Use Your Power for PurposeThe 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 AchieveIn this role, you will:Authoring and reviewing GMP documents and reportsOverseeing qualifications, assessing period of use and managing extension of reference materialsSupporting change control, reagent study and instrument validation, as well as fulfilling commitmentsAuthoring periodic review of method validations and annual product reviews.Managing method improvement, new technology implementation and lifecycle activitiesFacilitating and performing method qualifications / validations / verifications, method transfers, and comparability studiesProviding audit support for Board of Health inspections and regulatory responsesEnsuring adherence to timelines and deliverables to support product manufacturingIdentifying continued improvement (CI) opportunities, resolving technical issues and monitoring the methods of productsParticipating in investigations / root cause analysis and resolution regarding analytical issuesCollaborating across functional areas and other Pfizer Biotech Network sitesHere 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 experienceProficiency in handling current MS Office ApplicationsExcellent written and verbal communication skillsStrong interpersonal abilitiesSolid understanding of US, EU, and ROW cGMP & GLP and auditing proceduresPossesses an in-depth understanding of protein characterization and production processes.Has prior experience in method improvement, including designing studies to enhance method robustnessDisplays 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 managementValidation experienceExperience in laboratory automationExperience with project management tools, including stakeholder managementStrong problem-solving skillsAbility to work collaboratively in a team environmentExcellent organizational and time management skillsExperience in a leadership role within a laboratory settingKnowledge of regulatory requirements and quality standardsAbility to mentor and develop junior team membersExperience 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 REQUIREMENTSNormal 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.Other Job Details:Work Location Assignment: Hybrid The annual base salary for this position ranges from $82,700.00 to $137,900.00. 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 to support each of life’s moments. Benefits offered include 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer.U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. 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If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Quality Assurance and Control