Principal Scientist, API Upstream Process Development

Johnson & Johnson is hiring for a Principal Scientist, API Upstream Process Development in Malvern, PA.

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.

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.

We are upstream process development group and are hiring a Principal Scientist in our team. In this position you will be contributing to cell culture process development within the therapeutic protein process development group in Malvern, PA .

Key Responsibilities:

• Design and execution of experiments
• Analyze data and write/review reports.
• Lead and participate in development of control strategy
• Scaleup the process from lab to pilot/manufacturing scale
• Evaluate facilities fit for the process, and perform tech transfer to manufacturing site
• Plan and manage process validation (laboratory and manufacturing-scale)
• Work in multi disciplinary CMC team with representatives from analytical, manufacturing, quality and other functions.
• Lead and direct the work of junior scientists directly or indirectly reporting to you.
• Lead process modeling for bioreactor scale up, tech transfer, and in support of process troubleshooting
• Lead and participate in scientific investigations and trouble-shoot process issues that arise during development, technology transfer, or scale-up
• Contribute to regulatory filings
• Participate in technology development
• Coordinate laboratory training initiatives,

You will be working in a team environment as well as contributing individually to meet project and department objectives and timelines.

Qualifications

Education:

• Minimum of a Bachelor's Degree in Chemical Engineering, Biological Sciences, Cell Biology, Biochemistry or a related field with at least 8 years of relevant experience OR MS degree with 5 years OR PhD with 3 years is preferred.

Experience and Skills:

Required:

• Hands-on experience with laboratory scale cell culture bioreactor equipment and instrumentation.
• Knowledge of large molecule drug substance (API) upstream manufacturing process development.
• Knowledge of cell culture media characterization and/or optimization.
• Familiarity with or hands-on experience with analytical methods typically used in the manufacture and characterization of recombinant proteins is preferred.
• It is required that the candidate be highly organized and capable of managing/pursuing multiple projects, and have good written and verbal communication skills.
• Experience maintaining written records of work in the form of laboratory notebooks (paper or electronic) is required.
• The ability to report data, present findings to management is required.
• Experience with team-based collaborations and direct/indirect management of staff is required.
• Occasional domestic or international travel will be required.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.