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Job Details


Pfizer: One of the World's Premier Biopharmaceutical Companies

Quality Control Cell-Based Assay Scientist III

Pharmaceuticals

All

Full Time

On Site

No

Andover, Massachusetts, United States

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 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 R&D.

As a Scientist, your deep knowledge in the discipline, will make you an active team member who influences at the project team level. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.

It is your knowledge and skills that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Contribute to achievement of goals at the work group/ project team level as a full team participant.
  • Perform tasks associated with maintaining {Current} Good Manufacturing Practices {part of GxP} compliant Quality Control and Stability laboratories.
  • Represent Quality Control Analytical in cross functional and site product meetings.
  • Interpret data and make recommendations and reach decisions based on data and management input.
  • Apply existing techniques and procedures, with recommendations, and implementation of modifications for improved efficiency, or devise and develop new microbiological Reporting issues to management and participating in issue resolution.
  • Train junior colleagues, develop training plans and oversee training activities for groups.
  • Provide subject matter expertise for standard operating procedures and quality standards content, as well as providing gap analysis to ensure that the environmental monitoring program is compliant with all regulatory requirements.
  • Support change controls, investigations and other technical documents.
  • Participate in regulatory filing writing in sections related to analytical method and stability testing.
  • Determine environmental monitoring locations and qualification requirements for aseptic facility modifications and new facilities.
  • Conduct and review non-conformance investigations related to aseptic manufacturing.
  • Review and approval of environmental monitoring data and approval of data in Laboratory Information Management System for lot release.
Qualifications

Must-Have
  • Bachelor's Degree
  • 4+ years' experience
  • Demonstrated experience in industrial and/or aseptic pharmaceutical production environment, technical knowledge of aseptic processing and sanitization
  • Cell based assay experience
  • Demonstrated independent accomplishment of complex analytical method development and validation
  • Ability to receive feedback and takes accountability for actions and personal development
  • Excellent effective written and verbal communication and interpersonal skills
  • Basic computer skills, such as data entry, with a high level of attention to detail, are also required
Nice-to-Have
  • Master's degree and 2+ years of relevant experience
  • Flow cytometry experience
  • Experience leading continuous improvement projects
  • Experience defending laboratory practices in regulatory audit.
  • Experience with electronic laboratory information management systems such as LabWare LIMS
  • Working knowledge of organic chemistry, including degradation mechanisms of pharmaceutical active ingredients and pharmaceutical products

PHYSICAL/MENTAL REQUIREMENTS

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

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.

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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