1+ months

Senior Lead Investigator

Pfizer
Andover, MA 01810
**ROLE SUMMARY**

The Andover Site Production Operations Team is looking for an individual to fill a Senior 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. As a senior level position within the Site Investigation group the responsibilities of this position will be multi-faceted. They include serving as the primary lead investigator on complex investigations related to all production operations, laboratory, and production support areas. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. In addition, this position will be responsible for assisting the manager of investigations in transforming the investigation process on site including development and implementation of continuous improvement techniques. Duties of this position may also include coaching and mentoring to staff members to enable them to meet their established timelines, work commitments and further their professional development. This position will report to the Investigations Team Manager.



**ROLE RESPONSIBILITIES**

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.

+ Act as Subject Matter Expert for the Investigations group, mentoring and providing guidance to other colleagues.

+ 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**



+ High School Diploma with 10-15 years relevant experience **OR**

+ Bachelor's degree with 6-10 years relevant experience **OR**

+ Master's degree with 5-8 years relevant experience



**PREFERRED QUALIFICATIONS**



+ Science or Engineering field of study preferred

+ Demonstrated expertise in pharmaceutical/biological manufacturing and/or laboratory operations

+ Strong technical background in a cGMP and Quality environment

+ Significant experience in leading complex investigations and cross-functional project teams

+ Versed in navigating deviation management systems and business processes

+ Demonstrated knowledge and application of lean six sigma principles and continuous improvement methodology



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Position is first shift Monday through Friday. Flexibility to work outside of regularly schedule shift may be required to support business needs.

+ 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.



**Other Job Details:**



+ Eligible for Relocation Assistance: NO

+ Eligible for Employee Referral Bonus: YES



\#LI-PFE



**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

Categories

Posted: 2021-02-24 Expires: 2021-05-09

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Senior Lead Investigator

Pfizer
Andover, MA 01810

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