Comrise
The Analytical Scientist will be part of a team of drug development professionals responsible for the continued development and regulatory approval of thin film drug products containing a wide range of therapeutic compounds.
Job Responsibilities Hands-on laboratory analysis of R&D drug substance and drug product samples.
Method development, method transfer and validation of analytical methods developed in-house or from client.
Provide analytical support during pre-formulation, formulation development and manufacture of prototype formulations, clinical trial materials and process scale-up.
Perform characterization, release and stability testing of raw material and drug product samples for conformance to specifications.
Prepare and update/review SOPs for the analytical laboratory.
Observe and maintain compliance with applicable DEA and safety regulations, cGLP/GMP guidelines, and company policies and procedures.
Interact in a team atmosphere, providing expertise in general analytical techniques.
Troubleshooting and repair of minor problems in analytical instruments.
Responsible for laboratory work area housekeeping.
Assist with raw data review, analysis, report writing and laboratory investigations (OOT/OOS).
Ensure that responses to regulatory inquiries are conducted in accordance with regulatory guidelines and in consideration of business implications.
Job Qualifications BS/MS in Chemistry.
Minimum 3 - 5 years of pharmaceutical experience in an R&D analytical laboratory supporting small molecule, protein and peptide development programs.
Strong analytical skills, proven experience in wet chemistry, HPLC, Dissolution, KF, GC and spectrophotometry.
Thorough knowledge of cGMPs, compendia requirements, FDA and EMA regulations.
Experience working with and interpreting regulatory documents such as CFRs, FDA and ICH Guidance documents.
Excellent written and oral communication skills with an ability to prepare and present concise, technical data reports to non-scientific counterparts.
Prior experience with FDA/EMA inspections and audits a plus.
Proficiency in standard office software (MS Word, Excel, PowerPoint).
Must be detail oriented and organized with excellent documentation practices.
Potential temp to perm 5 days onsite
Benefits:
401K, Flexible Schedules, Life Insurance, Medical, Dental and VisionAbout the Company:
ComriseHeadquartered in New Jersey since 1984, Comrise is a staffing, consulting and enhanced search technology company.
For over 38 years, we have delighted our clients and consultants by focusing on customer satisfaction, innovation, and flexible workforce solutions!Our team partners with top-performing companies across the Medical Device, Financial Services, Information Technology and Engineering industries.
Our Cross Border Division connects professionals in North America and Asia with employers both locally and internationally.
Comrise has been awarded Best of Staffing Client Satisfaction for the last nine years.
Specialties:
Managed IT Solutions, Big Data Solutions (Training, Staffing, Consulting, BDaaS), and Workforce Solutions (Staff Augmentation, Recruiting, RPO, Payrolling)Company Size:
100 to 499 employeesIndustry:
Staffing/Employment AgenciesFounded:
1984Website:
https:
//www.
comrise.
com/en.
Estimated Salary: $20 to $28 per hour based on qualifications.
Job Responsibilities Hands-on laboratory analysis of R&D drug substance and drug product samples.
Method development, method transfer and validation of analytical methods developed in-house or from client.
Provide analytical support during pre-formulation, formulation development and manufacture of prototype formulations, clinical trial materials and process scale-up.
Perform characterization, release and stability testing of raw material and drug product samples for conformance to specifications.
Prepare and update/review SOPs for the analytical laboratory.
Observe and maintain compliance with applicable DEA and safety regulations, cGLP/GMP guidelines, and company policies and procedures.
Interact in a team atmosphere, providing expertise in general analytical techniques.
Troubleshooting and repair of minor problems in analytical instruments.
Responsible for laboratory work area housekeeping.
Assist with raw data review, analysis, report writing and laboratory investigations (OOT/OOS).
Ensure that responses to regulatory inquiries are conducted in accordance with regulatory guidelines and in consideration of business implications.
Job Qualifications BS/MS in Chemistry.
Minimum 3 - 5 years of pharmaceutical experience in an R&D analytical laboratory supporting small molecule, protein and peptide development programs.
Strong analytical skills, proven experience in wet chemistry, HPLC, Dissolution, KF, GC and spectrophotometry.
Thorough knowledge of cGMPs, compendia requirements, FDA and EMA regulations.
Experience working with and interpreting regulatory documents such as CFRs, FDA and ICH Guidance documents.
Excellent written and oral communication skills with an ability to prepare and present concise, technical data reports to non-scientific counterparts.
Prior experience with FDA/EMA inspections and audits a plus.
Proficiency in standard office software (MS Word, Excel, PowerPoint).
Must be detail oriented and organized with excellent documentation practices.
Potential temp to perm 5 days onsite
Benefits:
401K, Flexible Schedules, Life Insurance, Medical, Dental and VisionAbout the Company:
ComriseHeadquartered in New Jersey since 1984, Comrise is a staffing, consulting and enhanced search technology company.
For over 38 years, we have delighted our clients and consultants by focusing on customer satisfaction, innovation, and flexible workforce solutions!Our team partners with top-performing companies across the Medical Device, Financial Services, Information Technology and Engineering industries.
Our Cross Border Division connects professionals in North America and Asia with employers both locally and internationally.
Comrise has been awarded Best of Staffing Client Satisfaction for the last nine years.
Specialties:
Managed IT Solutions, Big Data Solutions (Training, Staffing, Consulting, BDaaS), and Workforce Solutions (Staff Augmentation, Recruiting, RPO, Payrolling)Company Size:
100 to 499 employeesIndustry:
Staffing/Employment AgenciesFounded:
1984Website:
https:
//www.
comrise.
com/en.
Estimated Salary: $20 to $28 per hour based on qualifications.
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