J&J Family of Companies
Senior Scientist, Analytical Development, Advanced Therapies
J&J Family of Companies, Malvern, Pennsylvania, United States, 19355
Senior Scientist, Analytical Development, Advanced Therapies
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. We are searching for the best talent for a Senior Scientist, Analytical Development, Advanced Therapies to be located in Malvern, PA. You will be responsible for: Leading method development, validation, tech transfer, and lifecycle support activities for Viral Potency and Characterization methods. Supporting regulatory filings, including INDs and BLAs. Representing the department on cross-functional and external teams and act as a technical expert on cell, biochemistry, and biophysics based virology methods. Communicating complex technical concepts to partners. Accurately capturing data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements. Qualifications / Requirements: Minimum of Ph.D. or equivalent advanced degree in Biochemistry, Virology, Biological Science, or a related field OR a Master's degree with 4 years of experience in biopharmaceutical development OR a Bachelor's degree with 6 years of relevant experience is required. Experience & Skills: Extensive experience in the development of cell and biochemical methods pertaining to viral characterization and infectivity. Examples include cell based viral infectivity assays, plaque assays, physical titer assays, viral particle imaging, and protein interaction analysis using ELISA, SPR, BLI, or KinExA. Experience with method validation and method transfer to a QC environment; including in-depth knowledge of ICHQ14 and ICHQ2(R2) is preferred. Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data. Strong written and verbal communication skills with the ability to convey complex scientific concepts clearly. Strong analytical problem solving, planning and organizational skills are 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 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.
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. We are searching for the best talent for a Senior Scientist, Analytical Development, Advanced Therapies to be located in Malvern, PA. You will be responsible for: Leading method development, validation, tech transfer, and lifecycle support activities for Viral Potency and Characterization methods. Supporting regulatory filings, including INDs and BLAs. Representing the department on cross-functional and external teams and act as a technical expert on cell, biochemistry, and biophysics based virology methods. Communicating complex technical concepts to partners. Accurately capturing data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements. Qualifications / Requirements: Minimum of Ph.D. or equivalent advanced degree in Biochemistry, Virology, Biological Science, or a related field OR a Master's degree with 4 years of experience in biopharmaceutical development OR a Bachelor's degree with 6 years of relevant experience is required. Experience & Skills: Extensive experience in the development of cell and biochemical methods pertaining to viral characterization and infectivity. Examples include cell based viral infectivity assays, plaque assays, physical titer assays, viral particle imaging, and protein interaction analysis using ELISA, SPR, BLI, or KinExA. Experience with method validation and method transfer to a QC environment; including in-depth knowledge of ICHQ14 and ICHQ2(R2) is preferred. Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data. Strong written and verbal communication skills with the ability to convey complex scientific concepts clearly. Strong analytical problem solving, planning and organizational skills are 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 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.