QC Senior Associate Scientist - Method Transfer and Validation

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients.By being part of our team, you play a crucial role in maintaining this high standard and making a difference in the lives of patients.

The resource will work on-site at the Pfizer, Sanford, North Carolina facility and will be a member of Pfizer’s Quality Control Portfolio Management team to support multiple quality programs. You will be able to perform chemical, or biological or microbiological analysis on products. The colleague should be able to perform the analytical or chemical or microbial and sterility testing in the GMP laboratory setting and should be able to collaborate efficiently with the external teams. Additionally, the candidate should be able to document all the data to in accordance with cGMP and data integrity principles.

Also, should be able to review the validation data as a second analyst reviewer. Ensures that quality control procedures adequately evaluate an organization's products. Determines if current methods and techniques result in meeting reliability standards or require modification. (More concerned with standards, methods and procedures than with testing devices and equipment used to check products). Devises testing plans, methods and equipment to assure reliability of product in conjunction with product design and specifications. (More concerned with tests and quality control checks during and after product preparation.) Tests and inspects products to determine compliance with specifications. Include on- and off-line inspection. Performs laboratory tests on finished products, raw materials, and in-process material in support of the company's quality control program. Prepares reports and/or exercises administrative control in support of the company's quality control program.

What You Will Achieve

• Will apply knowledge from significant experience of applying the principles, concepts, and practices of a discipline.

• Be recognized as a significant technical contributor

• Increasingly rely on own experience and knowledge as well as that of others for scientific judgment in the work situation.

• Work in less structured problem-solving situations within own work group.

• Use established procedures, technologies, and methodologies. Frequently reduce to practice novel approaches.

• Work under moderate supervision with regular review of achievement of results and methods used. Plan and execute laboratory experiments with minimum guidance.

• Collaborate with trainers, colleagues and subject matter experts to perform the assays in the laboratories, including the use of computational predictive tools, modeling software, and data visualization tools as necessary.

• Assist teams in completing the assays required for the validation and transfer of methods.

• Engage with the method development team and participate in both in-process and final product sample analyses.

• Author relevant sections of technical reports to support interdepartmental technology and method validation and transfer processes.

• Prepare technical reports, critically review data as second analyst for the validations, and evaluate new instrumentation and analytical techniques as required

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 experience in manufacturing, quality, or engineering within the biotech or pharmaceutical industry.

• Solid understanding of aseptic laboratory techniques and quality systems.

• Proficiency in laboratory information management systems and data analysis software.

• Extensive hands-on experience and strong background in any or few of the following molecular biology assays such as Bioburden, endotoxin, spread plate bioburden, sterility, suitability and Purity.

• Experience with troubleshooting assays and improving method performance.

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

• Experience with bio-process downstream development.

Bonus Points If You Have (Preferred Requirements)