Scientist, Analytical R&D
About The Position
Join a dynamic team dedicated to advancing lifesaving and life enhancing medicines. Our team is deeply committed to providing exceptional scientific oversight, supporting our Company’s portfolio from candidate selection through market authorization. At our company, we proudly continue to build upon a legacy of groundbreaking innovation with ethics and integrity. Powered by diverse perspectives, we work as one to deliver transformative medicines with integrity and transparency. We are seeking an enthusiastic Scientist (R2) to join our Rahway, NJ team in Biologics Analytical R&D GMP Operations. This role executes analytical testing for raw materials and supports instrument qualification to enable timely, compliant release of raw materials used in clinical production. The successful candidate will thrive in a fast-paced, multidisciplinary environment and play a key role in advancing biologics commercialization. The incumbent will partner with stakeholders such as Technical Operations, Manufacturing, Analytical Development, Large Molecule Assay Validation, Quality Assurance, and CMC Regulatory Affairs to resolve technical issues, provide scientific guidance across the product lifecycle, and deliver on program commitments.
Requirements
- B.A./B.S. in Biology, Biochemistry, or a related scientific field with a minimum of 3 years of relevant experience (analytical development, validation, and/or quality control), or an M.S. degree with relevant experience.
- At least 1 year of experience working in a GMP environment.
- Experience with analytical methods such as spectroscopy (including FTIR and Raman), UV spectrophotometry, and compendial procedures (such as pH and conductivity measurements).
- Proficiency with data analytics.
- Demonstrated understanding of 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 across teams.
- 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.
Nice To Haves
- Solid background in GMP and a thorough grasp of data integrity principles (ALCOA+) for documentation are highly preferred.
- Familiarity with testing raw materials in pharmaceutical or related environments.
- Skilled in using LIMS, Empower, electronic notebooks, and various data analytics platforms.
- Well-versed in USP, EP, ICH, and FDA guidelines.
- Experienced in handling deviation management and change control processes.
- Proficient in method development and regulatory submission processes.
Responsibilities
- Ensure adherence to GMP requirements and drive continuous improvement of laboratory processes.
- Execute advanced and routine analytical methods to support raw material testing and release.
- Complete assigned work within established project timelines.
- Serve as an SME for raw materials testing, practices and procedures at our Biologics Development Center in Rahway, NJ and North Wales, PA labs.
- Manage laboratory equipment, supplies, and critical reagent inventories.
- Support instrument qualification (IQ/OQ/PQ) activities for analytical equipment.
- Author and review technical documentation, including content that supports regulatory submissions.
- Support biologics registrations, product launches, and troubleshooting activities.
- Support compliance audits, inspection activities, investigations, and corrective/preventative actions.
- Additional responsibilities as assigned to support the evolving needs of the department.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
