Executive Director Of Analytical Development - La Jolla, United States - Anaptysbio Inc

Description

AnaptysBio Inc
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Description:

Position Summary

We are looking for a highly talented and motivated Executive Director of Analytical Development to lead AnaptysBio Analytical and Quality Control groups that supports our platform and pipeline of monoclonal antibody therapies. The successful candidate will be responsible for ensuring successful development, GMP testing, and stability testing, and will coordinate method development, qualification, and validation. The individual will have in depth knowledge of Analytical methods used for in-process testing, release testing, stability testing, and product characterization. The candidate will work with our External Suppliers, Research, Technical Operations, and Quality to ensure scientific and information transfer occurs in a highly collaborative environment.

Essential Functions

• Serves as the technical and strategic expert in analytical method development for product attributes of monoclonal antibody therapies.
• Provides experienced leadership for mentoring staff and developing effective teams with high scientific standards.
• Provides technical leadership and subject matter expertise relating to product investigations.
• Establishes and manages work plans to achieve Analytical Development goals across all products.
• Analytical method development, transfer, and phase appropriate validation for release and stability testing, in-process analysis and starting materials and intermediate testing (as appropriate)
• Establishes product characterization, comparability strategies and plans in compliance with regulatory requirements.
• Departmental budgeting and resource management.
• Provides technical and GMP compliance guidance to cross functional teams in support of project goals.
• Represents the Analytical Development function for authoring, reviewing, and approval of GMP and regulatory documents as appropriate, including SOPs, protocols, reports, specifications, QTPPs, CQAs, risk and impact assessment, and filing sections.

Requirements:

Qualifications

Education & Experience:

• Advanced degree in a biological science, chemistry, or related life science with 15 years of relevant experience in biologics development including late-stage development (PhD preferred).
• Protein Analytical expertise developing analytical methods for the characterization of complex monoclonal antibodies.
• Fundamental knowledge in cell biology, immunology, cell culture, cell-based assays and assays standard to biologics product release and characterization.
• Breadth of knowledge across analytical method development, method validation, cGMP, Quality Systems and regulatory requirements for biologics.
• Demonstrated in-depth skills in designing, executing, interpreting and documenting experiments.
• Authoring analytical methods and characterization sections of CMC regulatory documents.
• Supervisory experience
• Demonstration of strong communication skills, leadership skills, and ability to effectively influence others.
• Role Model for AnaptysBio Values (Accountability, Humility, Transparency)

Knowledge and Competencies:

• Ability to work independently to execute strategic plans.
• Tracks budgets and escalates variances to senior management.
• Understanding of GMP/GLP regulations
• Ability to work with External Suppliers
• Open and transparent communication skills (verbal and written)
• Solid organizational and time management skills
• Project management skills and computer proficiency.
• Ability and willingness to travel 20% of the time (internationally and domestically).
• Knowledge of Analytical method and QC external suppliers and their skills and competencies.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

May be required to travel by plane or car.

This position requires working with biological and/or chemical hazards.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Compensation details: Yearly Salary

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