| Job Description | VaxInnate Corporation, a small biotech company focusing on developing protein based vaccines for infectious diseases, is currently seeking a Senior Manager/ Manager for the Formulations Department in our Cranbury, NJ facility. He/ she will lead a team in developing and testing protein formulations for VaxInnate’s vaccine candidates. All of VaxInnate’s vaccine candidates are fusion proteins administered via injection. We seek an experienced biopharm manager to help us develop suitable and stable formulations for our preclinical and clinical vaccine candidates. The candidate must have a strong managerial background in a biopharm environment and have experience developing or leading the development of protein parenteral formulations.
Primary Requirements:
* Manage one or more formulation scientists to meet the goals of the department
* Conceive and execute formulation development strategy for parenteral protein preparations from bench scale feasibility studies through process development, batch production, scale-up studies and technology transfer to commercial production;
* Design and execute experimental programs to develop robust and cost effective Phase I through Phase III clinical protein formulations to meet regulatory and safety expectations
* Lead formulation and stability programs using internal and external resources, interact with multidisciplinary teams and outside vendors
* Identify key characteristics of vaccine candidates using HPLC, CD, DLS, IF, etc... to guide formulation activities
* Support formulation development for process development intermediates
* Analyze data and report outcomes using scientific approaches
* Accurately report technical information and the status of process development at project team meetings, group meetings and in monthly reports
* Lead outsourced cGMP filling operations for clinical candidates
* Maintain a current understanding of protein formulation as related to GLPs and GMPs
* Support formulation of animal study preparations
* Train other team members and new employees as required
* Abide by all applicable safety policies
Position Requirements:
* B.S., M.S. or PhD degree in a scientific discipline
* At least 7 years hands on formulations experience with parenteral protein preparations, with at least 4 years managerial or supervisory experience. Position level will be determined by relevant experience.
* Demonstrated leadership and project management skills
* Superior oral and written communication skills
* Experience running, developing methods, and analyzing data for HPLC, DLS, DSC, CD, and other suitable protein characterization assays
* Familiarity with DOE and associated software
Addition Position Considerations:
* Prepared regulatory documents such as IND or BLA
* Considered a subject matter expert in protein formulations
* Experience in planning and executing cGMP production campaigns for recombinant proteins |
| | Company | | VaxInnate Corporation | Job Code | | State or Province | | New Jersey | | |
|
