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Analytical SME & CMC Technical Writer-# 26-12889

US Tech Solutions, Inc.

Ridgefield, CT

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JOB DETAILS
SALARY
$58–$60 Per Hour
SKILLS
Analysis Skills, Analytical Chemistry, Analytical Development, Biotech and Pharmaceutical, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Detail Oriented, Document Management, Documentation, Drug Products, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ICH Regulations, Investigational New Drug (IND), Leadership, Manufacturing, Marketing Authorization Application (MAA), Multitasking, Pharmaceutical Analysis, Quality Control, Regulations, Regulatory Submissions, Research Protocols, Statement of Work (SOW), Support Documentation, Technical Support, Technical Writing, Time Management, Writing Skills
LOCATION
Ridgefield, CT
POSTED
6 days ago
Duration:  12 Months Contract 

Duties:
  • We are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance (DS) and drug product (DP) development programs within External Alternative CMC development (EACD).
  • This contract role combines deep expertise in DS/DP analytical development and quality control to support ongoing DS/DP external CMC development and demonstrated familiarity of Veera RIM system and technical writing capabilities to support documentation and global regulatory submissions (e.g., IND, CTA, NDA/MAA).
  • The successful candidate will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation aligned with global regulatory expectations
Analytical Expertise
  • Provide scientific leadership in phase appropriate external DS/DP analytical development/QC for NCE and NCE-like (e.g., Oligonucleotide) entities, including method development, validation, transfer and lifecycle management
  • Contribute to development of DS/DP phase appropriate specifications and analytical control strategies in collaboration with internal and external teams
  • Contribute to development of DS/DP stability programs and assignment of DS retest period, DP shelf life and material holding times as needed, with internal and external teams to support FIH and following clinical trials
  • Independently propose or review quality agreement, SOW, study protocols/reports, batch/stability data, to support CMC deliverables in a timeline fashion.
  • Prepare and communicate clearly and independently technical plans, updates and deliverables as needed in the form of reports and/or presentations within the internal teams
  • Partner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and quality events and ensure timely, compliant deliverables
CMC Technical Writing
  • Support departmental submission activities by managing documentation workflow workflow in Veeva RIM system
  • Demonstrated working experience in authoring, reviewing and editing (content and format) CTD Module 3 (Drug Substance and Drug Product) documents, in particular analytical related documents.
  • Contribute to preparation of regulatory submissions/briefings and responses to health authority inquiries
Required Skills:
  • Significant working experience (>6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug substance and solid and liquid formulations. 
  • Demonstrated working experience in regulatory submissions 
  • Familiarity with GMP and regulatory guidelines (e.g., ICH, FDA, EMA, USP, EP, etc.)
Preferred
  • Experience in global regulatory submissions (IND, CTA, NDA, MAA)
  • working with external manufacturing or testing partners
Key Skills
  • Strong organization and technical writing skills
  • High attention to detail and scientific rigor
  • Effective communication and stakeholder collaboration
  • Ability to manage multiple priorities in a fast-paced environment
Education
  • Advanced degree (e.g., PhD) is preferred, or Master's and Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or related discipline
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
 
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring. 

About the Company

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US Tech Solutions, Inc.

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