Scientist II / Scientist III-Separation Sciences - AR&D
The Scientist II / Scientist III Separation Sciences AR&D position is a regular full-time position at Adello Biologics. The position is located in Piscataway, New Jersey.
Essential Duties and Responsibilities:
· Provide guidance to team members with respect to HPLC/UPLC troubleshooting, method development, method validation, etc.
· Ensure adherence to highest quality and efficiency standards in laboratory operations (cGLP, cGMP)
· Develop, optimize and validate new chromatography methods using literature references and scientific principles.
· Implement and when necessary, optimize compendial test methods.
· Independently write experiment summaries, development reports, technical reports, operation and test method procedure documents, and review documents comprising, but not limited to batch records, standard operating procedures, standard test methods, validation protocols and reports, etc.
· Foster morale and teamwork
· Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 8-12 years industry experience or Master’s Degree in Biochemistry, Biotechnology, Biology with 6-10 years industry experience or Ph.D in Biochemistry, Biotechnology, Biology with 2-5 years’ experience.
SPECIALIZED KNOWLEDGE AND SKILLS:
· Experience with a wide variety of peptide mapping, HPLC and UPLC techniques including RPLC, SEC, HIC, IEX, at a minimum
· Experience in the isolation and enrichment of product- and process-related impurities
· Demonstrated leadership skills
· Excellent communication and technical writing skills
· Experience in method development, as well as method qualification/verification/validation in a GLP/GMP environment
· Ability to multitask technical responsibilities in a fast-paced, dynamic environment is required
· Proficiency with the following software is required: Microsoft Word, Excel, PowerPoint, and Outlook.
· Experience with Empower and/or ChemStation HPLC software programs is required.
· Experience with any or all of the following is considered advantageous: spectroscopy (UV-Vis, CD, and fluorescence), mass spectrometry, DOE software, strong knowledge of statistics.
WORK ENVIRONMENT AND PHYSICAL DEMANDS:
General Work Environment:
- Laboratory and controlled cleanroom space.
- Cleanroom gowning required.
- Standard noise levels expected with laboratory and manufacturing equipment.
- Extended periods of standing and walking while working in the manufacturing areas
- Must be able to lift 15 lbs.
- No special requirements
- High paced demanding environment to meet manufacturing schedules
- Travel not expected.
Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.
Notice To Agency And Search Firm Representatives
Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.