Lead Investigator - GMP Manufacturing

Lead Investigator - GMP Manufacturing 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. Responsibilities Responsible for performing thorough, detailed and timely investigations and for the generation of high-quality investigation reports Develop collaborative relationships with the operations, laboratory, quality, and other supporting groups in order to facilitate investigations using continuous improvement techniques Assist in continually defining and improving the philosophy tools for investigations to meet changing business needs Have a fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues Have a detailed understanding of the processes and systems involved in the manufacture of biopharmaceuticals. 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 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 Minimum Qualifications High School Diploma with a minimum of 10-15 years of relevant experience OR; Bachelor’s degree (preferably in a Science or Engineering discipline) with a minimum of 5-8 years relevant experience OR; Master’s degree (preferably in a Science or Engineering discipline) with a minimum of 3-6 years relevant experience Experience in the area of quality and compliance and a working knowledge of GMP Experience with and in-depth understanding of cell culture and chromatography is highly desirable Ability to coordinate and facilitate meetings, lead conversations, and influence teams Preferred Qualifications 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 Physical Requirements This position will require time in a production, warehouse or laboratory environment. Must be able to wear the appropriate PPE Location/Schedule This is a fully onsite role in Andover, MA Monday - Friday; 9 AM - 5 PM Contractor Note Please note contractors are engaged to provide services to Pfizer temporarily in connection with a specific assignment. Contractors are hired and employed through Atrium, our third‑party payrolling partner. Temporary Role Statement This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits, and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on several factors, including skills, competencies, experience, location and/or being pursued, and other job‑related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements. Pay Rate Range Min Pay Rate $98 Max Pay Rate $108 Currency USD Unit hourly Benefits Information Comprehensive Benefits Package available based on eligibility Short-Term Disability (STD) Long-Term Disability (LTD) Supplemental and Voluntary Life Insurance #J-18808-Ljbffr