Pfizer Manager New Product Quality in Lake Forest, Illinois
Hospira, a Pfizer company, is the global leader of injectable drugs and infusion technologies, committed to putting patients first by improving access and care worldwide.
Supporting the Pfizer Essential Health business unit (formerly Pfizer's Global Established Pharmaceutical (GEP) organization) the Manager of New Product Quality will be responsible for supporting and delivering on assigned programs in the Pfizer Essential Health Portfolio. Responsible for quality oversight of the development and enhancement of new and existing assets of the Pfizer Essential Health portfolio. As the quality representative responsible for representing Pfizer Global Supply, this individual will be the quality resource assigned to the development teams responsible for the development and commercialization of generic injectable products, biosimilar pharmaceuticals, anti-infectives and global expansion of commercial assets. Additionally, he or she will, identify development program risks pertinent to quality and compliance, working to resolve risks or liaise with partners in quality to drive resolution/mitigation throughout the entire development lifecycle of a program or asset (product). The development lifecycle is defined as starting with concept and ending with the commercial launch of the product.
During the product development lifecycle, they will oversee quality attributes related to characterization, specification development, formulation process definition, identification of critical process parameters and critical quality attributes.
Key responsibilities for the role include but are not limited to: technology transfer, execution registration batches, clinical batch manufacturing, support for clinical activity, stability, development investigations and identification of CA/PA, supplier and contract manufacturing organization qualification and management during development lifecycle, Pre-Approval Inspection Readiness for both internal and external suppliers, analytical method transfer and risk assessment of both processes and products.
This position will be located at one the following Pfizer locations:
Melbourne, Australia Groton, Connecticut Sandwich, UK St. Louis, Missouri Andover, Massachusetts Lake Forest, Illinois McPherson, Kansas
Development program core-team member responsible for quality oversight to ensure procedures and specifications for Active Pharmaceutical Ingredient (APIs)/Drug Substance (DS), excipients, finished products/Drug Product (DP), filters, packaging materials, etc. and their respective suppliers, both internal and external, are in alignment with Pfizer Quality Standards, BoH, ICH, compendia requirements and the regulatory submission for the product.
Demonstrated ability to support multiple programs while driving identification and mitigation of quality related development issues.
Quality peer-review of regulatory submissions and response to agency inquiries.
Ability to clearly articulate areas of concern and communicate in written and verbal means to various levels of management. Excellent written and communication skills required to document and facilitate success within the role.
Ability to work in a matrix environment, across lines of management, and use situational leadership to collaborate with functional partners.
Develop a task / deliverable outline for molecule with detailed oversight of the following areas at a minimum (Assessment / Remediation / Execution planning / QP process / Test Method Transfer) to drive timely completion and escalate potential delays or missed deliverables to management.
Engaging in team activities to incorporate quality and awareness at all levels ensuring all quality deliverables are timely preventing delays in submissions and / or launches. Responsible to support equipment or manufacturing investigations in support of process improvements.
Manager will be responsible for providing quality support, leadership and oversight for 5-10 active programs at any given time.
Minimum of 5 years of experience within the pharmaceutical industry. Experience in R&D, Aseptic and/or Biopharmaceutical manufacturing is preferred.
Bachelor's degree in science (biology, biochemistry, chemistry or physical sciences) recommended. Advanced degree in science or business is preferred.
Expertise in cGxPs (manufacturing, clinical, laboratory or development), regulatory and board of health requirements.
Expertise in product development, technology transfer, method transfer, and aseptic/biopharmaceutical manufacturing technologies and requirements with product launch and, as required, commercial support.
Sitting, typing and viewing a computer monitor for long periods of time.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
International and domestic travel necessary to facilitate success within the role. (Travel estimated 10%)
Due to global nature of role and international development centers, team meetings may be required outside of normal business hours of 9AM-5PM.
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.
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.
Last Date to Apply for Job: 6/4/2018
Additional Location Information: Lake Forest, IL United States
Eligible for Relocation Package
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.