Astellas Pharmaceutical Jobs

Job Information

Astellas Pharma Manager, Bioanalysis in Northbrook, Illinois

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Astellas is announcing a Manager, Bioanalysis opportunity at their Astellas Research Institute of America (AIRA) site in Northbrook, IL.

Purpose:

The manager will develop and implement analytical methods for biomarker and other pharmacodynamic measurements (i.e. Genomics / Flow) within company's current pipeline with minimal supervision from the laboratory director. These assays are essential for clinical pharmacology and clinical studies required to get approval of new drugs. Ensure that clinical programs have a firm scientific foundation and that assessments contained within the clinical protocols have merit.

Essential Job Responsibilities:

  • Conduct bioanalytical method validation/ qualification work following the clinical protocol, SOPs and FDA guidance

  • Perform bioanalytical sample analysis for clinical studies remaining within current regulatory guidelines

  • Manage contracted work by CRO so that clinical timelines and requirements are met or exceeded.

  • Support regulatory submission to agencies for global submissions.

  • Provide guidance and potentially manage a direct report

  • Establish and maintain vendor relationships under Astellas' quality requirements

  • Other relevant responsibilities as assigned

Organizational Context:

  • This position reports to the Director of Bioanalysis. The individual will work closely with other members of the Bioanalysis staff and will interact with R&D, Drug Development and Translational Development groups.

Qualifications:

Required:

  • Ph.D. in Biological Sciences, Chemistry or equivalent with 3+ years of related experience; M.S. with 8+ years of related experience; or B.S. with 13+ years of related experience

  • Skills in conducting bioanalytical research especially for running clinical samples, documenting data, and assisting report writing following the regulatory requirements

  • Working knowledge of SOPs and GCLP regulatory guidance

  • Ability to transfer and validate methods

  • Knowledge of computer software for laboratory data management

  • Self-motivated, excellent team player with good communication skills

Preferred:

  • Knowledge and experience in one/ more of the therapeutic areas (oncology, inflammation, infectious diseases, neurosciences)

  • Knowledge of FDA guideline for bioanalytical method validation

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

  • Referral bonus program

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Category Research and Development

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

DirectEmployers