Manager/Team Lead, Bio-Analytical

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Jun 11, 2022
Ref
4856994
Required Education
Bachelors Degree
Position Type
Full time

Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

At Pfizer, you will play a critical role in Quality Operations. As a member of the team, you will help to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture on site in order to ensure compliance with Pfizer and Regulatory Authority expectations. You and your team serve as the primary point of contact for the investigation and resolution of all product quality issues discovered or originating in the Pfizer Country Office (PCO) and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, BU) and Pfizer Global Supply on such issues. Your role will also monitor the product quality and compliance activities at the PCO, to ensure current regulatory expectations are met and facilitate internal and regulatory GMP inspections.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

ROLE SUMMARY

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team by being a Team Leader of the Bioanalytical lab within our Sterilization Technology team while balancing day to day investigational responsibilities. You will be responsible for a group that conducts a variety of bioanalytical/immunological tests for our Active Pharmaceutical Ingredient and Drug Product plants to support our quality programs. The teams this role would lead performs: Potency Assays, Cytotoxicity Assays, SDS-Page, and multiple other bioanalytical tests. Your contribution to the bioanalytical in-process, release, stability, validation, and investigational testing program will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control (QC) instruments will help us meet product accuracy specifications against established standards.

As a Team Leader, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. You will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

ROLE RESPONSIBILITIES

  • Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.

  • Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

  • Review and approve documentation associated with Good Manufacturing Practices {also cGMP}, method validation, investigation of change controls and technical reports.

  • Collaborate with site functional areas and customers to support site goals, objectives and timelines.

  • Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight and work with other management teams to ensure support for all testing activities in the routine testing area.

  • Provide oversight of testing for the Bioanalytical Lab, assuring tests are performed in a cGMP manner, compliant with the latest regulatory and industry expectations.

  • Oversee project management of all Data Integrity related activities with the relevant teams.

  • Address and resolve any potential issues with regulatory impact.

  • Represent area of responsibility at meetingsand in audits.

  • Provide information, discuss problem batches, manufacturing/technical issues, deviations and other events with potential impact on product quality and/or supply.

  • Foster teamwork and colleague development, as well as change management, within the department and set up departmental metrics to achieve operation effectiveness.

BASIC QUALIFICATIONS

  • Bachelor's Degree in Immunology or related science.

  • 5+ years' experience.

  • 2 years people management experience.

  • Demonstrated experience in Quality Control/Quality Assurance.

  • Demonstrated experience in leading Pharmaceutical Industry Laboratory Investigations to proper root cause identification and resolution.

  • Extensive knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, application of compendial methods is a must.

  • In-depth understanding of bioanalytical testing techniques and procedures.

  • Demonstrated ability to develop, optimize and validate test methods.

  • Expertise with blood-based assays and demonstrated ability to work with international groups in order to transfer validated assays/Test Methods to labs located in USA and abroad.

  • Demonstrated ability to work with contracted manufacturers and perform audits of their testing and quality systems for compliance.

  • Reasoning ability including strong analytical and problem-solving abilities.

  • Strong people management experience.

  • Experience in leading a team of technicians and contractors to complete moderately complex testing.

  • Strong verbal and written communication skills.

PREFERRED QUALIFICATIONS

  • Bachelor’s degree in Immunology or related science and 12+ years’ experience.

  • Master’s degree in Immunology or related science and 10+ years’ experience.

  • Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

  • Experience with quality systems (PQS, QTS, eQMS, SQL-LIMS, GLIMS).

  • Direct experience with ATGAM, Coral Snake antivenom, and Thrombin testing procedures.

PHYSICAL/MENTAL REQUIREMENTS

  • Job requires sitting, standing, walking, and the ability to type

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is primarily 1st shift (8am-4:30pm). Additional hours before/after shift and occasionally on weekends is sometimes required for business needs and to be able to meet with labs in other countries


Work Location Assignment:Flexible

Other Job Details:

  • Last Date to Apply for Job: June 24, 2022

  • Eligible for Relocation Package

  • Eligible for Employee Referral Bonus

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.

Quality Assurance and Control

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