Associate Scientist, Downstream Processing

We are searching for the best talent for our Associate Scientist, Downstream Processing position, to be located in Malvern, PA., Purpose: The Associate Scientist, Downstream Processing supports biologics purification process development within the Protein Therapeutics API Development (Downstream Purification) organization. This role will support purification process development for protein therapeutics. The Associate Scientist will assist in design, execution, and documentation of bench-scale laboratory experiments for protein purification operations including chromatography (affinity, ion-exchange, hydrophobic interaction) and filtration (UFDF, TFF, depth filtration). This person will contribute individually and as part of a team to meet project timelines and objectives with an emphasis on early-phase process development for preclinical therapeutics. The Associate Scientist will also maintain compliance with data documentation, safety, and other company policies and procedures.

You will be responsible for:

• Defining work packages and streamlining purification development strategies for new molecular entity (NME) candidates to support early phase clinical manufacturing of biotherapeutics (monoclonal antibodies, bi/multi-specific antibodies, bioconjugates, and other)
• Executing chromatography and filtration experiments with a focus on product quality attributes, product recovery, and manufacturing facility fit constraints
• Assisting in process characterization, process scale-up, and technology transfer of downstream unit operations
• Working cross functionally with upstream (cell culture), analytical development, formulation sciences, and manufacturing organizations to meet overall program deliverables and timelines
• Authoring and reviewing technical or regulatory documents
• Keeping accurate records, following instructions, and complying with company and EHSS policies.
• Capturing data accurately and in a timely manner, maintain detailed records in compliance with applicable cGLP, safety, and environmental requirements.

• B.S degree in Chemical Engineering, Biochemistry, Biotechnology, or related discipline with 0 - 5 years of relevant experience OR M.S degree in Chemical Engineering, Biochemistry, Biotechnology, or related discipline with 0 - 3 years of relevant experience.
• Familiarity with protein purification, bioprocessing, or related scientific methodology
• Basic understanding of experimental design, performance, and analysis
• Self-motivated and eager to learn
• Strong written and verbal communication skills
• Highly organized and capable of working in both a team environment and individually with limited supervision
• Proficiency in MS Office (Excel, Word, PowerPoint)

Preferred:

• Solid understanding of statistical experimental design and analysis (DoE methodology)
• Hands-on experience working with Akta fast protein liquid chromatography (FPLC) systems
• Hands-on experience in protein bioprocessing techniques such as chromatography, filtration (depth, tangential flow, UFDF), and/or analytical methods (SDS-PAGE, UV/Vis, etc.)
• Experience working with statistical design software such as JMP, minitab, or related programs, Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Clinical Trial Protocols, Collaboration, Data Quality, Drug Discovery Development, Execution Focus, Molecular Diagnostics, Pharmacogenetics, Problem Solving, Research Documents, Scientific Research, Technologically Savvy, Troubleshooting, Written Expression

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 jnj.com (https://www.jnj.com.) .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.