Technical Fellow (Director), Advanced Therapies - MSAT
Technical Fellow (Director), Advanced Therapies - MSAT
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$ 146000 - 251850
1 Vacancy
Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at
Job Function:
Supply Chain EngineeringJob Sub Function:
Process EngineeringJob Category:
People LeaderAll Job Posting Locations:
Raritan New Jersey United States of AmericaJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.
Learn more at are searching for the best talent for a Technical Fellow (Director) Advanced Therapies - MSAT to be in Raritan NJ Titusville NJ Malvern PA or Spring House PA.
Purpose:
The Technical Fellow serves as a subject matter expert (SME) in CAR-T manufacturing and Quality Control analysis playing a pivotal role in ensuring the quality and safety of cellular therapies. This position is critical in addressing challenges that arise when non-conforming products or deviations are generated during the manufacturing process which can impact patient treatment. The Technical Fellow actively engages with healthcare providers to navigate these challenges facilitating clear communication and collaborative problem-solving.
In addition to direct interaction with healthcare providers the Technical Fellow curates and analyzes manufacturing case studies to expedite the release of drug products. This role requires deep expertise in key areas including apheresis collection cryopreservation cell processing quality control testing and quality release processes. The Technical Fellow provides insights to both internal manufacturing teams and external partners ensuring adherence to the highest standards of quality.
The Technical Fellow is also an integral member of various site/network operational teams including planning release clinical/commercial rapid response teams safety management and site this capacity they contribute to the development of robust strategies that maintain the validated state of cell therapy processes while supporting lifecycle management initiatives involving new technologies automation and technology transfer.
Finally this role serves as a key thought leader and scientific expert driving manufacturing trend investigation teams towards root cause identification. Proactively identifying complex scientific correlations linking deep univariate and multivariate data analyses to T-cell biology fundamentals these role partners with development and site technical operations teams to drive towards robust conclusions. Through successful investigation complex trends can be addressed by reducing non-conformance rates aiding patients in need of rapid treatment.
This position is essential for enabling the CARVYKTI networks technical supply chain and compliance-related objectives. Collaborating across a complex network of internal and external stakeholders this role drives improvements in patient care and enhances the overall efficiency of CAR-T therapy delivery.
You will be responsible for:
Provide deep subject matter expertise to batch advocacy efforts for non-conforming products leading manufacturing trend investigations and supporting root cause identification
Engage with key opinion leaders in cell therapy space academics physicians hospital/medical centers lead to drive down patient related contributions to non-conforming product. Engage with new markets to set up for success during the initial launch period (aiding in education on patient factors/contributions to manufacturing success)
Provide deep subject matter expertise on initiatives aimed at reducing non-conforming product rates through projects that may/may not require regulatory approval
Provide technical support to regulatory filings regulatory inspections and health authority questions.
Qualifications:
PhD in Chemical Engineering Microbiology Cell Biology or related with 10-12 years of overall experience is required; 7 years of biotech/pharmaceutical experience or equivalent industry experience is highly preferred.
Hands-on experience in Manufacturing Operation and/or R&D in a biopharmaceutical manufacturing setting (ie. cell/gene therapy products vaccines or any other advanced therapy products)
Experience working with contract partners and internal manufacturing sites
Expert knowledge of T-cell biology
Expert knowledge of cell and gene manufacturing processes
Expert knowledge of GMP/quality considerations for commercial manufacturing
Expert knowledge of evolving ATMP health authority expectations/regulations
This role may require up to 20% of domestic or international travel.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .
The anticipated base pay range for this position is :
$146000 to $251850 AnnualAdditional Description for Pay Transparency:
The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: oVacation up to 120 hours per calendar year oSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year oHoliday pay including Floating Holidays up to 13 days per calendar year oWork Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource. For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .Required Experience:
Director
Employment Type
Full-Time
