Analytical Scientist/ Sr Scientist

EPM Scientific; New York (NY); Vor Ort; USD 80.000 - 120.000; Vollzeit

Zusammenfassung

Join a pioneering biotech company dedicated to transforming patient lives through innovative advancements in biologics. This role as an Analytical Development Scientist is crucial for developing and validating cutting-edge analytical methods for complex biologics. You will support clinical programs and contribute to the continuous improvement of technical operations. If you are passionate about scientific discovery and eager to make a significant impact in biotechnology, this opportunity is perfect for you. Collaborate with a dynamic team and advance your career in a supportive and innovative environment.

Qualifikationen

• 5+ years of experience in biotechnology or pharmaceutical industry.
• Expertise in developing analytical methods for biologics.

Aufgaben

• Develop and validate analytical methodologies for biologics.
• Collaborate with cross-functional teams for comprehensive testing support.

Kenntnisse

Analytical assay techniques

Data interpretation

Communication skills

Project management

Experimental design

Statistical knowledge

Ausbildung

Advanced degree in biological sciences

Tools

Liquid Chromatography

ELISA

R

Python

Jobbeschreibung

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CMC Executive Headhunter - CMC R&D - Analytical Development

Position: Analytical Development Scientist III/ Sr. Scientist

Location: Newark, CA

Company Overview:
This biotech company is at the forefront of innovative biotechnology. They are dedicated to transforming the lives of patients through groundbreaking advancements in biologics. Join their dynamic team and be part of a company that values scientific excellence, collaboration, and continuous improvement. They offer a collaborative and innovative work environment where your contributions will make a significant impact. If you are passionate about scientific discovery and eager to advance your career in biotechnology, we invite you to apply and join the team of dedicated professionals.

Position Summary:
They are seeking a talented Scientist to join their expanding Analytical Development team. This role is integral to their mission of developing and validating cutting-edge analytical methods for the characterization of complex biologics. The Scientist will play a key role in supporting clinical programs, commercial registration, and post-approval enhancements for Revance projects.

Responsibilities:

• Develop, validate, and execute sophisticated analytical methodologies to support the characterization of biologics.
• Author and review technical documents, including analytical methods, protocols, reports, and instrument qualifications.
• Operate and maintain advanced analytical instrumentation and computer control systems.
• Collaborate cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical teams to provide comprehensive analytical testing support.
• Contribute to the continuous improvement of technical operations and project outcomes within the Analytical Development area.
• Support laboratory operations, including inventory tracking, reagent preparation, sample management, and documentation review.
• Ensure compliance with ICH guidelines and global regulations in the execution of analytical and biological methods.
• Adhere to GMPs, GLPs, GCPs, and GDPs as required.

Requirements:

• Extensive experience with analytical assay techniques such as absorbance assays, chromatography, CE-SDS, ELISA, and western blot.
• Proficiency in interpreting data from characterization techniques like AUC, LC/MS, MFI, DLS, and CD.
• Strong background in developing and authoring protocols, methods, and SOPs.
• Excellent communication skills, both written and verbal, with the ability to collaborate effectively across technical and operational activities.
• Working knowledge of statistics and familiarity with tools like R or Python.
• Demonstrated ability to manage multiple projects simultaneously with strong organizational and problem-solving skills.
• Self-motivated and proactive, with a keen interest in experimental design and development.
• Knowledge of GMPs, GLPs, GCPs, and GDPs regulations.

Preferred Experience:

• Expert-level proficiency in Liquid Chromatography and Immunoassays.
• Experience in drafting protocols, methods, and procedures.
• Knowledge or experience with neurotoxin therapeutics.
• Familiarity with change control, deviation, laboratory investigation, and other quality records.

Education:

• Advanced degree in biological sciences or a related field with 5+ years of progressive experience in the biotechnology or pharmaceutical industry.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Science

Industries

• Pharmaceutical Manufacturing