Johnson and Johnson is recruiting for a Principal Scientist, Large Molecule Drug Product Process Development in the Biotherapeutic's Drug Product Development and Delivery organization (Global Process team) located 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/.

The candidate for this position will be responsible for process development and technology transfer of fill/finish manufacturing processes of biotherapeutic products. They will also work and partner with colleagues in MSAT, Quality, Regulatory, and other functions to ensure the implementation of manufacturing processes that meet all regulatory requirements and expectations.

Primary responsibilities:

• Lead late-stage process development, technology transfer, process validation, and filing activities both to and between manufacturing sites.

• Provides scientific and strategic leadership to new product introductions for fill finish processes to external or internal Janssen manufacturers.

• Partnering with MSAT, Manufacturing Site leads, Quality, Regulatory, and other functions for flawless introduction of manufacturing processes into production sites.

• Transfer of the process to the supply chain network in accordance with pertinent regulatory guidelines.

• Lead best product and process at launch, right first time and other technology transfer harmonization/optimization initiatives.

• Must have knowledge of drug substance and/or drug product process.

• Work closely with the formulations and primary container and device teams to ensure end to end process alignment.

• Ability to work independently and have strong communication skills.

Qualifications

Education:

• BS, MS, or PhD in a technical field (Chemical Engineering, Mechanical Engineering or similar) OR equivalent relevant work experience is required.

Required:

• 10 years of experience (including relevant academic research experience) in the biopharmaceutical development and manufacturing area.

• Able to perform and direct data evaluation, statistical analysis, budget management over multiple complex programs.

• Ability to contribute toward and/or direct others to author and approve technical documents as well as the ability to clearly communicate findings and progress to management.

• Ability to influence and collaborate in matrix teams to deliver high quality results with considerations of the bigger picture.

• Motivated, self-starter able to work independently and with demonstrated problem-solving skills.

• Travel: 10-20% - project dependent

Preferred:

• A technical expert on current and future manufacturing principles and processes, with an application to large molecule fill and finish.

• Demonstrated track record of leading highly cross-functional, matrixed teams.

• A recognized expert of engineering scaling principles with the ability to apply knowledge to technology transfer.

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.