Scientist I, Analytical Development Specialist
1 week ago
We are seeking a highly motivated and detail-oriented Scientist I to join our Process Analytics team within our Analytical Development department at Elektrofi Inc.
Job SummaryThe successful candidate will be responsible for developing, qualifying, and performing analytical methods to support process development testing, and perform process analytics, and release testing of our protein therapeutics.
Key Responsibilities- Develop and qualify phase-appropriate methods for the characterization and release testing of drug products.
- Plan, execute, document and analyze experiments, and present results to a multidisciplinary team.
- Interface with collaborators and contract research organizations (CROs) to facilitate method transfer and method qualification activities.
- Troubleshoot and resolve testing-related issues.
- Maintain accurate records and documentation of test results.
- Regularly perform analytical data review and reporting of results.
- Author SOPs, technical reports, and certificates of analysis.
- Stay current with the latest industry developments and regulatory requirements.
- Maintain safe laboratory working conditions following GLP and EHS guidelines.
- Serve as a subject matter expert in the investigation of out of specification/trend analytical results
- B.S. Degree required with a preferred focus in Analytical Chemistry, Physical Chemistry, Material Science & Engineering or a similar academic background.
- Bachelor's degree with 5+ years of relevant experience, Master's with 3+ years of relevant experience, or entry-level PhD required.
- Excellent critical thinking abilities plus exceptional verbal and written communication skills.
- Demonstrated ability to work efficiently in a fast-paced, collaborative R&D environment.
- Strong background in method development and characterization of protein therapeutics using various analytical techniques:
- Must have working experience with the following techniques: UV-vis spectroscopy, Karl Fischer, Particle Size Analyzer (Laser Diffraction), gas chromatography with flame ionization detection (GC-FID), gas chromatography with mass spectrometry (GC-MS).
- Nice to have experience with: Scanning Electron Microscopy (SEM) with Energy Dispersive X-Ray spectroscopy (EDS), Break-Loose Glide-Force analysis, density meter, rheometer, and Brunauer-Emmett-Teller (BET) by inverse gas chromatography (IGC).
- Strong attention to detail and ability to document experimental work with electronic laboratory notebooks (ELN).
- Experience performing analytical data review and historical data evaluations.
- Experience with writing SOPs and technical documents.
- General knowledge of cGMP, GLP, and regulatory requirements for pharmaceutical industries.
- Familiarity with standard office software (MS Office, Teams, SharePoint).
We are committed to fostering a collaborative and inclusive work environment that encourages innovation and growth. If you are a motivated and detail-oriented individual with a passion for analytical development, we encourage you to apply for this exciting opportunity.
EEOC Statement:
Elektrofi Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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