Associate Research Scientist- 1st Shift
Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.Innovating every day.Basic Purpose:
Performs all process validation testing for new R&D and transfer products. Responsible for analytical activities from demo through filing. Will serve as the intermediate between R&D and QC.Essential Functions and
Responsibilities:
Review, and/or interpret method transfer/validation/ verification protocols. Execute process validation testing, including HPLC, GC, and other analyses as required by the protocol. Perform peer audit in notebook, protocol, certificate of analysis, or other documentation as required. Support investigations including troubleshooting and serving as second analyst in analysis. Train QC chemist on new products or techniques as needed. Other duties as assigned by QC Manager Knowledge, Skills, Qualifications and Physical Requirements:
The following describes the general knowledge, skills, qualifications, and physical requirements normally associated with performing the essential functions of this job. In compliance with law Cosette Laboratories will consider varying or modifying these standards to provide individuals with disabilities an equal employment opportunity.Education/Training/Work
Experience:
BA/BS in Chemistry or related scientific field. Previous experience with testing process validations in GMP regulated industry. Must be able to coordinate multiple product analyses concurrently with a high degree of accuracy. Demonstrate knowledge of cGMPs, Safety, OSHA, and 21 CFR regulations/requirements. Demonstrate ability to manage projects while executing work to meet established deadlines. Demonstrate knowledge of technical aspects of validations, method transfers, and be adept in all areas of protocol execution including any necessary troubleshooting. Specialized Knowledge and Skills:
Analytical/technically minded. Ability to multi-task under stress of multiple priorities Ability to clearly convey method requirements to QC chemists. Ability to manage multiple projects/ instruments concurrently. Equipment and Applications:
Microsoft Access, word, Excel, PowerPoint pH Meter Viscometer Microscope Karl Fisher Dissolution Vacuum Oven HPLC GC Headspace Empower Software Distillation and Reflux Techniques Work Environment and Physical Demands (List required PPE's):
Gloves Safety Glasses Lab Coat Faceshield Face Mask Ability to occasionally lift 50 pounds. #J-18808-Ljbffr Recommended Skills Analytical Auditing Filing Ms Access Multitasking Occupational Safety And Health Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3t0g279d0wt5dbm3vf', 'ExternalApply-j3t0g279d0wt5dbm3vf'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
Performs all process validation testing for new R&D and transfer products. Responsible for analytical activities from demo through filing. Will serve as the intermediate between R&D and QC.Essential Functions and
Responsibilities:
Review, and/or interpret method transfer/validation/ verification protocols. Execute process validation testing, including HPLC, GC, and other analyses as required by the protocol. Perform peer audit in notebook, protocol, certificate of analysis, or other documentation as required. Support investigations including troubleshooting and serving as second analyst in analysis. Train QC chemist on new products or techniques as needed. Other duties as assigned by QC Manager Knowledge, Skills, Qualifications and Physical Requirements:
The following describes the general knowledge, skills, qualifications, and physical requirements normally associated with performing the essential functions of this job. In compliance with law Cosette Laboratories will consider varying or modifying these standards to provide individuals with disabilities an equal employment opportunity.Education/Training/Work
Experience:
BA/BS in Chemistry or related scientific field. Previous experience with testing process validations in GMP regulated industry. Must be able to coordinate multiple product analyses concurrently with a high degree of accuracy. Demonstrate knowledge of cGMPs, Safety, OSHA, and 21 CFR regulations/requirements. Demonstrate ability to manage projects while executing work to meet established deadlines. Demonstrate knowledge of technical aspects of validations, method transfers, and be adept in all areas of protocol execution including any necessary troubleshooting. Specialized Knowledge and Skills:
Analytical/technically minded. Ability to multi-task under stress of multiple priorities Ability to clearly convey method requirements to QC chemists. Ability to manage multiple projects/ instruments concurrently. Equipment and Applications:
Microsoft Access, word, Excel, PowerPoint pH Meter Viscometer Microscope Karl Fisher Dissolution Vacuum Oven HPLC GC Headspace Empower Software Distillation and Reflux Techniques Work Environment and Physical Demands (List required PPE's):
Gloves Safety Glasses Lab Coat Faceshield Face Mask Ability to occasionally lift 50 pounds. #J-18808-Ljbffr Recommended Skills Analytical Auditing Filing Ms Access Multitasking Occupational Safety And Health Apply to this job. Think you're the perfect candidate? Apply on company site $('.external-apply-email-saved').on('click', function (event) window.ExternalApply = window.open('/interstitial?jobdid=j3t0g279d0wt5dbm3vf', 'ExternalApply-j3t0g279d0wt5dbm3vf'); ); $(document).ready( function() $(#ads-desktop-placeholder).html(
n
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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