Bioassay Scientist, Analytical Research & Development Full-time

Scientist (R2) Bioassay

We invite individuals who possess a deep passion for promoting lifesaving and life-enhancing products to join our dynamic team. Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our Company's extensive range of products from candidate selection to market authorization. At our company, we proudly continue to build upon a legacy of groundbreaking innovation while steadfastly upholding the highest standards of ethics and integrity. With a diverse workforce representing a multitude of languages and cultures, we stand unified in our collective mission to deliver revolutionary medicines and products with integrity and transparency.

We are actively seeking an enthusiastic individual to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) Good Manufacturing Practices (GMP) Operations, to support bioassay analysis, including ELISA and cell-based methods. In this role, the selected candidate will be responsible for method optimization, phase-appropriate validation, early and late-stage transfers, SoftMax Pro template validation, cell line maintenance, analytical life cycle management, and release and stability testing. The successful candidate must be able to work in a fast-paced, multidisciplinary environment and will play a pivotal role supporting Biologics to advance commercialization efforts.

The incumbent will collaborate closely with various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline.

Responsibilities

• Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools.
• Validate and implement analytical methods to support release and stability testing of clinical trial materials.
• Support critical reagent qualifications and SoftMax pro template validation activities.
• Document activities in a detailed and organized manner and follow SOPs.
• Author and review technical documents.
• Complete assigned work within established project timelines.
• Support GMP compliance and continuous improvement of laboratory operations.
• Manage laboratory supplies and critical reagent inventories.
• Additional responsibilities as assigned to support the evolving needs of the department.

Experience and Skills

Required

• Minimum of a B.A./B.S. degree in biology, biochemistry, or related scientific field with 3 years of relevant experience in analytical development, validation, and/or quality control, master's degree preferred.
• Experience with mammalian cell culture and ELISAs.
• Document activities in a detailed and organized manner following SOPs.
• Ability to manage work to meet project timelines.
• Capability to work independently with minimal supervision.
• Ability to identify and resolve common technical issues.
• Effectively communicate, collaborate, and engage with others.
• Agile learner who is self-motivated with a positive attitude.
• A willingness to occasionally work irregular hours, including evenings and weekends, as needed.

Preferred

• GMP experience is preferred.
• Experience with LIMS, SoftMax Pro, electronic notebook, or other data analytics platforms.
• Knowledge of assay validation requirements is highly preferred.
• Understanding of cGxP operation, USP, EP, ICH, and FDA guidelines.
• Experience with SoftMax Pro template creation is preferred.
• Familiarity with deviation management and change control processes.
• Experience with method development, qPCR, capillary electrophoresis, chromatographic separations and/or compendial methods is desirable.

Required Skills:

Biochemistry, Cell-Based Assays, Cell Cultures, Collaborative Communications, Fast-Paced Environments, Good Manufacturing Practices (GMP), Immunoassays, Immunochemistry, Interpersonal Relationships, Laboratory Techniques, Maintenance of Cell Lines, Mammalian Cell Culture, Real Time Polymerase Chain Reaction (qPCR), Self Motivation, Standard Operating Procedure (SOP) Writing

Preferred Skills: