Scientist, Biologics Analytical Research & Development Full-time NEW

Scientist Position

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 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 seeking an enthusiastic Scientist to join our Biologics AR&D GMP Operations team in Rahway, NJ. This position involves supporting separation assays and compendial methods, maintaining GMP readiness, and ensuring consistent business operations. Main responsibilities include method optimization, validation, analytical transfers, life cycle management, and conducting release and stability tests. The ideal candidate will excel in a dynamic, multidisciplinary environment and contribute significantly to the commercialization of Biologics. The analyst will maintain laboratory GMP compliance by training staff, improving processes, preparing for audits, and overseeing sample inventory and shipments.

The incumbent will work with stakeholders such as Technical Operations, Manufacturing, Analytical Development, Large Molecule Assay Validation, Quality Assurance, and CMC Regulatory Affairs to solve technical issues, offer scientific guidance throughout development, and manage deliverables to advance the pipeline.

Responsibilities

• Validate and implement analytical methods to support release and stability testing of clinical materials.
• Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP).
• Support biologics registrations, product launches, and troubleshooting activities.
• Author and review technical documents.
• Act as compliance/Quality SME to support preparation for audits and inspections.
• Provide oversight for lab activities to maintain GMP requirements and inspection ready status.
• Provide SME guidance for investigation/CAPAs and change control.
• Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes.
• Manage laboratory equipment, laboratory supplies, and critical reagent inventories.
• Complete assigned work within established project timelines.
• Additional responsibilities as assigned to support the evolving needs of the department.

Qualifications

• 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, or M.S. degree with 1+ year of relevant experience.

Experience and Skills

Required

• At least 1 year experience working in a GMP environment.
• Experience with separation techniques such as HPLC, UPLC, CE, iCIEF, or other advanced technology.
• Proficiency with data analysis.
• Understanding and adherence to ALCOA principles for documentation.
• Strong organizational skills and ability to manage work to meet project timelines.
• Capability to work independently with minimal supervision.
• Ability to identify and resolve common technical issues.
• Effectively engage, communicate, and collaborate with others.
• Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning.
• A willingness to occasionally work irregular hours, including evenings and weekends, as needed.
• Willingness to travel to PA site 25% of the time.

Preferred

• Demonstrated understanding of deviation management and change control processes, paired with proficient authoring capabilities.
• Familiarity with regulatory guidelines and GMP laboratory controls, including audit and inspection support.
• Strong organizational skills, with knowledge of sample inventory management systems and related procedures.
• Technical proficiency in compendial testing methods such as analysis of visible and sub-visible particles, pH, osmolality, color, and clarity.
• Established familiarity with USP, EP, ICH, and FDA regulations.
• Proficient in utilizing LIMS, Empower, electronic notebooks, and other data analytics platforms.

Required Skills: Capillary Electrophoresis (CE), Capillary Isoelectric Focusing (cIEF), GMP Compliance, Good Manufacturing Practices (GMP), High-Performance Liquid Chromatography (HPLC), Laboratory Information Management System (LIMS), Laboratory Techniques, Separation Techniques, Ultra Performance Liquid Chromatography (UPLC)

Preferred Skills: