Scientist - Method Transfer and Validation

Employer
Pfizer
Location
Sanford, North Carolina
Posted
Oct 12, 2021
Ref
4827545
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 at Sanford, NC. Key responsibilities in QC Method Transfer and Validation (MTV) are performing tasks/activities associated with analytical method qualification, validation, verification and transfer. Specific activities include authoring/executing/review of study design, protocols and reports associated with analytical method qualification/validation/transfer to support Pfizer’s quality programs. You will be responsible for participating in laboratories’ readiness for routine testing of but not limited to, Demo, Engineering, CTM (Clinical Trial Material), product/process validation and commercial batches manufactured at Pfizer. Additional responsibilities will include driving continuous improvement/Operational Excellence/innovative implementations; represent QC MTV on cross functional teams; and providing guidance/training/coaching to junior colleagues; troubleshooting.

The individual should be able to demonstrate the following:

  • acting safely, knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely
  • recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards 
  • excellent effective written and verbal communication and interpersonal skills; established relationships within business lines
  • ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues
  • applies discipline’s principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals
  • solving highly complex mathematical problems and situation dependent problems using convoluted information
  • method 1, yellow belt trained and can apply tools to solve issues (including technical issues)
  • ability to receive feedback from management and other colleagues, takes accountability for actions and personal development
  • consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail-oriented behavior
  • good judgment and correct decision making based on Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network
  • represents Quality Control on site and network teams/forums that support sustaining or improving site or network operations; influences and negotiates with business lines and shares information obtained with team; acts as change agent for improvements
  • proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule
  • delivery on high business impact projects/activities/changes
  • able to holistically review and authorize all laboratory data, and have an extensive overall knowledge of all laboratory operations
  • able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records; assist with protocol non-conformance evaluations
  • able to identify and seek out external resources (e.g. PDA, ISPE) to build or enhance understanding of scientific discipline; supports training of staff; mentoring and coaching junior colleagues
  • displays strong investigative or technological orientation with independence for design of projects/studies and able to make significant independent contributions to the development of methodology including new technologies and automation
  • expertise with investigations quality system and able to independently handle complex investigations and associated CAPA within own work area under limited guidance

Individual should have knowledge of US, EU, and ROW cGMP; pharmacopeias; ICH guidelines; analytical chemistry and/or Microbiology techniques and instrumentation; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM  application); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.

Qualifications

Must-Have

  • Bachelor's Degree
  • 5-7 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
  • 2-4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field
  • 1-2 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Ph.D. in Science/related field
  • Demonstrated experience in Quality Control
  • Good knowledge of analytical method validation
  • Good knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques.
  • Reasoning ability including strong analytical and problem-solving abilities
  • Strong verbal and written communication skills

Nice-to-Have

  • Master's degree
  • Experience with a wide range of analytical techniques, analytical testing and use of analytical equipment: i.e. UV-VIS, HPLC, UPLC, PCR, plate-based assays, IEF, etc
  • Experience in Analytical method validation and transfer
  • Experience supporting Change Control Assessments
  • Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

Other Job Details:

  • Last Date to Apply for Job: October 26, 2021
  • Eligible for Employee Referral Bonus: 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.

Quality Assurance and Control

#LI-PFE