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Director, GTx Operations Lead


Sanford, NC
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Job Details

Job Title Director, GTx Operations Lead

JobID 1048800-1852

Location: Sanford, NC

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

Operations leader of new PGS Gene Therapy Facility (potential future expansion for Cell Therapy in future) to be located in Sanford, NC. Position will initially be focused on start-up of the facility and partnering with BTx PharmSci to deliver clinical supply for Gene Therapy assets.Includes responsibilities to establish an operational structure and hiring plan, lead point of contact with Global Engineering project team to provide operational input on final design, equipment selection and construction of the new facility, and defining operational procedures & practices to meet unique needs of Pfizer's first Gene Therapy facility intended to manufacture clinical and commercial GTx products 'end to end' (DS, DP, and pack & label) as well as defining clear interface model and appropriate alignment with main Sanford site and support functions. Aligned with main Sanford site, the new GTx Operations lead will be responsible for managing through multiple layers and multiple teams of a cGMP manufacturing operation that emphasizes safety and right the first time manufacturing. Ensures and accountable for compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practice regulations (cGMP), product licenses, corporate policies and safety practices. Responsible for budget and staffing levels, performance evaluation, salary recommendations and career development of all individuals within multiple functional areas.


Start-up of new PGS Gene Therapy Facility in Sanford, NC*BackgroundoPlanning for staged investment, with Stage 1 project kicking off in March 2017. Stage 1 will be a retrofit of existing unused space in Building 101 into 5 Drug Substance manufacturing suites and a DP suite and pack & label operations, as well as potential the rebuild of analytical lab to support release/stability testing GTx productsoIntention to leverage general site services from Sanford facility (i.e. maintenance) for Stage 1oGMP readiness of new facility by end 2018 is critical to several priority projects for PfizeroThis new facility will be Pfizer's first clinical and commercial GTx facilities. Unique needs and standards for late stage/commercial facilities in GTx space are still evolving, and Pfizer wants to leverage our history of biotech manufacturing experience to influence and lead in this area*New GTx Operations Leader will be lead point of contact with Global Engineering and core member of the project teamoProvide operational input on final design, equipment selection and construction of new facilityoResponsible for operability of new facilityoPartner w/ GE Project lead to develop integrated project schedule from design to operational/GMP readinessoMutually responsible with GE Project lead for delivering on start-up schedule*Responsibility of GTx Operations Leader to establish an operational structure and hiring plan for the new PGS GTx facility (Stage 1) oPartner w/ BTx Pharm Sci to leverage learnings from their clinical operations both in GTx (Bamboo, Chapel Hill) as well as JJ Pilot PlantoPartner w/ PGS Grange Castle (SSF), GTS-Puurs (S2F2), and GTS-Hangzhou (China) to leverage PGS's most recent experiences with start-up of small scale clinical/launch facilities, as well as learnings in new facilities that are highly leveraging use of disposablesoDefine hiring plan and training strategy to meet accelerated timeline, including proposals to optimally leverage new operations staff during construction and qualification/commissioning phase.oDefine operational structure and strategy to optimally support multi-suite / multi-product operations, including start-up strategy for priority assets*Responsibility of GTx Operations Leader to define operational procedures & practices to meet unique needs of Pfizer's first GTx facility for manufacture of both clinical and commercial products, as well as defining clear interface model and appropriate alignment with main Sanford site and support functions*Responsibility of GTx Operations Leader to establish a cost competitive operating structureAct member and contributor on the new PGS Gene & Cell Therapy (G&CTx) matrix team*Partner with other G&CTx leads in PGS and other key partner / stakeholder groups (i.e. BTx PharmSci, Reg CMC, etc.), Specifically,oWork with G&CTx QO lead to define any unique needs from operational perspective for future quality organizationoWork with G&CTx ES lead to leverage learnings from external partners (i.e. facilities, operational strategies), and contribute into development of vendor strategies for unique raw materials and components*Leverage power of full PGS organization into the G&CTx space*Identify solutions and proposals to address unique opportunities and challenges in GTx space, both in operations and cross-functional (e.g. COGS optimization; PV strategies bridging across "duplicate" manufacturing suites, viral reduction strategy, etc.) *Establish longer term strategy for future transition back into the main Sanford site operations upon commercialization of initial assetsOngoing responsibilities of GTx Operations Lead*Organizational Leadership- Directs efforts of multiple assigned staffs in GTx clinical manufacture in compliance with evolving cGMP's and company procedures. Control of schedules and priorities*Compliance and Quality - Assures cGMP compliance and safety compliance for all processes and colleagues during the production operations. Reviews investigations of deviations of processes and makes product disposition recommendations. Directs staff in the writing / revising of procedures and SOP's to ensure compliant operations. Assure readiness for BOH inspections*Process Improvements - Provides input and implements strategic direction for product and process improvement. Leads site groups that support existing production and future production of new products. Focus on continuous improvements to support Quality, Supply, and Value of products.*Facilities - Plans and implements site strategies for both the short-term maintenance and long-term acquisition of equipment. Supports the implementation of network-wide systems*Financial - Provides input on operating budgets for labor, material, and capital expenditures. Responsible for creating department budget and adhering to budget.*Talent management - Coaches, develops, and counsels colleagues on a timely basis regarding behaviors, skills, and career opportunities to form a high performance team.


Minimum of a B.S. in Biochemistry, Chemical Engineering or related science with at least 15 years of biotech manufacturing and/or parenteral product development and/or manufacturing experience, including 8 years of direct supervisory and managerial level experience. Master's degree is preferred. Experience in two of the following areas is required: Manufacturing, Materials Management/Planning, QA, QC, Technical Services, and/or Engineering. Experience and skill in business management and finance. Experience with Pfizer budget processes including managing project budgets preferred.Understanding of biological and aseptic CMC and product development requirements.Ability to quickly understand the operating principles and risks of new technologies. Ability to develop, coach and motivate colleagues, including long term goals and vision for a new operating team. Demonstrated ability to plan and allocate resources, and to manage changes in resource allocation in response to evolving business needs.Demonstrated leadership skills in delivering results within project timelines through others. Experience in problem-solving, negotiations, presentation and supervision of a multi-layered organization, including understanding of DAMIC (six sigma) tools and practices, and a focus on continuous improvementEffective written and verbal communication skills.Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situationsStrong interpersonal skills and experience working in a team environment across business functions.Independent, self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.Position supports a 24/7 manufacturing operation. Some overtime may be required including some infrequent weekend work. Some travel may be required on an infrequent basis as well.on standard work schedule

*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.

*Director, GTx Operations Lead*
*Sanford, North Carolina*

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