Senior Director, Analytical Sciences
Senior Director, Analytical Sciences
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1 Vacancy
Job Description
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 $225000 to $245000. 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 Consumer Privacy Act (CCPA) Notice for California Residents:
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Required Experience:
Exec
Employment Type
Full Time
