Associate Director, Technical Operations (Analytical Development-Biologics)

This role will lead operational priorities where safety, quality, compliance, and execution discipline are central to success. You will collaborate with field leadership, support functions, and cross-functional stakeholders to improve accountability, service delivery, and operational consistency. The position offers the opportunity to influence operational scale, customer outcomes, and organizational performance within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Manage method development, validation, and transfer for biologics at CDMOs/CROs
• Oversee specification setting for drug substances and drug products
• Author and review analytical method validation protocols and SOPs
• Manage the reference standard program for drug substances and products
• Assist in OOS and OOT investigations and recommend corrective actions
• Act as technical expert for regulatory submissions related to analytical packages
• Provide scientific support to ensure compliance with regulations

Qualifications

• B.S. in chemistry, biochemistry, pharmaceutical science, or related field required; M.S. preferred
• 8+ years of experience in analytical development of biologics, preferably in late-stage drug development
• Direct experience with HPLC, CE-SDS, cIEF, potency bioassays, peptide mapping, ELISA, and LC-MS required; PEGylated and/or lyophilized product experience a plus
• Strong background in analytical method development, validation, and transfer, preferably at CDMOs/CROs
• Proven knowledge of FDA, ICH, and EU regulatory requirements

Benefits

• Comprehensive premium health offerings for employees and dependents
• Financial benefits including retirement plans with employer match
• Generous paid time off and employee support programs
• Life insurance and disability coverage available
• Wellness programs to promote employee well-being

Pay

$150,000 – $195,000 annually