Master's Degree)
• less than one year in Experience in the pharmaceutical development demonstrating the application of scientific principles (with Ph.D.)

Skills:

• Enthusiasm and dedication performing as an individual contributor and in a team environment - Intermediate
• Good written and verbal communication and presentation skills. - Intermediate
• Ability to search pertinent literature, design experiments independently and work with junior level scientists to achieve goals. - Intermediate
• Ability to set priorities and follow through on commitments utilizing organizational skills - Intermediate
• Ability to lead projects, and meet deadlines. - Intermediate
• Microsoft Office and ability to learn additional software/programs as needed. - Intermediate
• Creativity to solve technical and compliance problems. - Intermediate

Specialized Knowledge:

• In depth knowledge of pharmaceutical chemistry and understanding of pharmaceutics in developing complex dosage forms and drug delivery systems
• Knowledge of Pharmaceutical process validation techniques, product lifecycle management
• Knowledge of critical aspects of BE studies and application in the oral solid dosage forms

The base salary for this position ranges from $115,000 to $130,000 per year.   Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting.  Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.  At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.  We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.

 

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.