Job Description
General Description
The Fellow Scientist, Pharmaceutical Technologies will be responsible for formulation development and optimization projects at Biovire. The Fellow Scientist will conduct research and design experiments to develop new product formulations and improve existing ones.
Additionally, the Fellow Scientist will act as a Formulation and Process Development Subject Matter Expert for the Biovire site, collaborating with Business Development and Process Development teams to support New Product Introduction.
The role requires a strong focus on quality, implementation of best practices, and continuous improvement.
DUTIES AND RESPONSIBILITIES
The Fellow Scientist is responsible for all Formulation Development activities for New Product Introduction, supporting Process Development and Business Development as the Subject Matter Expert.
Essential Duties and Responsibilities:
1. Adhere to current Good Laboratory Practices (GLPs), Good Manufacturing Practices (GMPs), company policies, quality standards, and regulatory requirements.
2. Serve as the technical lead for formulation development studies, including designing experiments, data analysis, and characterization for new and existing formulations.
3. Support manufacturing and project schedules to ensure timely delivery of milestones.
4. Promote safe work habits, ensuring a clean and safe workplace.
5. Maintain quality standards and best practices throughout manufacturing.
6. Collaborate with Business Development to develop project proposals for formulation activities.
7. Support ongoing New Product Introduction activities with the Pharmaceutical Technologies group, including process optimization and risk assessment.
8. Create, review, and update SOPs, Master Plans, and Study Protocols related to formulation development.
9. Use manufacturing knowledge to revise and improve procedures and processes.
10. Maintain positive relationships with manufacturing teams and support functions.
Behavioral Expectations:
1. Strong work ethic and ability to work independently.
2. Lead by example to foster a collaborative culture.
3. Excellent interpersonal and communication skills.
4. Proficient in Microsoft Office applications.
5. Strong organizational and mathematical skills.
6. High integrity and commitment to ethical standards.
7. Respectful and courteous in interactions.
8. Ownership and accountability for production schedules and product quality.
9. Knowledge of cGMP and regulatory principles.
Work Experience and Education Requirements
* Minimum of 10 years' experience in the pharmaceutical, biologic, or medical device industries.
* Bachelor's degree in Biology, Chemistry, or related Life Sciences.
* Graduate degree in Chemistry, Biochemistry, Molecular Biology, or related field is preferred.
* Employment contingent upon a successful background check.
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