Senior Scientist, Analytical Research and Development Full-time

Senior Scientist (R3) – Biologics AR&D GMP Operations

North American GMP Operations, Rahway, NJ

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 Senior Scientist (R3) to join our Rahway, NJ team in Biologics AR&D GMP Operations. The role involves developing and performing analytical methods for raw materials testing, authoring and maintaining Standard Operating Procedures (SOPs), supporting instrument qualification, and collaborating with production for timely, compliant raw material release for clinical batch production. Candidates should thrive in a fast-paced, multidisciplinary setting and will play a key part in advancing Biologics commercialization.

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:

• Execute activities in accordance with Good Manufacturing Practices (GMP).
• Author, review, and maintain Standard Operating Procedures for raw materials testing, instrument operation, and laboratory processes.
• Support instrument qualification (IQ/OQ/PQ) activities for analytical equipment.
• Implement traditional and advanced analytical methods to support execution of raw material testing.
• Serve as an SME for raw materials analytical testing, procedures, and practices at our Biologics Development Center in Rahway and North Wales, PA labs.
• Oversee project timelines and deliverables, focusing on coordinating raw materials testing to meet clinical program milestones. In this role, work closely with the production team, process development, and analytical development staff to understand manufacturing schedules and ensure prompt analytical support is provided.
• Support the development and improvement of raw material workflows for existing and newly constructed manufacturing facilities in our network.
• Support biologics registrations, product launches, and troubleshooting activities.
• Support compliance audits, inspection activities, and investigation/CAPAs.
• Advance strategic initiatives across matrixed teams.

• Author and review technical documentation including regulatory submissions.
• Additional responsibilities as assigned to support the evolving needs of the department.

Qualifications:

• Ph.D. in biology, chemistry, biochemistry or related field or M.S. with a minimum of 3 years of relevant experience or B.S. with a minimum of 7 years of relevant experience.

Experience and Skills:

Required:

• Knowledge of chemical properties and traits of common biologics manufacturing materials, including salts, excipients, media components, and chromatography resins.
• Proficient in analytical techniques including spectroscopy (such as FTIR and RAMAN), UV spectrophotometry, and compendial methods like pH and conductivity testing.
• Strong organizational skills with proven ability to manage timelines and deliverables.
• Able to proactively recognize and communicate potential risks.
• Proven ability to solve technical problems with innovation.
• Ability to work independently and within a matrixed team.
• Effective communication (oral and written) and leadership skills.
• Strong interpersonal skills with adeptness to lead by influencing others.
• Self-motivated with a positive attitude and proven performance record.
• Willingness to occasionally work irregular hours, including evenings and weekends, as needed.
• Occasional travel to our Pennsylvania laboratory as required.

Preferred:

• GMP experience and understanding of data integrity principles (ALCOA+) for documentation are highly preferred.
• Experience and understanding of testing raw materials in pharmaceutical or similar settings.
• Skilled in LIMS, Empower, electronic notebooks, and data analytics platforms.
• Knowledge of cGxP operation, USP, EP, ICH, and FDA guidelines.
• Experience with analytical method validation and life cycle management.
• Deviation management and change control processes.
• Experience with method development and/or regulatory submissions.
• Continuous improvement or lean six sigma methodology

Required Skills: Accountability, Adaptability, Analytical Method Development, Analytical Validation, Assay, Assay Development, Bioanalytical Analysis, Communication, GMP Compliance, GMP Environments, Innovative Thinking, IR Spectroscopy, Laboratory Analysis, Laboratory Techniques, Manufacturing, Raman Spectroscopy, Raw Material Testing, Self Motivation, Strategic Thinking, Technical Issues, Technical Writing, Ultraviolet-Visible UV/VIS Spectrophotometers, Working Independently

Preferred Skills:

Accountability, Adaptability, Analytical Method Development, Analytical Validation, Assay, Assay Development, Bioanalytical Analysis, Communication, GMP Compliance, GMP Environments, Innovative Thinking, IR Spectroscopy, Laboratory Analysis, Laboratory Techniques, Manufacturing, Raman Spectroscopy, Raw Material Testing, Self Motivation, Strategic Thinking, Technical Issues, Technical Writing, Ultraviolet-Visible UV/VIS Spectrophotometers, Working Independently