Scientist IV, Product Support

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
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.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer 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 [email protected] . 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.
Quality Assurance and Control