What are the responsibilities and job description for the Scientist Senior position at Aditi Consulting?
Payrate: $ 40.00 - $ 45.00/hr.
Job Details:
The Senior Scientist will work closely with a team of analytical & bioanalytical chemists, organic chemists, engineers and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for manufacturing processes and products. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance practices and ensure success of the commercial and clinical portfolio.
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
Pay Transparency:
The typical base pay for this role across the U.S. is: $ 40.00 - $ 45.00 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.
#AditiConsulting
Job Details:
The Senior Scientist will work closely with a team of analytical & bioanalytical chemists, organic chemists, engineers and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for manufacturing processes and products. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance practices and ensure success of the commercial and clinical portfolio.
Top 3 Must Have Skill Sets:
- Define analytical control strategies and implement methodologies for late stage programs.
- Collaborate closely with drug substance and drug product Process Development and Quality colleagues.
- Collaborate with cross functional teams to facilitate activities at manufacturing and testing sites (contract and internal).
Day to Day Responsibilities:
- Strong understanding of analytical methods with an emphasis on small molecules
- Experience in a wide variety of analytical techniques, including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, potency, etc.
- Developing and implementing methods for in-process testing, release and stability testing.
- Familiarity with analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
- Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
- Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
- Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines
- Solid communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
- Working well in cross-functional teams, and across various geographic locations in different time zones
- Excellent technical writing skills and attention to detail in data review, authoring methods, specifications, technical reports and regulatory filing documents
Pay Transparency:
The typical base pay for this role across the U.S. is: $ 40.00 - $ 45.00 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.
#AditiConsulting
Salary : $40 - $45
