Vice President, Biologics
Exton, PA (Corporate)
- Client interaction and influencing the external scientific and regulatory environment are significant components of this role. Scientific and regulatory leadership within the Frontage Bioanalytical services organization. Responsible for the overall operations of the large-molecule bioanalytical activities.
- Be required to effectively communicate and interface with business partners, internal Quality Assurance Unit and external regulatory authorities in order to fully comply with GLP and other pertinent regulations.
- Establish and maintain business relationship with the clients. Develop and maintain high level of scientific achievements for the company. Be expected to be major contact for project coordination, including email and video/teleconference with customers. Consult with clients on drug discovery or development needs and establish appropriate immunochemistry assays or programs.
- Prepare, review or approve assay validation and bioanalytical reports and present study data to clients or in the scientific conferences.
- Provide training and mentorship to internal staffs. Initiate, plan and implement staff development programs.
- Develop and execute a strategic plan which identifies the areas in which the department will concentrate its scientific efforts, capital, and staff to meet growth objectives.
Qualifications & Education Requirements:
- PhD. or other scientific degree in pharmaceutical sciences, immunology, biology or a related field
- Minimum of 12 years of industrial experience in assay development for large molecules quantitation in support of PK/TK/PD, immunogenicity, and vaccine studies
- Familiar with pharmaceutical R&D process
- Demonstrate capability and confidence to build, train and lead a group
- Hands-on experience with ligand binding and cell-based assay in support ofbiologics and vaccine development in GLP environment. Biacore, Luminex, MSD, etc.
- Experiences with working in a CRO or with CROStrong interest and demonstrated skills with state-of-art equipment such as Gyros,
- Good interpersonal communication skills; excellent oral and written English