Tech Transfer Lead, Drug Substance Operations

Novavax Gaithersburg , MD 20877

Posted 3 weeks ago

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

We are currently preparing for process validation and licensure of a late phase seasonal influenza vaccine and beginning phase I clinical work for a vaccine against the SARS-nCoV-2 novel Coronavirus. To assist with these programs, we are seeking a Tech Transfer Lead who is responsible for drug substance CMC-related activities across the Novavax product portfolio, including development, tech transfer, manufacturing, and supply of clinical drug substance (DS). The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities. Transfer may be to CMOs outside the US with significant travel required.

Must be flexible and open to significant travel

Responsibilities include, but not limited to:

Responsibility for drug substance technology transfer activities from preclinical development through commercial supply -

  • Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DS in support of ongoing clinical programs

  • Delivery of robust, scalable and cost-effective manufacturing processes that meet or exceed the target clinical profile

  • In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards

  • Oversee execution of the validation of DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations

  • Assisting with the writing and reviewing documents for INDs / regulatory section submissions

  • Prepare, review, or edit cGMP batch records, CMC regulatory, and Quality documents

  • Provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages

  • Provide technical/team support and leadership for technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. media, buffers and cleaning solutions

  • Collaboration with other CMC team members to build and execute the CMC development plan

  • Significant travel may be required, both domestic and international (up to 50%)

Minimum Requirements:

  • MS or BS in engineering, chemistry, biology, or related discipline

  • At least 4+ years of experience in pharmaceutical or biological operations

  • Proven experience in collaborating in matrix teams in a technical environment

  • Strong program management and project management skills and adept at working collaboratively with cross functional teams

  • Strong interpersonal and communication skills

  • Knowledge of protein production and purification manufacturing technologies, such as:

  • Cell culture

  • Shake flasks and stirred tank bioreactors

  • Clarification by depth and tangential flow filtration

  • Column chromatography

  • Experience in oversight of CDMOs for process development, characterization, technology transfer, and release

  • Knowledge of CMC development from pre-clinical through clinical to commercialization

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. We are currently preparing for process validation and licensure of a late phase seasonal influenza vaccine and beginning phase I clinical work for a vaccine against the SARS-nCoV-2 novel Coronavirus. To assist with these programs, we are seeking a Tech Transfer Lead who is responsible for drug substance CMC-related activities across the Novavax product portfolio, including development, tech transfer, manufacturing, and supply of clinical drug substance (DS). The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities. Transfer may be to CMOs outside the US with significant travel required. Position may require living at job site for period of time Responsibilities include, but not limited to: Responsibility for drug substance technology transfer activities from preclinical development through commercial supply - * Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of DS in support of ongoing clinical programs * Delivery of robust, scalable and cost-effective manufacturing processes that meet or exceed the target clinical profile * In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards * Oversee execution of the validation of DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations * Assisting with the writing and reviewing documents for INDs / regulatory section submissions * Prepare, review, or edit cGMP batch records, CMC regulatory, and Quality documents * Provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages * Provide technical/team support and leadership for technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. media, buffers and cleaning solutions * Collaboration with other CMC team members to build and execute the CMC development plan * Significant travel may be required, both domestic and international (up to 50%) Minimum Requirements: * MS or BS in engineering, chemistry, biology, or related discipline * At least 4+ years of experience in pharmaceutical or biological operations * Proven experience in collaborating in matrix teams in a technical environment * Strong program management and project management skills and adept at working collaboratively with cross functional teams * Strong interpersonal and communication skills * Knowledge of protein production and purification manufacturing technologies, such as: * Cell culture * Shake flasks and stirred tank bioreactors * Clarification by depth and tangential flow filtration * Column chromatography * Experience in oversight of CDMOs for process development, characterization, technology transfer, and release * Knowledge of CMC development from pre-clinical through clinical to commercialization Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease. Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan. Equal Opportunity Employer/Veterans/Disabled Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Novavax Gaithersburg MD

Tech Transfer Lead, Drug Substance Operations

Novavax