Scientist IV, Product Support
Pfizer, S.A. de C.V, Andover, MA, United States
What You Will Achieve
The qualified candidate will deliver technical support for biotherapeutic products within the 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, collaborating with cross‑functional teams, providing analytical support of products and processes, assisting with regulatory submissions/response, and 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 reviews 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 transfer, 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 continuous improvement 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, 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.
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.
Compensation and Benefits
Annual base salary range: $82,700–$137,900. Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of base salary.
Benefits include 401(k) with matching contributions, retirement savings contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
EEO & Employment Eligibility
Pfizer is committed to equal opportunity and complies with all nondiscrimination laws and work authorization requirements. This position requires permanent work authorization in the United States.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws. Licensed physicians may have recruiting expenses reimbursed reported under the Sunshine Act. Contact Talent Acquisition with questions.
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The qualified candidate will deliver technical support for biotherapeutic products within the 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, collaborating with cross‑functional teams, providing analytical support of products and processes, assisting with regulatory submissions/response, and 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 reviews 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 transfer, 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 continuous improvement 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, 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.
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.
Compensation and Benefits
Annual base salary range: $82,700–$137,900. Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of base salary.
Benefits include 401(k) with matching contributions, retirement savings contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
EEO & Employment Eligibility
Pfizer is committed to equal opportunity and complies with all nondiscrimination laws and work authorization requirements. This position requires permanent work authorization in the United States.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws. Licensed physicians may have recruiting expenses reimbursed reported under the Sunshine Act. Contact Talent Acquisition with questions.
#J-18808-Ljbffr