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 QUALIFICATIONS
- 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.
- 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 requirements
- Strong written and verbal (presentation) communication skills.
- Office environment / Domestic travel up to 10% 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.The expected salary range for this position is $185,000 to $200,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. 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/
California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com, because Controller wishes to evaluate your candidacy for employment at Controller.Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller’s Privacy team can be contacted at privacy@gossamerbio.com.
Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.
