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Associate Lead Investigator

Employer
Pfizer
Location
Andover, Massachusetts
Start date
Sep 27, 2022
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Job Details

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The Andover Site Production Operations Team is looking for an individual to fill an Associate Lead Investigator Position within the Investigations group. The Andover Site Investigation group is responsible for overseeing investigations for all GMP manufacturing suites in Andover, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacture. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. This position will report to the Investigations Team Manager.

The candidate will be responsible for performing thorough, detailed and timely investigations and for the generation of high-quality investigation reports.

The individual will be expected to develop collaborative relationships with the operations, laboratory, quality, and other supporting groups in order to facilitate investigations using continuous improvement techniques. The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of GMPs. Experience with and in depth understanding of cell culture and chromatography is highly desirable. The candidate will be expected to assist in continually defining and improving the philosophy tools for investigations to meet changing business needs.

Additional responsibilities and expectations include:

  • Have a fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues

  • Have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceuticals. Be able to use that knowledge to investigate process deviations and atypical results.

  • Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards

  • Ability to coordinate and facilitate meetings, lead conversations, and influence teams

  • Exercise positive communication techniques to maintain relationships and gain consensus in group scenarios with multiple stakeholders.

  • Promote adherence to root cause analysis and human error reduction tools

How You Will Achieve It

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

  • Perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.

  • Ensure Quality Management System for the investigations department are followed and maintained.

  • Conduct and write formal investigation reports with the assistance of plant personnel and oversight from manager.

  • Coordinate and direct product disposition in accordance to agreed targets and procedures to meet business needs.

  • Conduct or participate in major investigations and as required.

Qualifications

Must-Have

  • High School Diploma with 4-6 years relevant experience

  • Bachelor's Degree (preferably in Science or Engineering discipline) with 1-3 years relevant experience

  • Master's Degree (preferably in Science or Engineering discipline) with 0-2 years relevant experience

Nice-to-Have

  • Experience in a pharmaceutical/biological manufacturing and/or laboratory operations

  • Technical background in a cGMP and Quality environment

  • Experience in leading investigations and project teams

  • Experience with deviation management systems

  • Experience in applying lean six sigma principles and continuous improvement methodology

PHYSICAL/MENTAL REQUIREMENTS

This position will require time in a production, warehouse or laboratory environment. Must be able to wear the appropriate PPE.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel may be required.

PHYSICAL/MENTAL REQUIREMENTS

This position will require time in a production, warehouse or laboratory environment. Must be able to wear the appropriate PPE.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel may be required.


Work Location Assignment:Flexible

Relocation assistance may be available based on business needs and/or eligibility.

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.

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.

Quality Assurance and Control

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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