Senior Associate Scientist, Specifications

Overview

We are seeking a Senior Associate Scientist, Specifications to support specification development and lifecycle management for drug substances and drug products in a GMP environment. This role will work cross-functionally to ensure specifications, stability data, and regulatory documentation meet company and regulatory standards.

• Initiate and manage specification change controls within a GMP environment.
• Review technical data and author and/or review technical documentation.
• Author and review SOPs and protocols in compliance with internal policies and regulatory requirements.
• Contribute to analytical and stability sections of regulatory submissions.
• Assist in preparing responses to regulatory agency questions and requests.
• Perform specification assessments for existing products and new molecules in development.
• Maintain platform and program-level specification documents.
• Provide technical and scientific support to cross-functional teams as needed.

• QA or Regulatory experience within a GMP environment.
• QC laboratory experience.
• Strong working knowledge of GMP regulations.
• Solid understanding of chemistry principles.
• Experience reviewing and interpreting technical data and documentation.

• BS or MS in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline.

• Minimum of 2 years of relevant professional experience preferred.
• Open to candidates with 10+ years of experience who bring strong technical depth and leadership capability.

• Experience conducting stability studies in accordance with ICH guidelines.
• Hands-on experience with HPLC and physico-chemical test methods.
• Experience with Veeva and/or other electronic data processing systems.
• Statistical analysis experience.
• Oligonucleotide experience strongly preferred; experience with oligosaccharides or proteins is also acceptable.

• Strong team player who collaborates effectively across functions.
• Proactive, self-motivated, and comfortable working independently.
• Detail-oriented with strong analytical and problem-solving skills.
• Interest in continuous improvement and process optimization.
• Excellent written and verbal communication skills.
• Comfortable preparing and delivering technical presentations.

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

Advantage Technical connects top talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities. Advantage Technical is an E-Verify employer.