Job Summary
The Senior Director of Analytical Sciences will provide the leadership to integrate and oversee all aspects of analytical activities in support of new drug substance and new drug product development, manufacturing, and stability. This individual will be responsible for implementation of stage-appropriate analytical strategies to support drug substance and drug product manufacture of preclinical, clinical, registrational, and commercial batches across the portfolio.
Essential Duties and Responsibilities
- Lead a team of analytical scientists to design and execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of material specifications, reference standard characterization, and product characterization.
- Ensure analytical timelines and objectives are clear and communicated across line functions.
- Develop a scalable analytical function providing strategic input into department structure.
- Partner with CROs/CMOs to manage activities related to analytical method development, optimization, troubleshooting, qualification/validation, and characterization activities for starting materials, process intermediates, drug substances, and drug products.
- Develop, build and maintain strong relationships with vendors and service providers.
- Represent Analytical Sciences function in management team meetings and participate in cross-functional development teams as needed.
- Support CMC due diligence for in-licensing and development of product IP opportunities.
- Responsible for financial accounting and expenditures for AS activities across projects
- Provide input and recommendations on departmental policies, procedures, resourcing, budgets and goals.
- Ensure alignment of analytical strategies with health authority and regulatory requirements
- Support analytical line lead function in CMC teams and interdepartmental meetings.
- Ensure EHS and compliance training for the analytical function.
JOB QUALIFICATIONS
- PhD in Analytical Chemistry or related discipline with 15+ years relevant industry experience, or BS/MS with 17+ years relevant experience in the pharmaceutical/ biotechnology industry.
- Proven experience in the recruitment, selection, management, supervision, evaluation and development of employees.
- Demonstrated knowledge of drug development, CMO/CRO management, manufacturing, and regulatory CMC for development and commercial stage programs.
- Working knowledge of current Good Manufacturing Practices (cGMP) requirements.
- Strong writing skills and extensive experience in CMC regulatory filings.
- Extensive experience preparing and updating regulatory filings (IND, NDA, MAA).
- Excellent written and verbal communication skills.
- Able to effectively organize and prioritize tasks to achieve established deadlines.
- Able to multi-task and adapt rapidly to changing business and program requirements.
- Demonstrated ability to work on multiple projects and meet timelines.
- Knowledge of current US and international regulatory requirements.
- 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.The expected salary range for this position is $225,000 to $245,000. 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/
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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.
