- Analytical method development (HPLC, GC, Dissolution) for raw materials, intermediates, drug substances (APIs) and drug products, and qualification/validation of such methods
- Analyses of APIs and related materials (raw materials, intermediates, mother liquors)
- Analyzing drug products (tablets, capsules, solutions, syrups) and related materials (blends, granulations, cores)
- Supporting analysis geared toward understanding drug-excipient interactions
- Troubleshooting and problem-solving of synthetic processes from bench to pilot scale
- Designing experiments to characterize physico-chemical properties of APIs and drug products.
- Impurity isolation and identification by chromatographic and spectroscopic techniques
- Preparing reports and maintaining documentation of testing results
- Performing maintenance and calibration of analytical testing equipment
- Analyzing and re-certifying analytical reference standards and reference materials
- Operating analytical testing equipment including HPLC, GC, IR, UV/Vis, TGA, DSC, NMR, MS and autotitrator
- Working with CROs to initiate, track-progress and complete projects
- Directing and supporting [internal Sepracor, CRO or CMO] method transfer and troubleshooting when necessary
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
Education
Ph.D. in Chem/Analytical Chem with 0-2 years of related experience. MS degree in Chem/Analytical Chem with 2-4 years of related experience. BS/BA in Chem/Analytical Chem, or related field, with 5+ years of pharmaceutical analysis experience.
Experience
Demonstrated ability in the development and validation of analytical methods for the testing and characterization of pharmaceutical substances. Analytical skills should include: HPLC (isocratic, gradient), GC, thermal analysis, IR, UV-vis, titrimetry, chiral analysis, and general wet and compendial techniques. Additional experience (e.g., NMR, MS, statistics, organic synthesis, process chemistry support, use of Drylab, etc.) is clearly a benefit. Knowledge of GLP/GMP requirements. Knowledge of regulatory requirements for the submission of analytical data to support IND/NDA filings is desirable. Demonstrated problem solving and data analysis abilities required. Demonstrated leadership, written/verbal skills, and good organizational skills are required.
Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.
Job Details |
Job Location |
Candidate Application |
| Employer: Aerotek Scientific | Address: 100 Unicorn Park Drive | Contact: Jelena Raguz |
| Job Type: Full-time | City: Marlborough | |
| Experience:Any | State: Massachusetts | E-mail: jraguz@aerotek.com |
| Education: Any | Zip Code:01752 | Online: Website Link |
Rate: Based on experience.
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