Scientist IV, Product Support
PfizerAbout the role
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
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. Key responsibilities include:
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
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
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.
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 and method transfer experience
Experience in laboratory automation
Experience in statistical analysis
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.
Work Location Assignment: Hybrid
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s