Associate Director, Analytical Sciences

Summary:

The Associate Director is responsible for leading all analytical activities for one or more projects. This position manages GMP analytical studies as well as authoring/reviewing of CMC sections for regulatory submissions. The position will work closely with the CMC lead as well as other functional leads to ensure the project deliverables are met. The individual should be an effective mentor with strong leadership skills.

Essential Duties and Responsibilities

• Leads analytical activities for both drug substance and drug product for one or more projects
• Interacts with CMOs/CROs as well as internal inter-disciplines to ensure timely delivery of the analytical data
• Manages project specific resources including internal and external analytical personnel
• Summarizes experimental findings, reviews and interprets study results, assembles analytical data packages. Prepares and reviews development reports, assisting in the preparation of regulatory submissions
• Selects CMOs/CROs and manages outsourced GLP/GMP studies within Analytical Sciences
• Resolves highly technical issues, review deviation events and failure investigations at contractor sites in coordination with internal and external, quality assurance, and regulatory groups, as appropriate. Provide technical leadership for OOS and OOT investigations
• Identify and recommend analytical methodologies to support chemical development, formulation development, release and stability testing
• Author analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions
• Manages method development, validation activities, and sample testing in support of all ongoing development activity
• Supervises and mentors junior scientists
• Resolves complex method development challenges
• Reviews and approves analytical data, technical protocols/reports, specifications and analytical methods
• Monitors, organizes and prioritizes resources to increase efficiency on a regular basis
• Implements and supports efficient approaches in using and improving the systems within Analytical Sciences
• Maintains up-to-date knowledge of applicable industry and regulatory guidelines
• Authors and reviews SOPs
• Recruits, manages, trains and mentors Analytical Sciences staff, particularly with respect to new processes and procedures as well as changes in processes and systems

JOB QUALIFICATION

SEducation, Certifications, Experience

• Ph.D. in Analytical Chemistry or related disciplines with 11 years relevant industry experience, or BS/MS with 13 years of experience in the pharmaceutical/ biotechnology industry
• Excellent writing skills and extensive experience in CMC regulatory filings
• Proven management experience in the selection, supervision, evaluation and development of employees

Knowledge, Skills and Abilities

• Strong working knowledge of current Good Manufacturing Practices (cGMP)
• Able to manage multiple projects, effectively organizing and prioritizing tasks to achieve deadlines while rapidly adapting to changing program needs
• Demonstrated knowledge of all phases of drug development, strong experience in analytical methods development, CRO/CMO management and leading tech transfer
• Analysis and interpretation of analytical data
• Able to summarize and present data to stakeholders and drive decisions
• A very good understanding and knowledge of US and international (ICH) regulatory requirement
• Strong written and verbal (presentation) communication skills

SPECIAL WORKING CONDITIONS

Office environment / Domestic and International travel up to 25% may be necessary

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.

This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:

Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/careers-culture/who-we-are/