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Sr. Manager, Gene & Cell Therapy Technical Support Team Lead


Sanford, NC
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Job Details

Job Title Sr. Manager, Gene & Cell Therapy Technical Support Team Lead

JobID 1615254

Location: Sanford, NC

Description **ROLE SUMMARY**

Gene & Cell Therapy Technical Support Team Lead responsible for transferring G&CTx products as well as providing technical support these products and interfacing with BioTx PharmSci. Position will initially be focused on the technology transfer of first two assets as part of start-up of the PGS GTx facility.

Includes responsibilities to establish and lead a technical support team to provide technical support for GTx Facility operations in Sanford, for the technology transfer of gene and cell therapy (G&CTx) assets into late stage pivotal and commercial facilities as the PGS lead (either internally into the new PGS GTx Facility and/or CMOs), and to establish and drive application of the RFT Co-development processes for risk assessments and development of control strategies, as well as appropriate aspects of PGS's Zero Defect Transfer (ZDT) process for G&CTx assets as they are transferred into the PGS internal and external network. Additionally, this role will be responsible to define the interface model and appropriate alignment with key stakeholders, including the Global Engineering Project Team (during capital project/start-up phase), GTx Operations, Co-development teams (and/or PharmSci Project Teams if an early stage program), BioTx PharmSci SMEs, Regulatory CMC, WRD Global Supply Chain (and external clinical packaging & labelling CROs) as well as supporting functions within Sanford site (i.e. QC/laboratory services, warehouse, logistics, finance, etc.).

Responsible for budget and staffing levels, performance evaluation, salary recommendations and career development of all individuals within new G&CTx Technical Support team after it is established.


Enable accelerated start-up of Stage 1 GTx Facility in Sanford, NC including technology transfer and delivering initial late stage clinical supply for lead assets

• Collaborate with current Global Engineering Project Team, growing GTx Operations Team, and product specific project teams (i.e. CDT/PSPT) to define specific tech transfer strategies and execute to meet accelerated delivery targets for CTM of priority assets

• Support and lead worksteams of the Operational Readiness Plan as agreed with GTx Operations Lead

Establishment of new G&CTx Technology transfer model and G&CTx Technical Support Team (estimate 3-6 direct reports)

• New G&CTx TS Team Lead will be responsible to define and drive "fit for purpose" application of RFT process (i.e. risk assessments), and ZDT for gene & cell therapy products moving into PGS internal and/or external site

o Establish generic templates, pre-work and expectations for RA0, RA1, etc... and future planning toward Control Strategies for these new modalities working with Control Strategy EWG, BTx and Co-Dev teams

o Drive learnings and consistency on tech transfer and RFT between G&CTx project / project teams

o Primary RFT RA facilitator for G&CTx projects moving into Co-Dev

• Responsibility of G&CTx TS Team Leader to establish new G&CTx TS Team

o Define staffing level and hiring plans, to support accelerated start-up plan (Stag1) and "steady state" vision for team

o Partner w/ BTx BRD support organization (i.e. Vector Core, ACMF, etc.), GTS-Puurs (S2F2), PGS ADCs and GTS-Hangzhou (China) to leverage learnings and best practices between technology transfer and process engineering functions

o Define organization structure and strategy to optimally provide necessary technical support to new PGS GTx Operations in Sanford as well as late stage assets at CMOs

• Responsibility of G&CTx TS Team lead to define interface model and appropriate alignment with key stakeholders, including the Global Engineering Project Team (during capital project/start-up phase), Co-development teams (and/or PharmSci Project Teams if an early stage program), GTx Operations, BioTx PharmSci SMEs, Regulatory CMC, WRD Global Supply Chain (and external clinical packaging & labelling CROs) as well as supporting functions within Sanford site (i.e. QC/laboratory services, warehouse, logistics, finance, etc.).

• Responsibility of G&CTx TS Team lead to establish operating budget for team, as well as individual project budgets

Act 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,

o Work with GTx Operations lead to define appropriate support model and interface points between Op's and PE teams

o Work with G&CTx QO lead to define any unique needs from technical and product perspective for future quality organization

o Work with G&CTx ES lead to leverage learnings from external partners (i.e. validation, control strategies, etc.), 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 technology transfer for start-up and providing day to day technical support, as well as well more proactive/strategic areas (e.g. COGS optimization; PV strategies, comparability, etc.)


+ 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 direct supervisory and managerial level experience. Master's degree is preferred.

+ Experience in two of the following areas is required: Manufacturing, QA, QC, Technical Services, and/or Engineering.

+ Experience and skill in business / project management is preferred. Experience with Pfizer budget processes including managing project budgets preferred.

+ Experience in Pfizer large molecule / biologics Co-Development process(es). Familiarity with RFT for co-development, including Pharma Investigator is preferred.

+ Experience in start-up of new operational facility 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 improvement

+ Effective written and verbal communication skills.

+ Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations

+ Strong 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 off hours work may be required including some infrequent weekend work (especially during project phase). Travel may be required (10-20%)

**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.

**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.

+ **Last Date to Apply for Job: 3 November, 2017**

+ **This job is (Pfizer) (Exempt) (US/PR) Grade: 014**

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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