Principal Scientist, Regulated Bioanalytical

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Closing date
Jul 2, 2022

View more

Sector
Science, Pharmaceutical
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
Role Summary

The successful candidate will join an industry leading Regulated Bioanalytical group to support biotherapeutic projects in the portfolio pipeline. Responsibilities include managing activities required to maintain regulatory compliance of multiple assay platforms (e.g. ligand binding, cell-based, PCR) utilized for the measurement of drug concentration, immunogenicity, and vector/transgene biodistribution in various biological matrices. With deep knowledge of both the bioanalytical discipline and regulatory guidance (GLP, GCLP), the successful candidate will be an active team member driving the overall quality and compliance of the Regulated Bioanalytical group.

Responsibilities
  • Oversee quality and compliance of the Regulated Bioanalytical (Reg BA) group to maintain high level of regulatory compliance and inspection readiness.
  • Work in close collaboration with bioanalytical quality management (BQM) leadership on optimization and implementation of quality and compliance infrastructure.
  • Acquire deep knowledge of departmental processes and system applications to conduct in-depth quality control (QC) and compliance reviews of study data and documentation generated for the assay development, validation, and implementation of robust and reliable assays per department SOPs and regulatory guidance.
  • GLP and GCP study reviews to include all aspects of the sample life cycle from receipt through final disposition per department SOPs and GLP/GCLP guidelines.
  • Mentor bioanalytical staff on comprehensive study documentation and corrective and preventative actions (CAPA) strategy.
  • Organize and drive successful routine internal audits and external inspections.
  • Work in close collaboration with departmental management and Quality Assurance to manage CAPA.
  • Lead continuous process improvement with regular monitoring and review of compliance metrics and CAPA with Reg BA group.
  • Perform reviews with a high degree of independence and under challenging timelines to support project deliverables.
  • Support activities for oversight of regulated infrastructures (QC, sample coordination, and instrument validation and maintenance).


Basic Qualifications
  • BSc with 9+ or MSc with 6+ years or PhD with 3+ years relevant experience
  • Background working in GLP, GCLP environment is required.
  • Expertise across multiple assay platforms (ligand binding, cell based, PCR).
  • Demonstrated track record as a study bioanalytical principal investigator with knowledge of assay development and validations supporting biotherapeutics.
  • Experience in QC and investigation of quality events and CAPA process.
  • Direct experience with inspection readiness and audit conduct of regulated bioanalytical laboratory.
  • A detail-oriented, self-motivated individual with flexible approach and team-oriented work style will be critical to the success of the candidate.
  • Ability to excel in a collaborative, fast paced and dynamic environment is essential.
  • Excellent organizational and communication skills.


Preferred Qualifications
  • Experience outsourcing regulated bioanalytical support to external vendors is a plus.
  • Knowledge of hybrid and/or nanoflow LCMS biomarker assays.


Other Job Details
  • Eligible for Employee Referral: YES
  • Eligible for Relocation Assistance: YES


#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Research and Development

#LI-PFE

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert