Johnson and Johnson is currently seeking a Senior Principal Scientist, Bioanalysis located in Spring House, PA or Beerse, Belgium.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
Want more jobs like this?
Get jobs delivered to your inbox every week.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Bioanalytical Discovery and Development Sciences organization develops, validates, and conducts bioanalytical sample analysis across the entire J&J Innovative Medicines R&D development portfolio from discovery through development. We are looking for an accomplished and dedicated scientist to support the J&J portfolio spanning all modalities and therapeutic areas in the execution of bioanalytical activities for assigned programs. This individual will serve as an individual contributor and will be responsible for the development of bioanalytical strategies for all phases of development, oversight of timelines, review of data, review of assay trends, and contributing to the various health authority documents required for market registration.
Primary responsibilities:
• Serve as the Bioanalytical Lead for multiple programs and represent the bioanalytical function to cross-functional team members including Clinical Pharmacology and Pharmacometrics, Clinical Trial Leads, Compound Development Teams and Chemistry, Manufacturing & Controls (CMC) to ensure clear and transparent communication of information necessary for delivering high-quality, compliant bioanalytical data in support of the development portfolio.
• Contribute to regulatory submission documents of investigational drug products supported by the bioanalytical function within J&J Innovative Medicine.
• Support the oversight of externally conducted bioanalysis at Contract Research Organizations (CROs). This individual will work closely with team members in the Bioanalytical Outsourcing and Vendor Management team.
• Be empowered to make decisions, act with vitality, embrace new ideas and take data-driven, calculated risks. The individual will be accountable for their commitments, instill trust in their stakeholders and encourage cross-functional team members to succeed while ensuring care for themselves and others.
Qualifications
Education:
• Bachelor's degree in Chemistry, Biochemistry, Biology, or a related scientific field is required
• Advanced degree (Master's, Ph.D.) in a scientific field is preferred
Required:
• 10+ years of pharmaceutical or contract research organization (CRO) experience with a Bachelor's degree; or 8+ years with a Master's degree; or 6+ years with a Ph.D
• Strong knowledge of large molecule bioanalytical techniques such as electrochemiluminescence (ECLIA), immunocapture LC-MS/MS and/or other ligand binding assay formats across different protein modalities
• Demonstrated expertise in immunogenicity assay development, validation and in-study bioanalysis
• Able to independently review immunogenicity data and communicate the impact of the results to the broader clinical team
• Expertise in relevant bioanalytical regulatory guidelines
• Project management experience
• Must have excellent oral and written communication skills, strong negotiation skills, and the ability to collaborate with all levels and influence decision-making across an organization
Preferred:
• Expertise in supporting health authority filings across various modalities as demonstrated with contemporary filing experience such BLAs, NDAs, sBLAs as well as other regional health agency contributions.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.