Analytical Lead, External Manufacturing Science & Technology
The Role
Accountable for the execution of assigned programs in Analytical development in External Manufacturing. Responsible for leading cross-functional teams from technical perspective to ensure operational excellence/quality in the design, execution and completion of assigned program activities from technical aspect.
Role And Responsibilities
- Manage cross-functional teams from technical perspective to ensure operational excellence/quality in the design, execution and completion of assigned program activities.
- Lead Analytical development for drug substance.
- Ensure compliance with latest GMP regulations (ICH, FDA, EMA and PMDA).
Required Qualifications
- Experience in pharmaceutical research & development.
- Technical expertise in analytical development related activities.
- BS/MS or Ph.D in a life science or relevant field.
- Experience managing external CRO/CMOs.
- Good communication and logical thinking skills.
Preferred Qualifications
- 10+ years working in pharma or relevant industry.
- Experience with Project Management, budget estimation and tracking of task execution.
- Working knowledge of the latest GMP regulations (ICH, FDA, EMA and PMDA).
Location and Working Environment
This position is hybrid and based in Northbrook, Illinois. At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver.
Pay
Salary Range: $105,280 - $150,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
Benefits
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Company fleet vehicle for eligible positions
- Referral bonus program