Exp Sci Biotherapeutics RD

Position Summary

The role of Experienced Scientist in TDS-API supports upstream product development. The role is responsibleinthe execution oftimelyand effective development of upstream processes for new cell and gene therapies. Leads method development qualification validation and transfer activities and write protocols and reports. The Experienced Scientist will work in an environment that values innovation leadership scientific excellence urgency and personal accountability.

Core Duties & Responsibilities

• Supports upstream product process development

• Work in a team environment as well as contributing individually to meet project timelines and objectives

Roles Responsibilities:

• Supports method development qualificationvalidationand transfer activities and write protocols and reports

• Strong ability to interpret metabolites gassing data to improve cell culture process development

• Lead methods development qualification validation and transfer activities

• Support writing of analytical sections of regulatory submissions and support regulatory filings including INDs and BLAs

• Ability tocomply withregulatory and training requirements

• Work ata high levelof autonomy develops upstream processes of early assets.

• Supports all aspects of laboratory and occasional pilot-scale or manufacturing scale

• Leads the processes involved with the preparation and submission of TechnologyTransfertechnical reports patentapplicationsand manuscripts.

• Leadscontinuous improvementformethodsprocessesand/or scientific procedures.

• Proactively investigate propose and develop improvements to existing processes ordevelopsnew processes.

• Communicates with partneringdepartments inasappropriate fornew assets.

• Analyzes data inhighly complexsituations involving the evaluation of tangible and identifiable variables to arrive at creative and effective solutions including statistical approaches toestablishdesign space for methods.

• Supports inthe scale-up and technology transfer for manufacturing processes.

• Makes a positive contribution to the organizationseeksopportunities for improvement.

Experience Required

• Demonstrated experience in cell culture product process development manufacturing process development process validations and manufacturing investigations across functional groups

• Strong background of virologyimmunologyor bioprocess engineering or related scientific methodologies.

• Experience in the design and execution of assay validation parameters.

• Familiarity with statisticalmethodologysuch as DOEs regulations including EP andUSPand experience with process excellencemethodologydesired butnot.

• Strong problem-solving skills for developing creative innovative solutions and meeting projectobjectivesare required.

• Experience working in acGLPenvironment is preferred.

• Highly organized and capable of managing/pursuing multiple projects independently.

• Ensures project results findings and dataiscommunicated to management in a clear andtimelyfashion.

Johnson & Johnsonisan 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 federalstateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnsoniscommitted to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to requestan accommodation please contact us via contactAskGSto be directed to your accommodation resource.

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