Job description

Job Summary:

The R&D Sr. Scientist role is responsible for perform formulation and process development studies, generate documents, and scale up processes in support of ANDA or NDA filings. The technical expertise and process technology support can be used in problem solving as well as in continuous improvement activities. The R&D Sr. Scientist will work across the development/scale up/technical transfer projects. Working with subject matter experts, operation, and quality. R&D Sr. Scientist will be responsible for development/validation/investigation report with appropriate justifications, conclusion, and recommendations.

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Reporting Relationships*

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This position has no direct reports.

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Essential Functions: *

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Plan, perform and direct development activities for new products. Drive and monitor operational performance.

• Coordinate development activities for each drug product with the respective departments.
• Provide technical expertise and guidance for troubleshooting & problem-solving activities related to process and product investigations.
• Perform activities related to the formulation and process scale-up activities. Identify & select the appropriate ingredient required for use in new product development and perform scientific review for specification of raw materials and coordinate with suppliers as appropriate.
• Oversee manufacture of products using production equipment, such as batches for ANDA submissions, bioequivalence studies, and/or process scale-up.
• Provide technical support of ongoing manufacturing for new and currently produced products at the site.
• Work proactively with QA, Manufacturing, and other groups and coordinate/manage manufacture of registration/bio, validation, and initial commercial batches.
• Review and prepare master manufacturing batch records and process characterization protocols/ cleaning protocol using MACO calculation.
• Develop components of the product development report, process development report, and process parameter justification reports.
• Use advanced mathematical tools to develop in accordance with acceptable QbD.
• Maintain knowledge pertaining to cGMP documents and guidance, other regulatory guidance and GMP SOPs and comply with company standard operating procedures and currently accepted practices to assure product quality, safety, and efficacy.
• Support preparation of CMC documentation for the FDA and other international regulatory submissions. Assist in getting ready for pre-approval inspection (PAI).

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Specialized Skills and Knowledge: *

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Education/Certifications: *

• B.S. in Pharmaceutical Science or related discipline plus a minimum of 6 years’ experience.
• M.S. in Pharmaceutical Science with 4 years of experience.
• Ph.D. in Pharmaceutical Science with 2 years of experience.

• Indirect supervision, mentoring, and negotiating skills.
• Experience having developed and filled ANDA and NDA
• Knowledge of Technical techniques to evaluate formulations, immediate and modified release dosage forms, technology transfer methodologies, or advanced unit operations.
• Area of specialization at least 5 years’ experience.

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Key Competencies: *

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These are the skills, traits, qualities or characteristics that contribute to a person’s ability to perform responsibilities in an organization. Examples include but are not limited to: decision making, collaboration, leadership, communication, problem solving, adaptability and initiative. You must list the three most critical competencies._

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1. *Knowledge of the overall drug development and commercialization process from development, launch and through life cycle management
2. Working Excellent managerial skills; including project management, problem-solving, written and verbal communications, and organizational abilities.
3. Hands-on formulation research and development as well as formulation scale-up experience is desired, knowledge of US FDA registration guidelines.
4. Good team player and self-starter, innovative and comfortable in a multi-disciplinary team under defined timelines.

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Physical Demands/Factors: *

This position is primarily sedentary in nature. The employee may be required to lift up to 25 lbs.

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The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions._

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At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you quality for a reasonable accommodation based on a sincerely held religious belief or medical need._

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Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements._

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Avet is proud to be an Equal Opportunity Employer.*

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This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.*

Job Type: Full-time

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