Scientist, QC Portfolio Management

Use Your Power for Purpose

At Pfizer, every day is an opportunity to make a difference in patients' lives. Your contributions will directly impact patient care, as you work within a flexible, innovative, and customer-oriented culture rooted in science and risk-based compliance. By joining our team, you will help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

What You Will Achieve

In this role, you will:

• Manage time effectively, develop short-term work plans, and work under limited supervision with periodic review

• Receive instructions on complex problems and report issues to management, participating in issue resolution

• Provide mentoring within the work group/project team, train junior colleagues, develop training plans, and oversee training activities

• Perform tasks associated with maintaining Current Good Manufacturing Practices (GxP) compliant Quality Control and Stability laboratories

• Represent Quality Control Analytical in cross-functional and site product meetings and provide subject matter expertise for standard operating procedures and quality standards content

• Interpret data, make recommendations, reach decisions based on data and management input, and review and approve environmental monitoring data

• Apply existing techniques and procedures with recommendations, implement modifications for improved efficiency, and devise and develop new microbiological methods

• Support change controls, investigations, and other technical documents, participate in regulatory filing writing, and determine environmental monitoring locations and qualification requirements for aseptic facility modifications and new facilities

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelor's degree with at least 2 years of experience; OR a Master's degree with 0+ years of experience; OR an Associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

• Demonstrated Subject Matter Expert level technical expertise on icIEF and CE- SDS techniques.

• Proven track record of independently accomplishing complex analytical method development and validation

• Proven track record of independently accomplishing complex analytical method validation.

• Experience with troubleshooting assays and improving method performance.

Bonus Points If You Have (Preferred Requirements)

• Strong background in leading continuous improvement projects

• Demonstrated expertise in defending laboratory practices during regulatory audits

• Proficient in organic chemistry, particularly in understanding the degradation mechanisms of pharmaceutical active ingredients and products

• Experience in environmental testing, utility monitoring, analytical testing, microbial identification, and sterility testing

• Expertise in Quality Control instruments and meeting accuracy specifications against established standards.

• Ability to set requirements for the transfer of methodology from R&D

• Experience with method validation and method transfer skills to manufacturing site.

• Experience with bio-process downstream development

  

Physical/Mental Requirements

• Resource is expected to be self-motivated and driven and able to manage day to day work activities with minimum direction.

• Should have a positive and teamwork mindset.

• Should be an analytical thinker and use their skills to troubleshoot the daily challenges faced at the workbenches, in data reviewing and documentation.

• Should be able to lift or handle up to 25 lbs containers

• Excellent written and verbal communication skills

• Strong interpersonal abilities

Non-Standard Work Schedule, Travel, or Environment Requirements

• This role is standard day Monday through Friday work shift: 8-5PM Onsite.

Other Job Details:

• Last day to Apply: October 27th

• Eligible for Relocation Assistance: No

• Work Location Assignment: On Premise.

The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and t