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You will be updated with latest job alerts via emailAt 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:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Rockville Maryland United States of America Spring House Pennsylvania 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 an Experienced Scientist API Cell Therapy that will be based in Rockville MD.
Purpose:
The Scientist will reside within the API Cell Therapy group working independently and in conjunction with the cross-functional (Development and External) teams to support program needs. This role is responsible for supporting clinical manufacturing of an autologous CAR-T product including providing guidance to resolve technical issues on the floor and on-call support for Quality to aid in the release of life-saving therapies.
Responsibilities:
Support clinical ramp-up and manufacturing activities of autologous T-cell derived cell therapy processes to internal and CDMO clinical manufacturing
Leverage own experience in cell therapy process development to guide resolution for investigations deviation assessments. and on-floor support for clinical batches
Mentor and train team members in manufacturing support and troubleshooting/investigations; including support for person in plant activities as required
Drive successful clinical campaigns write protocols memos reports reviewing/revising batch records to support successful manufacturing with internal and external partners
Directly support implementation and execution of automated end-to-end manufacturing processes working directly with CMO and internal resources to ensure successful outcomes.
Expertise in existing and emerging systems in this space together with troubleshooting is required
Collaborate with and participate in cross-functional teams to facilitate BLA enabling workstreams
Identify critically assess and evaluate opportunities to improve manufacturing outcomes such as improving success rate throughput reducing cost process time and product quality of the final drug product
Education:
BS or MS in Biological Sciences in Biological Sciences Biomedical Engineering or Immunology and with at least 2-4 years of industry experience (Advanced Degree preferred).
Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required
Knowledge and experience in autologous CAR-T cell therapy manufacturing and technology transfer is required
Prior hands-on experience with automation equipment and end-to-end systems is required; expertise in their operations in both process development and manufacturing environments for cell therapies is highly advantageous
S/he must be detail-oriented highly organized and able to manage multiple tasks handle tight timelines and deliver quality data. Must have excellent communication interpersonal and collaborative skills
Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. Highly adaptable and responsive and committed to completing tasks in a timely fashion
Occasional weekend work may be required; travel to support people in plant activities will be required
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 vertebras and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & 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.
The anticipated base pay range for this position is :
$89000.00 - $161000.00 USDAdditional Description for Pay Transparency:
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: Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year Holiday pay including Floating Holidays up to 13 days per calendar year Work Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits please go to: - The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.Required Experience:
Senior IC
Full-Time