Fellow Scientist, Pharmaceutical Technologies

General Description

The Fellow Scientist, Pharmaceutical Technologies will be responsible for formulation development and formulation optimization projects at Biovire. The Fellow Scientist will conduct research and design experiments to develop new product formulations and improve existing product formulations.

Additionally, the Fellow Scientist will act as a Formulation and Process Development Subject Matter expert for the Biovire site, collaborating with Biovire Business Development and Process Development team to support New Product Introduction at the Biovire site.

The role requires strong focus on driving quality into production processes, implementation of best practices, and continuous improvement.

DUTIES AND RESPONSIBILITIES

The Fellow Scientist is responsible for all Formulation Development activities for New Product Introduction, and supports Process Development and Business Development groups as Subject Matter Exper for New Product Introduction.

Essential Duties and Responsibilities:

1. Adherence to current Good Laboratory Pracities (GLP's), Good Manufacturing Practices (GMP's), company policies, Quality standards, and regulatory requirements

2. Technical lead for Formulation Development studies, design of experiments, data analysis and characeterization for new formulation development and existing formulation optimization.

3. Support the manufacturing schedule and project schedule from a formulation development standpoint, to ensure on-time delivery of project milestones to our customers

4. Practice and promote safe work habits, ensuring a clean, safe workplace for personnel.

5. Ensure quality standards and best practices are maintained throughout the manufacturing process.

6. Collaborate with Biovire Business Development to develop appropriately scoped project proposals for formulation development activities.

7. Collaborate with Biovire Pharmaceutical Technologies group as scientific SME to support ongoing New Product Introduction activities, including process optimization, characterization, risk assessment, and deviation investigation activities.

8. Create, review, and/or update Standard Operating Procedures (SOP's), Master Plans (Process Validation, Cleaning Validation, Containment, etc.), and Study Protocols in support of formulation development activities.

9. Utilize manufacturing knowledge and experience to revise and improve procedures and processes.

10. Maintain positive working relationships with manufacturing customers and manufacturing support functions

Behavioral Expectations:

1. Strong work ethic and ability to accomplish tasks without supervision.

2. Demonstrate leadership both by words and leading by example to foster Biovire One Team culture.

3. Excellent interpersonal skills with the ability to cooperate with others in a high-performance setting.

4. Basic computer skills (proficient in Microsoft Office applications).

5. Strong mathematical and organizational skills.

6. Excellent English communication skills, both written and verbal.

7. Must possess honesty and integrity, commitment to the highest legal and ethical standards.

8. Ability to treat every person with courtesy and respect.

9. Demonstrate ownership and accountability to production schedule without compromising product quality.

10. Knowledge of fundamental cGMP and regulatory principles.

WORK EXPERIENCE AND EDUCATION REQUIREMENTS

Minimum of 10 years' experience in the pharmaceutical, biologic or medical device industries.

Four-year degree in Biology, Chemistry, related Life Science, or equivalent.

Graduate degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, Biomedical Engineering, or a related Life Science is preferred.

Employment at Bryllan (Biovire) is contingent upon a successful Background check.