Associate Director

3 weeks ago


Raleigh, United States CareerBuilder Full time

Our client is founded by pioneers in ocular gene therapy and is a clinical-stage gene therapy company focused on leveraging genetic medicine to reverse or prevent blindness. The company has an ongoing Phase I/II clinical trial evaluating a potential therapy for one of the most common causes of blindness in children. Its pipeline of clinical and preclinical assets is powered by adeno-associated virus (AAV) technology.

The successful candidate will lead and manage a team of process and analytical development scientists responsible for the development, optimization and characterization of AAV manufacturing platform to supply our next generation AAV vectors supporting early and late-stage development programs. Reporting to the Vice President, CMC, the candidate will be responsible for functional leadership of the process development team. The team will collaborate to ensure the development, transfer, and characterization of robust processes used for both clinical and commercial production.

Job Responsibilities
Lead the Process Development group to develop globally compliant, robust, well-characterized, scalable and high quality AAV production platform to support both internal and external (CDMO) manufacturing requirements for preclinical, clinical and ultimately commercial programs.
Recruit, manage, train and retain a motivated and capable process development team; establishing and managing performance to individual and corporate goals.
Collaborate and work cross-functionally with internal and external Development, Manufacturing, Regulatory Affairs, and Quality functions to ensure all activities are scheduled and executed on time in accordance with program timelines.
Identify, evaluate and implement novel technologies and systems in the development of the Companys manufacturing and analytical platforms.
Participate in the transfer of technology to contract development and testing organizations to ensure the successful and precise execution of activities. Includes routine support of CDMOs to maintain reliable supply.
Work with departmental leadership to develop and implement standard work practices to ensure a safe and compliant working environment.
Ensure the generation and documentation of all scientific data and technical reports are managed in compliance with best data integrity practices.
Prepare and review of regulatory and CMC documents, including authoring of module 3 sections of regulatory submissions.

Job Requirements
BS/MS with 15+ years of relevant experience or PhD in Chemical Engineering or Biological/Biochemical sciences with 10+ years of relevant experience in AAV gene therapy.
Demonstrated experience with track record of success leading upstream and downstream technical teams, experience in process scale up and development of scale down models. Advanced knowledge of DOE principles and process characterization experience.
In-depth technical understanding of process development and process and analytical validation in viral vector manufacturing.
Demonstrated cross-functional leadership and ability to work with teams to drive results. Proficiency in strategic planning, cross-functional performance management, people management, and technical leadership.
Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a dynamic and fast-paced environment.
Strong team building, organizational, collaboration and communication skills.
Excellent written and verbal communication skills; strategic thinker with strong problem-solving skills and effective interpersonal communications.
Established experience with tech transfer to multiple CDMOs is a plus.

#J-18808-Ljbffr


  • Associate Director

    3 weeks ago


    Raleigh, United States North Carolina State University Full time

    The Associate Director will serve as a leader within the Institute, working in conjunction with and supporting the Institute Director in furthering the Institutes mission and goals. The Associate Director will be responsible for the oversight of hig Director, Associate, Climate Change, Research, Commercial Driver, Management, Education, Science


  • RALEIGH, United States North Carolina State University Full time

    Reporting to the Executive Director of Philanthropy, the Associate Director of Philanthropy will help manage fundraising activities and support the achievement of the Poole College of Management annual fundraising goals. This position works both inde Director, Associate, Commercial Driver, Business Services


  • RALEIGH, United States North Carolina State University Full time

    Reporting to the Executive Director of Corporate Foundation Relations, the Associate Director will work in close collaboration with members of the University Advancement team and serve as the primary prospect manager for a portfolio of foundations, c Director, Corporate, Associate, Relations, Relationship, Commercial Driver, Business Services


  • Raleigh, United States WakeMed Full time

    About WakeMed: Serving the community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and well-being of our community, we are committed to providing outstanding and compassionate care. For more information, visit www.wakemed.org. EOE Position Information: Associate...


  • Raleigh, United States North Carolina State University Full time

    North Carolina State University was founded in 1887 with the purpose of creating economic, societal and intellectual prosperity for the people of North Carolina. Today NC State is the largest university in North Carolina, with more than 37,000 high-performing students, 9,000 preeminent faculty and staff and 260,000 alumni. NC State is a research-extensive...


  • Raleigh, United States Grant Thornton International Full time

    Grant Thornton is seeking a HRBP Associate Director to join the team in Charlotte, NC. The Human Resources Business Partner-Associate Director (HRBP AD) serves as an integral business partner on the People Experience team. The HRBP AD partners closely with firm leaders to deliver people related programs and initiatives and provide strategic direction and...


  • Raleigh, United States TKC Holdings, Inc. Full time

    This is a 100% Traveling Food Service Director position, the travel will cover most of the state of North Carolina and south eastern Virginia. The Food Service Director plans, directs and coordinates the activities associated with running a single si Food Service, Director, Travel, Service, Food, Restaurant, Manufacturing


  • Raleigh, United States DSJ Global Full time

    Title: Associate Director of Operations - Diaper Manufacturing DSJ Global is seeking an experienced Associate Director of Operations for a permanent position in North Carolina. Our client, a leading diaper manufacturer, requires someone with 3-5 years' experience in paper manufacturing, safety management expertise, and a degree related to operations/supply...


  • Raleigh, United States North Carolina State University Full time

    The Division of Academic & Student Affairs (DASA) is where students discover connections and community. It is where students live, where they gather, where they improve themselves, each other, and their university. DASA is where students seek guidance and support, both in and outside of the classroom. The division serves all students at NC State through...

  • Program Associate

    6 days ago


    RALEIGH, United States North Carolina State University Full time

    The University Program Associate (UPA) for Pack Essentials provides administrative and programmatic support for the implementation of institutional initiatives that support students in meeting their basic needs. The UPA:Program Administration and Sup Associate, Program Director, Program, Support, Commercial Driver, Financial, Business Services


  • Raleigh, United States Calyx Living Full time

    Calyx Senior Living Community Marketing Director Calyx Senior Living is actively seeking an enthusiastic, sales-driven, competitive and success-motivated Community Marketing Director for our BRAND NEW assisted living community located in beautiful Fuquay-Varina, one of the fastest growing towns in North Carolina, and minutes from its two vibrant and historic...

  • Director of ICU|PCU

    3 days ago


    Raleigh, United States MLee Healthcare Full time

    Job DescriptionJob DescriptionDirector of ICU/PCUMLee Healthcare has been engaged by our top-rated client North of Raleigh to recruit a Director of ICU/PCU for their growing team. If you want to work for an amazing facility with fulfilling culture and work-life balance, then apply and come join the best team in healthcare!Job Summary:We are seeking a Nursing...


  • Raleigh, United States Carillon Assisted Living Full time

    Carillon Assisted Living Sales and Marketing Director Carillon Assisted Living is actively seeking an enthusiastic, sales-driven, competitive and success-motivated Sales and Marketing Director for our BRAND NEW assisted living community located in beautiful Fuquay-Varina, one of the fastest growing towns in North Carolina, and minutes from its two vibrant...


  • Raleigh, United States Learning Care Group Full time

    This is more than just a daycare job. It’s a journey, where you learn, grow, thrive—and play—every day. Leading a child care center is something special. We’re hiring and we want difference makers who will inspire children to become lifelong learners.In a Center Director, we look for committed individuals who want to have a positive impact in the...


  • Raleigh, United States North Carolina State University Full time

    The Senior Research Associate will work to with and lead teams of researchers to produce internal and external reports specifically for community college stakeholders including college presidents, policymakers and practitioners.This role will primarily support quantitative research in one or multiple of the following areas: completion/transfer; labor market...


  • Raleigh, United States MinistryHub Full time

    Job DescriptionJob DescriptionMinistryHub is honored to partner with Holland's Church in their search for a Director of Youth Ministries. Please direct all applications through MinistryHub and any inquiries to hello@ministryhub.org.Overview:The Director of Youth Ministries will provide leadership to nurture an authentic faith in God in our youth, 6th to...


  • Raleigh, North Carolina, United States Grace Federal Solutions LLC Full time

    We are Grace,Grace Federal Solutions' greatest success is the employees of Grace. At Grace, we recognize the significant role each Grace employee plays in helping to grow and transform the company. Grace follows 5 principles: client service, purpose, mutual respect, collaboration, and accountability. To build the best healthcare services company that...


  • Raleigh, United States TRANZACT Full time

    Job DescriptionRole Overview: We're seeking a results-driven Associate Director of Paid Social Media Marketing to lead our performance marketing company's Paid Social Media Advertising programs. If you have a proven track record driving impactful results and ROI through Paid Social Media Marketing (Meta, Instagram) and are looking for your next career move...


  • Raleigh, United States WTW inc. Full time

    Role Overview: We're seeking a results-driven Associate Director of Paid Social Media Marketing to lead our performance marketing company's Paid Social Media Advertising programs. If you have a proven track record driving impactful results and ROI through Paid Social Media Marketing (Meta, Instagram) and are looking for your next career move leading teams...

  • Marketing Director

    3 weeks ago


    Raleigh, United States Alpha Home Caare Services Inc. Full time

    Job DescriptionJob DescriptionOversee marketing for the Assisted Living communities with the company. Create a marketing plan for each facility to increase the census ongoing. Monitor and problem solve residents ledgers to ensure finances are received according to contract.Responsibilities:Maintain census with each facility with a plan for increase in...