Our client is a clinical-stage biotech company founded by industry veterans and backed by leading venture capital funds. The company is focused on the development of novel cell-based cancer therapies using proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

Reporting into the Vice President, Protein Sciences the role will provide scientific and technical leadership for several programs at various stages of a protein therapeutic drug development including analytical method assessment, development, transfer, validation and troubleshooting of methods. As a member of the team, this individual will be responsible for the design and hands-on execution (as required) of analytical studies to support characterization, comparability, forced degradation, formulation development, and other developments activities of bio therapeutics protein drug candidates at all stages of clinical development.

Activities may be performed internally or with external vendors. Other responsibilities will include cross-functional team membership, authoring and/or reviewing method validation protocols and reports, technical reports, and supporting CMC aspects of regulatory dossiers.

Key Responsibilities:

• Support early stage, and late stage products in analytical sciences

• Analytical method development, validation, transfer and stability evaluations

• Vendor management and oversight of workflow as required

• Trouble-shooting of analytical methods

• Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences

• Author and/or review technical reports, test procedures, validation protocols and reports, and relevant sections of regulatory filings

• Support and ensure a smooth transfer of analytical technologies to contract sites

• Keep current with developments in analytical methodologies and make recommendations for implementation of new methods/equipment.

Key Attributes:

• Broad experience in analytical sciences supporting early stage, late stage products

• Direct experience with analytical method development, characterization, validation, transfer and stability evaluations

• Familiarity with additional biophysical techniques used in protein characterization is required.

• A comprehensive understanding of quality attributes, and protein degradation mechanisms as they relate to drug substance and drug product development and quality.

• Demonstrated technical proficiency of analytical methodologies for drug substance and drug product

• Experience in regulatory requirements for pharmaceutical products

• Experience in managing contract analytical organizations is mandatory

• Demonstrates potential for technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills, including ability to lead and drive performance of cross-functional teams.

• Excellent written and verbal communication skills with ability to multi-task.

• Demonstrated troubleshooting and problem solving skills

Quality System Requirements:

• Current knowledge of quality systems and both FDA and EU regulations as they relate to process / product development and manufacturing

Qualifications and Experience:

• Advanced degree in Chemistry, Pharm. Sci., Biochemistry, or related field, or equivalent combination of education and work-related experience required

• >10 years direct experience analytical development, preferably in a Pharmaceutical/biotech industry