Associate Director - Analytical Development, Biologics

POSITION SUMMARY

We are looking for an Associate Director of Analytical Development – Biologics who is organized, self-motivated, collaborative, detail-oriented, has a strong analytical background and knowledge base.  The person filling this role will partner with the Executive Director of Analytical Development/QC – Biologics to execute and support method development and validation, technology transfer, method lifecycle management, ensuring that methods are scientifically sound, robust, fit for purpose and compliant with applicable regulatory requirements. This role requires a pragmatic hands-on scientist who exercises scientific judgement and proactively identifies and resolves technical challenges to meet program milestones. This position is located in Foster City.

JOB FUNCTIONS/RESPONSIBILITIES

• Serve as a key member of cross-functional CMC teams comprising Quality, Manufacturing, and Regulatory representatives
• Lead and support method transfer activities between external sending and receiving laboratories
• Review analytical method validation and transfer protocols and reports
• Provide technical support to receiving laboratories on analytical procedures and instrumentation as required and to ensure successful transfer
• Ensure transferred methods meet predefined acceptance criteria and are suitable for routine GMP testing
• Support risk assessments, gap assessments, and method comparability evaluations in support of method transfer
• Support analytical method related and product trending activities
• Oversee reference standard and critical reagent qualification and inventory management
• Record and report analytical results accurately in worksheets, logbooks, LIMS, or electronic systems
• Review analytical data for accuracy, completeness, and compliance with GMP and data integrity requirements
• Record and report analytical results accurately in LIMS, or electronic systems
• Work with QC and QA to support investigations related to OOS, OOT and OOE, deviations and laboratory incidents
• Follow company SOPs, pharmacopoeia methods, and regulatory guidelines, e.g. USP, EP, ICH, and FDA/EMA requirements

QUALIFICATIONS

Education /Experience:

• BS/MS in Biochemistry, Chemistry, or a Biological Science with 8+ years of industry experience in biologics pharmaceutical manufacturing and testing
• Hands-on experience with analytical instruments, especially CE, HPLC, UV, and LC-MS for biological compounds
• Knowledge of GXP

KNOWLEDGE, SKILLS, AND ABILITIES

• Strong interpersonal skills and ability to collaborate across functions
• Ability to respond effectively to changing priorities, evolving program needs, and unexpected technical challenges
• Experience with technology transfer to multiple locations and countries for clinical and late phase product testing
• Ability to investigate and troubleshoot analytical issues
• Ability to work under deadlines and manage multiple projects
• Experience with stability testing and analytical method transfer/validation.
• Strong attention to detail and accuracy
• Excellent analytical skills and data management skills
• Good documentation and report-writing skills.
• Excellent communication skills for both written and verbal presentations
• Track record in authoring and reviewing of regulatory documentation (e.g. INDs, IMPD, MAAs, BLAs)

The salary range for this position is $190,000 to $210,000USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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