Pay Growth
?
out of 5
Not enough data
Not enough info to score pay or growth
CMC Scientist - Analytical Development (Small Molecule)
Job
Randstad USA
Remote
$120,068 Salary, Full-Time
Review key factors to help you decide if the role fits your goals.
Job Security
?
out of 5
Not enough data
Calculating job security score...
Total Score
65
out of 100
Average of individual scores
Skill Insights
Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.
Job Description
job summary: Are you a seasoned CMC expert looking for a high-impact, flexible role? A top-tier global pharmaceutical leader is seeking a remote Analytical
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. job detailssummary$57 - $58.45 per hourcontractpostgraduate degreecategorylife, physical, and social science occupationsreference53771job details job summary: Are you a seasoned CMC expert looking for a high-impact, flexible role? A top-tier global pharmaceutical leader is seeking a remote Analytical
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
SME & CMC
Technical Writer. This fully remote position requires alignment with East Coast working hours (EST) and offers a premier opportunity to drive analytical strategies and author critical regulatory submissions.location:
Telecommute job type: Contract salary: $57.00 - 58.45 per hour work hours: 9 to 5 education: Doctorate responsibilities: Provide scientific leadership for phase-appropriate external drug substance (DS) and drug product (DP) analytical development, validation, and lifecycle management. Contribute to the development of DS/DP specifications, analytical control strategies, and stability programs for clinical trials. Review and author Quality Agreements, Statements of Work (SOWs), study protocols, and batch/stability data from CDMOs/CROs. Manage documentation workflows and global regulatory submission activities utilizing the Veeva RIM system. Author, review, and edit CTD Module 3 (DS and DP) documents, specifically focusing on analytical sections and Health Authority responses.qualifications:
Required:
Bachelor's or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline (Advanced degree preferred). 6+ years of pharmaceutical/biotech CMC and analytical development experience spanning NCE drug substances as well as solid and liquid formulations. Demonstrated experience in technical writing and authoring regulatory submissions. Strong familiarity with GMP regulations and global guidelines (ICH, FDA, EMA, USP, EP).Preferred:
Proven experience with global submissions (IND, CTA, NDA, MAA). Background working directly with external manufacturing or testing partners (CDMOs/CROs). #LI-MH1 skills: Good Manufacturing Practices (GMP), European Medicines Agency (EMA), Investigational New Drug (IND), New Drug Application (NDA), Marketing Authorization Application (MAA), International Council for Harmonization (ICH), Chemistry Manufacturing and Controls (CMC)Equal Opportunity Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. job detailssummary$57 - $58.45 per hourcontractpostgraduate degreecategorylife, physical, and social science occupationsreference53771job details job summary: Are you a seasoned CMC expert looking for a high-impact, flexible role? A top-tier global pharmaceutical leader is seeking a remote Analytical
SME & CMC
Technical Writer. This fully remote position requires alignment with East Coast working hours (EST) and offers a premier opportunity to drive analytical strategies and author critical regulatory submissions.location:
Telecommute job type: Contract salary: $57.00 - 58.45 per hour work hours: 9 to 5 education: Doctorate responsibilities: Provide scientific leadership for phase-appropriate external drug substance (DS) and drug product (DP) analytical development, validation, and lifecycle management. Contribute to the development of DS/DP specifications, analytical control strategies, and stability programs for clinical trials. Review and author Quality Agreements, Statements of Work (SOWs), study protocols, and batch/stability data from CDMOs/CROs. Manage documentation workflows and global regulatory submission activities utilizing the Veeva RIM system. Author, review, and edit CTD Module 3 (DS and DP) documents, specifically focusing on analytical sections and Health Authority responses.qualifications:
Required:
Bachelor's or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline (Advanced degree preferred). 6+ years of pharmaceutical/biotech CMC and analytical development experience spanning NCE drug substances as well as solid and liquid formulations. Demonstrated experience in technical writing and authoring regulatory submissions. Strong familiarity with GMP regulations and global guidelines (ICH, FDA, EMA, USP, EP).Preferred:
Proven experience with global submissions (IND, CTA, NDA, MAA). Background working directly with external manufacturing or testing partners (CDMOs/CROs). #LI-MH1 skills: Good Manufacturing Practices (GMP), European Medicines Agency (EMA), Investigational New Drug (IND), New Drug Application (NDA), Marketing Authorization Application (MAA), International Council for Harmonization (ICH), Chemistry Manufacturing and Controls (CMC)Equal Opportunity Employer:
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.