Gene Therapy 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

The Gene Therapy Lead Investigator provides investigational and continuous improvement support for G ene Therapy Operations. The position leads and/or participates in the investigational processes for deviations utilizing 6 Sigma (DMAIC) principles. This includes root causes identification, assessment of corrective actions and preventive actions (CAPAs), drafting complete investigation reports and interacting with regulatory authorities during audits. At a minimum, the position should be able to execute work independently, work with various groups across the organization and be able to lead investigations utilizing operational excellence tools and techniques.

As a Gene Therapy Lead Investigator , your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams. It is your hard work and commitment that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of complex projects and manage own time to meet agreed targets.
• Perform, lead and review deviation investigation reports, change control and validation/qualification.
• Provide direct input or coaching support for other functional groups in investigations.
• Manage investigations and apply relevant and necessary actions/ systems to ensure appropriate levels of compliance.
• Support regulatory audits through the preparation, defense and interaction with auditors for requested investigations.
• Provide expertise for trouble-shooting and resolution of issues related to business processes, equipment, facilities, utilities and human performance.
• Identify and implement investigational best practices to continuously improve the site performance.
• Represent Operations on site or network teams as necessary.
• The position requires execution and management of multiple initiatives at the same time and good communication skills to keep customers, peers, and area management up-to-date with progress of all such efforts

Qualifications

Must-Have

• Bachelor's Degree with 3+ years' experience
• Proven record of problem solving, decision-making skills and application of process improvement tools
• Experience in pharmaceutical industry
• Strong background and knowledge in manufacturing, compliance and technology investigations, processes and systems
• Must be comfortable working both independently and collaboratively
• Effective communication skills are required, both written and verbal
• Computer literate, with superior skills in managing Excel spreadsheets

Nice-to-Have

• Master's degree
• Experience with investigations, including conducting and writing investigations, using methodology

PHYSICAL/MENTAL REQUIREMENTS

Position requirements are typical for an office-based work environment with some shop floor exposure. There are no unusual physical or mental requirements for this position.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Schedule is primarily day shift (M-F, 8 hrs) but may require off-shift work on occasions. The position may require working on the floor in manufacturing or utility areas at times which will require a focus on safety. Aseptic gowning could be required.

• Last Date to Apply for Job: December 16, 2020
• Eligible for Employee Referral Bonus
• Eligible for Relocation Package

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