Manager Analytical Development

RBW Consulting; Massachusetts; On-site; USD 120,000 - 180,000; Full time

Job summary

RBW Consulting in partnership with a biotechnology client is seeking an Analytical Development leader to oversee a diverse portfolio of small molecule and biologics programs. You will lead method development, validation, and transfer, and manage external partners to ensure robust testing and data integrity.

The role drives stability programs, data trending, and technical oversight of CDMOs while supporting regulatory submissions and quality systems to ensure compliance with GMP, ICH, FDA, and

Qualifications

• Extensive analytical development experience across biologics and/or small molecules
• Strong expertise in method development, validation, and stability studies
• Experience managing external laboratories, CDMOs, or outsourced development programs
• Working knowledge of GMP, ICH, FDA, and EMA requirements

Responsibilities

• Leading analytical method development, validation, and transfer activities
• Overseeing release, stability, and in-process testing through external partners
• Managing stability programs and data trending across multiple development programs
• Providing technical oversight of CDMOs and contract testing laboratories
• Supporting regulatory submissions, investigations, and quality systems activities

Skills

Analytical development

Method development

Validation

Stability studies

CDMOs oversight

External labs management

GMP knowledge

Regulatory submissions

Data trending

Quality systems

Job description

We’re partnering with an innovative biotech company seeking an experienced Analytical Development leader to support a diverse portfolio of small molecule and biologics programs.

Key responsibilities include:

• Leading analytical method development, validation, and transfer activities
• Overseeing release, stability, and in-process testing through external partners
• Managing stability programs and data trending across multiple development programs
• Providing technical oversight of CDMOs and contract testing laboratories
• Supporting regulatory submissions, investigations, and quality systems activities

We’re looking for candidates with:

• Extensive analytical development experience across biologics and/or small molecules
• Strong expertise in method development, validation, and stability studies
• Experience managing external laboratories, CDMOs, or outsourced development programs
• Working knowledge of GMP, ICH, FDA, and EMA requirements