Astellas Pharmaceutical Jobs

Job Information

Astellas Pharma Bioanalytical Senior Manager, PK 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 Bioanalytical Senior Manager, PK opportunity at their Astellas Research Institute of America (ARIA) site in Northbrook, IL.

Purpose:

Astellas is a Japanese-owned global pharmaceutical company focusing on drug development in Oncology, CNS, Anti-infectives, and other medical specialties globally. With its innovative pipeline, Astellas is developing new modern small and large molecule therapeutics, as well as new alternative modalities (i.e. viruses, cell therapy) in order to optimize patient health. This job position is to support and strengthen bioanalysis throughout the Astellas drug development pipeline, specifically in the areas of gene therapy and oncology.

The successful candidate would be accountable for regulated bioanalytical as clinical pharmacology, data sciences and stats. This effort would be under the supervisor's initial direction, but it is expected that the successful candidate would be self-motivated, able to manage multiple programs simultaneously, and can conduct job function independently.

Essential Job Responsibilities:

  • Manage outsourcing of large molecule pharmacokinetics and immunogenicity assay validation and clinical testing to qualified CROs and ensuring BLA regulatory compliance of testing executions.

  • Serve as a project manager for external assay development and validation and clinical testing to clinical studies (P0 through post-market obligations)

  • Past experience of outsourcing bioanalytical testing or working in a Contract Research Organization (CRO) is essential/critical, requiring full GCLP understanding.

  • In ccollaboration with clinical development teams, contribute to review of clinical trial protocols, informed consent forms, clinical study reports, and other regulatory documents.

  • Provide information and input on study timelines and deliverables. Provide technical expertise/guidance during CRO discussions or assay troubleshooting.

  • Serve as subject matter expert as needed for regulatory filings, FDA inspections, and audits for companies/academic institutions/CROs being considered or active for clinical development

  • Ensure data quality and integrity of validation and sample data.

Organizational Context:

  • This position reports to the Associate Director, Bioanalysis

  • Collaborates with multiple functions within Astellas Drug Discovery Research and Astellas Pharma Global Development in project development.

  • Active member in project core team, study team, and extended team meetings (in conjunction with Global Development group)

Qualifications:

Required:

  • Ph.D. in Molecular biology or biological sciences or equivalent with 5+ years of related experience; Master's degree with 8+ years, BS Degree with 12+ years of related experience.

  • Knowledge and experience with advanced methods in large molecule and cell/gene therapy pharmacokinetics and immunogenicity a must.

  • Understanding of critical reagent preparation and its characterization is a must.

  • Working knowledge of LBA and IGC bioanalytical method validation and sample analysis regulatory guidelines in all regions (FDA, EMA, PMDA, etc.)

  • Knowledge and experience in the validation of ligand binding, cell based and chromatography assays using ELISA, MSD, Lumenex, Gyros and Hybrid LC-MS

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

  • Must be able to work under strict or accelerated timelines and with deliverables.

  • Skilled in preparing and presenting scientific presentations and problem solving

  • Experience with regulatory agencies interaction is a plus

  • Participate in process improvements and develop best practices for bioanalytical function

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

  • Travel is <30%

  • Other relevant responsibilities as assigned

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

#LI-JA1

Category Research and Development

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

DirectEmployers