Scientist IV, Product Support Full-time

Use Your Power for Purpose

The qualified candidate will provide technical support for biotherapeutic products within Quality Control Product Technical Support in Andover, MA. Qualified candidate will have proven organizational and communication skills as well as comprehensive expertise, including hands-on in relevant analytical technologies. In this role, you will be responsible for managing and facilitating analytical activities throughout the lifecycles of biological products. This involves collaborating with cross-functional teams to achieve site objectives, providing analytical support of products and processes, assisting with regulatory submissions and responses, as well as authoring and reviewing technical documentation.

What You Will Achieve

In this role, you will:

• Authoring and reviewing GMP documents and reports
• Overseeing qualifications, assessing period of use and managing extension of reference materials
• Supporting change control, reagent study and instrument validation, as well as fulfilling commitments
• Authoring periodic review of method validations and annual product reviews.
• Managing method improvement, new technology implementation and lifecycle activities
• Facilitating and performing method qualifications / validations / verifications, method transfers, and comparability studies
• Providing audit support for Board of Health inspections and regulatory responses
• Ensuring adherence to timelines and deliverables to support product manufacturing
• Identifying continued improvement (CI) opportunities, resolving technical issues and monitoring the methods of products
• Participating in investigations / root cause analysis and resolution regarding analytical issues
• Collaborating across functional areas and other Pfizer Biotech Network sites

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 6 years of experience or MBA/MS with at least 4 years of experience or PhD/JD with any years of experience
• Proficiency in handling current MS Office Applications
• Excellent written and verbal communication skills
• Strong interpersonal abilities
• Solid understanding of US, EU, and ROW cGMP & GLP and auditing procedures
• Possesses an in-depth understanding of protein characterization and production processes.
• Has prior experience in method improvement, including designing studies to enhance method robustness
• Displays extensive knowledge in protein analysis techniques, including HPLC/UPLC, peptide mapping, CE/gel, carbo analysis, ICE, and UV.
• Experience with ELISA and bioassay methodologies is considered advantageous.

Bonus Points If You Have (Preferred Requirements)

• Knowledge of industry standards and ICH, and applicable guidelines in validation and life cycle management
• Validation experience
• Experience in laboratory automation
• Experience with project management tools, including stakeholder management
• Strong problem-solving skills
• Ability to work collaboratively in a team environment
• Excellent organizational and time management skills
• Experience in a leadership role within a laboratory setting
• Knowledge of regulatory requirements and quality standards
• Ability to mentor and develop junior team members
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

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.