AS&T Scientist - Late Stage and Commercial experience

Job Description

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Analytical Sciences & Technology (AS&T) Scientist

• Job Location: Boston, MA (Hybrid, 3 days onsite)
• Schedule: M–F standard hours

Description:
We’re seeking an experienced Analytical Sciences & Technology (AS&T) Scientist to join a leading biotech organization in Boston supporting the Cell and Gene Therapy (CGT) portfolio. This role focuses on analytical assay lifecycle management for late-stage and commercial programs, making it ideal for scientists with strong GMP and commercialization experience.

Key Responsibilities

• Lead and support analytical lifecycle activities, including method validation and transfer.
• Author, review, and contribute to technical documents such as method SOPs, study protocols, and regulatory reports.
• Act as Subject Matter Expert (SME) for analytical troubleshooting, quality events, deviations, CAPAs, and change controls.
• Perform data trending, analytical assessments, and lab-based experiments as needed.
• Partner cross-functionally with internal stakeholders and external testing organizations.

Required Qualifications

• Strong knowledge of ICH and GMP regulations.
• Hands-on experience with protein and/or oligo mass spectrometry (MS).
• Reference Standard lifecycle management experience is highly preferred.
• Proficiency in HPLC, UPLC, and/or flow cytometry.
• Excellent technical writing and documentation skills.
• Proven ability to collaborate effectively with internal teams and contract organizations.

Preferred Qualifications

• Experience in cell and gene therapy and/or CRISPR gene editing.
• Prior exposure to late-stage or commercial biologics support.
• Familiarity with critical reagent management and JMP/statistical tools.
• Ability to manage multiple priorities and maintain flexibility in a fast-paced environment.

Education & Experience

• B.S. or higher in Biology, Biochemistry, Analytical Chemistry, or a related field.
• Minimum 8 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent mix of education and experience.

Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

Company Description

Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.