Scientist

Consistently performs routine and complex analytical chemistry activities with a degree of independence. Demonstrates technical expertise in one or more analytical areas. Performs chemical, in-vitro, or in-vivo biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, in-process samples, finished product, process & cleaning validation samples, package samples and components, as well as some specialized techniques. Assays are performed in compliance with USP, FDA, and other regulatory body requirements, Pfizer standard operating procedures, and approved license requirements.

Responsibilities

• Performs time-sensitive in-process testing in support of Operations, including OBE 5 drug products, which may require adjusting work hours as needed.
• Writes, reviews, and approves protocols, reports, and investigations associated with the laboratory and method validation activities.
• Compiles validation data into comprehensive reports.
• Works on analytical methods in support of new product launches and existing marketed products.
• Applies creative ability and specialized scientific knowledge to solve marketed product analytical problems or evaluate changes.
• Evaluates and implements new measurement technologies to improve sensitivity, selectivity, and/or the ability to characterize excipients, in-process materials, and finished products.
• Participates in laboratory investigations, creates Change Control, revises test methods, writes protocols, and performs approvals.
• Ensures analytical measurements are accurate and methods comply with FDA and other regulatory agency guidelines, cGMP, and corporate requirements.
• Conducts assays and analyzes results independently, utilizing Laboratory Information Management Systems (LIMS) where applicable.
• Develops problem-solving skills and makes tactical decisions based on results.
• Trains and mentors analysts in new and existing procedures, techniques, and governmental regulations.
• Plans and executes tasks to achieve routine goals, seeking advice from management for priority conflicts.
• Maintains all related records, prepares media, buffers, reagents, and keeps the work area orderly.
• Assists in coordinating testing activities of the group.
• Contributes to the development of new technologies, revising methods and procedures to ensure compliance with applicable regulations.
• Carries out technical and administrative duties as assigned.

Requirements

• BS/BA in Chemistry or Biochemistry, or an advanced degree preferred, with 6 years of experience; OR MBA/MS with 4 years of experience.
• 6 years of experience within Quality Control or other relevant analytical experience in the pharmaceutical industry.
• Experience with general lab equipment and equipment troubleshooting.
• Prior experience in the following areas:
  • Making sound and effective decisions under pressure.
  • Working with other manufacturing sites to understand broader perspectives.
  • Exposure to regulatory inspections, including direct interactions.
  • Effectively working within Quality Control and across network channels to accomplish goals.
• Knowledge of the following areas is critical:
  • ICH and other applicable industry standards.
  • Principles of Data Integrity.
• Ability to perform mathematical calculations and complex data analysis.

Organizational Relationships

Provides regular interaction with the following groups or key roles:

• Manufacturing: Work priorities, information sharing, discussion of problem batches, manufacturing/technical issues, deviations, and other events with potential impact on product quality and/or supply.
• Other Site Quality functions and site functions; Q&C OpU contacts: For any relevant topic, as appropriate.
• Site and Corporate Regulatory Affairs function: Change Control process; addressing and resolving potential issues with regulatory impact. Providing support for queries and BOH filings.
• Vendors, Contractors, and other 3rd parties: Interactions on any relevant Quality & Compliance issue, joint projects, and routine business contacts.
• Industry Committees, Trade Associations: Representation of Pfizer; information exchange and discussion of emerging regulations and regulatory expectations and their impact on the industry.

Pay

The annual base salary for this position ranges from $79,400.00 to $132,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary.

Benefits

• Comprehensive and generous benefits package, including:
  • 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
  • Paid vacation, holiday, and personal days.
  • Paid caregiver/parental and medical leave.
  • Health benefits, including medical, prescription drug, dental, and vision coverage.
• Relocation assistance may be available based on business needs and/or eligibility.

Schedule

Responsible for ensuring time-sensitive in-process lab testing is performed in support of Operations. This may require adjusting work hours as needed.