Lead Investigator

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

You will help us in investigation of our quality issues in manufacturing and quality laboratories. You will investigate deviations and out-of-specification results and atypical result investigations. Your problem solving skills will help to identify root cause and suggest appropriate corrective action plan. Your attention to detail will help us ensure that the reports are aligned to regulatory requirements and company policies.

Role Summary:

The Sanford Site Investigations Team is looking for an individual to fill a Lead Investigator Position within the Investigations group. The Site Investigation group is responsible for overseeing investigations for all GMP manufacturing suites in Sanford, 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.

How You Will Achieve This

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

• Work under limited supervision, with the ability to problem solve, manage priorities, and make decisions independently.

• Drive/contribute to the completion of complex projects and take responsibility for a portion of the team’s milestones/deliverables.

• 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

BASIC QUALIFICATIONS

• Bachelor's Degree (preferably in Science or Engineering discipline) with 3-6 years relevant experience

• Master's Degree (preferably in Science or Engineering discipline) with 2-5 years relevant experience

PREFERRED QUALIFICATIONS

• Demonstrated experience in a pharmaceutical/biological manufacturing and/or laboratory operations

• Demonstrated technical background in a cGMP and Quality environment

• Demonstrated experience in leading investigations and cross-functional project teams

• Demonstrated 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.

Additional Information:

• Last day to apply: May 18, 2022

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.