Scientist IV, Product Support

Pfizer • Andover, MA

1d • Hybrid

About The Position

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. The qualified candidate will deliver technical support for biotherapeutic products within Quality Control Product Technical Support group in Andover, MA. Applicants with proven organizational and communication abilities as well as comprehensive expertise and hands-on experience in pertinent analytical methodologies are strongly encouraged to apply. 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.

Requirements

• BA/BS with at least 6 years of experience or MBA/MS with at least 4 years of experience
• Exhibits strong communication skills and proficiency in technical writing.
• Shows initiative, the capacity for independent work, and flexibility in adapting to dynamic project demands.
• Displays extensive knowledge in protein analysis techniques, including HPLC/UPLC, peptide mapping, CE/gel, ICE, and UV.
• Has prior experience in method improvement, including designing studies to enhance method robustness.
• Possesses an in-depth understanding of protein characterization and production processes.
• Displays knowledge of cGMP standards and auditing procedures.

Nice To Haves

• Experience with ELISA and bioassay methodologies is considered advantageous.
• Knowledge of industry standards and ICH, and applicable guidelines in validation and life cycle management
• Validation and method transfer experience
• Experience in laboratory automation
• Experience in statistical analysis

Responsibilities

• 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.
• Supporting continued process verification (CPV) of the products
• 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

Benefits

• A 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 to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees