Associate Scientist, Large Molecule

Johnson & Johnson • Malvern, PA

18h • Onsite

About The Position

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. 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.

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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level