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62350282 BTx Co-Dev RFT Facilitator - Madison, NJ

Job Information

ID :
#37262545
# of Positions :
1
Minimum Education Level :
Bachelor's Degree
Experience Required :
5+ years
Duration :
Full Time Regular
Shift :
Unspecified
Hours per week:
40

Job Description

 

Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, technology and engineering are vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.
What You Will Achieve
This is a pivotal role in ensuring the success of new product portfolio with increasing complexity and challenges of accelerated programs with a high level of leadership and influence on the direction of Quality by Design (QBD) and Continuous Improvement. The individual will provide leadership and facilitation support to the co-development Bios network and will ensure that the biologic co-development portfolio consistently applies QBD principles in the areas of risk management, knowledge management, control strategy development and process understanding as part of the Technology Excellence function in PGS Global Technology & Engineering.
The position will be matrixed into the Right First Time (RFT) Program Office to manage the bios portfolio and ensure that the risk assessment approach is consistently applied across both PGS and Pharm Sci and continuously improved throughout the product lifecycle.
The candidate will support the Biologics Co-Development DP project teams and workflows to enable successful Tech Transfers and the creation of robust commercial manufacturing processes for Pfizer's pharmaceutical products. The role requires engagement with Bio-therapeutics Pharmaceutical Sciences (Pharm Sci), PGS, GCMC and quality leadership to provide RFT/QBD leadership appropriate to stakeholder needs. The position requires strong leadership, facilitation and interpersonal skills and effective written and verbal communication skills with subject matter experts, site technical colleagues, co-dev teams and governance teams.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
This position requires the candidate to be able to develop and refine business workflows and utilize risk-based tools to accomplish strategic objectives
The position requires experience with delivering training and educating colleagues on Pfizer's QBD approach, PGS RA programs, as well as providing leadership, guidance/consulting for new products. A comprehensive understanding of the principles of Quality Risk Management (QRM), risk assessment processes and Pfizer knowledge management practices is required.
Manage the Bios co-dev portfolio with a focus on DP
Support the Bios commercial transfer portfolio for DS and DP
Experience in developing control strategies for filings is ideal but not a requirement
Support select Bios marketed product and Bios business development products in application of co-dev RFT approaches
Ensure strong and consistent application of knowledge management related to RFT, specifically PUP and use of Pharma Investigator (PI) during co-dev RFT
Support continuous improvement of KM tools namely PUP and PI ensuring alignment between PGS and Pharm Sci through the Knowledge Domains
Qualifications
Must-Have
Bachelor's Degree
5+ years of experience
Demonstrated leadership, management and technical capabilities
Experience of coordinating and leading multi-disciplined, matrix teams
Proven project management, analytical, problem solving skills
Understanding of biological / vaccine requirements
Strong written and verbal communication skills
Has demonstrated capability to work independently on most assignments
Nice-to-Have
Master's degree
Relevant pharmaceutical experience
Practical experience in facilitating and conducting risk assessments
Drug Product and Drug Substance development and/or manufacturing experience

PHYSICAL/MENTAL REQUIREMENTS
N/A

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Approximately 20% travel may be required

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Engineering

\#LI-PFE

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.

Company Information

Name :
Description :
Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

We have a leading portfolio of products and medicines that support wellness and prevention, as well as treatment and cures for diseases across a broad range of therapeutic areas; and we have an industry-leading pipeline of promising new products that have the potential to challenge some of the most feared diseases of our time, like Alzheimer's disease and cancer.

To ensure we can continue to deliver on our commitments to the patients, customers and shareholders who rely on us, we are focused on improving the way we do business; on operating with transparency in everything we do; and on listening to the views of all of the people involved in health care decisions. Through working in partnership with everyone from patients to health care providers and managed care organizations to world governments and non-governmental organizations, our goal is to ensure that people everywhere have access to innovative treatments and quality health care.


Type :
Direct Employer
Address :
235 East 42nd Street
New York, NY 10017

Application Information

Online :
Job Posting Entered On :
1/5/2022
Job Posting Expires On :
4/5/2022