Exp Sci Biotherapeutics RD

Position Summary 

The role of Experienced Scientist in TDS-API supports upstream product development. The role is responsible in the execution of timely and 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 

Role’s Responsibilities: 

• Supports method development, qualification, validation and 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 to comply with regulatory and training requirements 

• Work at a high level of 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 Technology Transfer technical reports, patent applications and manuscripts. 

• Leads continuous improvement for methods, processes and/or scientific procedures. 

• Proactively investigate, propose, and develop improvements to existing processes or develops new processes. 

• Communicates with partnering departments in as appropriate for new assets. 

• Analyzes data in highly complex situations involving the evaluation of tangible and identifiable variables to arrive at creative and effective solutions including statistical approaches to establish design space for methods. 

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

• Makes a positive contribution to the organization, seeks opportunities 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 virology, immunology or bioprocess engineering or related scientific methodologies required. 

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

• Familiarity with statistical methodology such as DOEs, regulations including EP and USP and experience with process excellence methodology desired, but not required. 

• Strong problem-solving skills for developing creative, innovative solutions, and meeting project objectives are required. 

• Experience working in a cGLP environment is preferred. 

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

• Ensures project results, findings and data is communicated to management in a clear and timely fashion. 

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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. 

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