Senior Director, Gene Therapy Process Development
Location:
Durham , North Carolina
Posted:
October 22, 2017
Reference:
1148920060

POSITION DESCRIPTION The Senior Director, Gene Therapy Process Development (GTxPD) is accountable for overseeing and providing strategic and technical directions to the development of gene therapy processes for Pfizer's emerging portfolio of gene therapy products, including cell line development, culture and purification process development as well as technology transfer and process scale-up. To accomplish this, the position is responsible for establishing and maintaining an effective organization, ensuring that all the requisite scientific and technical resources, processes, and systems are in place to enable and deliver drug substance supply for clinical studies. The role serves as the single point of accountability for scientific, strategic and operational initiatives related to the development of clinical and commercial gene therapy processes supporting Pfizer's gene therapy portfolio. The individual will also be a key and integral member of the Bioprocess R&D leadership team. The Senior Director, Gene Therapy Process Development, is accountable for maintaining strong technical and collaborative interactions with other Bioprocess R&D and BioTherapeutics Pharmaceutical Sciences lines, as well as Rare Disease Research Unit (RDRU) and Pfizer Global Supply (PGS). ROLE RESPONSIBILITIES Provide strategic and technical leadership to the Gene Therapy Process Development Groups and to the Bioprocess R&D organization in development of robust, compliant and cost efficient processes to enable drug substance supply for clinical studies and product registration. Aspire to develop world leading gene therapy process technology and deliver clinical supplies faster, better, and less expensively than any of our competitors. Provide mature and experienced scientific perspectives with respect to cell and molecular biology, upstream and downstream process development as well as process scale-up required for gene therapy clinical and commercial process development. Ensure GTxPD aspects of the biotherapeutics pipeline tools are met and the portfolio is supported with the appropriate scientific and operational framework to ensure business success Works with appropriate internal and external partners to identify, prioritize and address critical GTxPD technical needs - implements innovative and impactful technical solutions and paradigms to proactively address future GTxPD needs Foster a culture of innovation and an environment of technical mastery on the part of colleagues at all levels and identifies ways to maximize the impact of the GTxPD organization Provides strategic oversight and identifies ways to maximize the value of the emerging gene therapy portfolio and gene therapy process technologies Serve as member of the Bioprocess R&D Provide subject matter expertise and strategic leadership to CMC efforts including regulatory submissions Collaborate with and work across other Pfizer Research and Business Units, Business Development and any other external partnership as well as Pfizer Global Supply to facilitate gene therapy portfolio program progress Engages external industry technical leaders / innovation centers and advocacy groups to influence / lead industry and regulatory directions in the gene therapy process development space Construct and manage organizational design that matches strategy with structure Understand large group dynamics and how to effectuate interventions Facilitate process interventions when warranted: understand task processes across groups and organizations Reframe complexity: diagnosing organizational issues and developing a 'change' strategy Facilitator and coach Develop individual leaders and build effective teams Direct supervision of 4-8 colleagues initially, as needed. Managing a team of 20-30 colleagues plus. Indirectly, managing work executed by strategic outsourcing vendors. Position located in St Louis, MO or Chapel Hill, NC. Frequent travel between Pfizer sites, including Andover/ Cambridge, MA, St Louis, MO, Pearl River/ New York, NY, and Chapel Hill/Sanford, NC, South San Francisco, CA. Travel to support business interactions and process Tech Transfer to contract manufacturing organizations in USA/ EU, as appropriate. QUALIFICATIONS PhD degree in Molecular Biology/ Cell Biology/ Chemical or Biochemical Engineering/ Immunology or related field with 15+ year's experience in biotechnology/ biopharmaceutical industry. This position requires a proactive, pragmatic, flexible person with excellent leadership qualities, strategic thinking, communication & presentation skills, broad expertise in research and process development and strong experience with regulatory and/or safety risk management issues. The Senior Director, Gene Therapy Process Development, will collaborate with internal and external stakeholders in a professional and enthusiastic manner, and must work well on multiple tasks and effectively prioritize to meet personal and team goals in a matrixed team environment. The Senior Director will contribute to ongoing efforts to enhance team effectiveness through involvement in continuous improvement initiatives. Process Management - Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources. Organizational Agility - Knowledgeable about how organizations work; knows how to get things done both through formal channels and the informal network; understands the origin and reasoning behind key policies, practices, and procedures; understands the cultures of organizations. Change Management - Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty. Time management - Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities. Relevant and substantial technical experience in some or all of the following areas: Molecular biology/ cell biology Process development and bioprocess engineering and production for gene therapy products Familiarity with cGMPs and appropriate Regulatory Guidance documents and GLP/GMP regulatory requirements Demonstrated supervision/ leadership of scientists and team including key participation on multi-disciplinary project teams A demonstrated consistent innovator who can successfully drive external development collaboration and internal development programs A well established external scientific reputation, including strong publication record Broad knowledge of relevant Intellectual Property (IP) and experienced in IP strategy development COMPETENCIES Strategic & Innovative Thinking Shows fresh, insightful thinking by developing creative approaches to processes and practices, products and solution services, business models and strategies Acts Decisively Makes timely and effective decisions by applying technical, business and financial acumen. Acts with urgency and removes barriers that hinder productivity Seizes Accountability Results-oriented self-starter who takes personal accountability for outcomes and thrives on increasing levels of responsibility by taking actions to move the business forward, even when decisions are shared or ambiguous Build Effective Teams Creates strong and cohesive teams based on trust and transparency (open communication, clear goals and responsibilities) and development of others Leads change Provides visible, passionate and optimistic organizational / technical / personal leadership; has the technical acumen and stake-holder understanding to identify opportunities for impactful change; builds alignment, establishes a path and drives to implementation Grows Leaders Actively coaches and develops senior talent and teams. Builds leadership bench strength for Pfizer. Provides opportunities and experiences to develop skills, competencies and business knowledge 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. Additional Offer Details: Last Date to Apply for Job: October 15, 2017 This job is (Pfizer) (Exempt) (US/PR) Grade: 018 Additional Location Information: Chapel Hill, NC or St. Louis, MO Eligible for Relocation Package: yes Eligible for Employee Referral Bonus: yes 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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. 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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