Associate Scientist, Large Molecule Full-time NEW

Associate Scientist, Large Molecule (LM)

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.

We are searching for the best talent for an Associate Scientist, Large Molecule (LM). This role will be within our Drug Product Development & Delivery (DPD&D) Global Process Development (GPD) team and will sit in our Malvern, PA location.

Purpose: The candidate for this position will be responsible for process development of fill/finish manufacturing processes of biotherapeutic products. The candidate will support the design and execution of development activities in support of process and fill-finish activities for large molecules (e.g. monoclonal antibodies, bi-specifics, tri-specifics, etc) to ensure the implementation of manufacturing processes that meet all regulatory requirements and expectations.

You will be responsible for:

• Support biologics drug product development activities from discovery through commercialization, collaborating with global teams representing functions within the Chemistry and Manufacturing Controls (CMC) at Johnson & Johnson's Innovative Medicine.
• Uses underlying physical, chemical, and biological principles to identify the mechanisms and kinetics governing process and product performance and scale up and achieve target process performance at all scales.
• Develops fundamental understanding of large molecule parenteral process unit operations on physical/chemical/biological product quality attributes, specifically freeze/thaw, mixing, filtration, filling process steps and Process Analytical Technology (PAT) based experiments.
• Develops and uses lab based “scale-down” models to evaluate process parameters and ranges and builds knowledge of “scale up” of unit operations to confirm or modify understanding of critical and key parameters.
• Evaluates the suitability of manufacturing processes to existing product, process, and materials platforms and vice versa.
• Works with other development teams and commercial and clinical supply chain to conduct in depth reviews of process performance data to establish/refine and drive process improvements.
• Opportunity to develop process engineering skills including the use of multi-physics software for process modeling and the statistical analysis of data.

Qualifications / Requirements:

• Bachelors degree in Engineering (Biomedical, Bioengineering, Chemical, Electrical or Mechanical) with ~0-3 years experience (including co-op, internships or research experience), OR Masters degree with ~0-1 year of work experience is required.
• A basic understanding of manufacturing principles and processes, preferably with an application to large molecule production.
• Basic understanding and ability to perform data evaluation and statistical analysis.
• Ability to contribute toward and write technical documents as well as the ability to clearly communicate findings and progress to management.
• Ability to collaborate in matrix teams in order to deliver high quality results.
• Motivated, self-starter able to work independently with proven problem solving skills.
• Up to 15% international and domestic travel.

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills: 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