mRNA QC Manager

Employer
Pfizer
Location
Andover, Massachusetts
Posted
Jul 02, 2022
Ref
4855853
Discipline
Quality, Quality Control
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

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control (QC) instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from Research and Development (R&D).

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

The qualified candidate will provide oversight and management of a vaccine drug substance/drug product in a quality control lab. The oversight will include routine testing and meeting customer timelines. The manager will oversee investigations, trending and lab compliance. The position includes people leading, employee development, performance reviews and establishing training plans. The manager will help drive department goals, objectives and prioritization as well as collaborate on network teams to achieve product goals and objectives.

How You Will Achieve It
  • Ensuring product testing is completed on time for delivery to customers
  • Maintaining cGMP compliance and laboratory inspection readiness
  • Review and approval of documentation associated with cGMP testing, method validation, investigations, change controls, regulatory filings and technical reports
  • Coach, mentor and develop direct reports
  • Make decisions and set priorities related to product testing, deviations, investigations, projects, method validations and regulatory filings.
  • Assist with assay troubleshooting and problem solving.
  • Collaborate with colleagues and site functional areas to drive department and site goals and objectives
  • Develop a continuous improvement culture within the group and guide lab analysts on use of continuous improvement tools
  • Work with other managers to plan and optimize organizational structures, workload, staffing and budget for QC.
Qualifications

Must-Have
  • B.S. or M.S. in Biology, Chemistry or related scientific discipline
  • 5+ years' leadership/management experience
  • Demonstrated experience in Quality Control
  • Extensive knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques
  • Extensive knowledge and practical application of relevant analytical techniques for drug substance/drug product
  • Reasoning ability including strong analytical and problem solving abilities
  • Strong people management experience
  • Strong verbal and written communication skills
  • Proficiency with computer systems (Microsoft Office applications, LIMS, etc.)
Nice-to-Have
  • Master's degree
  • Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.


PHYSICAL/MENTAL REQUIREMENTS

Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (Laboratory).

Ability to perform mathematical calculations and to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.


Relocation support available

Work Location Assignment:Hybrid

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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