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Associate Director OR Director, Bioanalytical Sciences

CMC Operations – Monrovia, California
Department CMC Operations
Employment Type Full Time

This position will interact with multiple levels of the organization.  Candidate must have the ability to approach issues from both a strategic and tactical perspective.  Additionally, the successful candidate must demonstrate business acumen, communication/presentation skills, and the ability to influence others.  This includes the ability to effectively drive both internal and external (in partnership with contract development/manufacturing organizations) team discussions, through active engagement of multiple client relationships supporting various components of the product supply chain.

Job Duties include:

Conduct and partner with vendors to support the analytical and bioanalytical needs of clinical development projects; managing timelines and workflows effectively.

Provide scientific insight into biologics characterization

Development of regulatory documents / Module 3 analytical content in collaboration with Regulatory Affairs CMC, serving as the analytical lead for associated regulatory interactions.  Respond to analytical questions from regulatory agencies.  

Conduct and coordinate drug substance / API characterization, drug product characterization, and in-vitro testing as needed.

Participate in bioanalytical activities including managing the development, qualification, and validation of methods.

Drive innovative approaches to the development, evaluation, and negotiation with regulatory agencies of analytical control strategies including specifications and stability.

Establishment and management of associated reference standards and reference materials.

Adopting and driving innovative analytical techniques and strategies that translate into robust commercial analytical testing platforms.

Perform other analytical duties as assigned

Qualifications/Requirements:

Ph.D. in (bio)chemistry or related field

Minimum of 8 years of progressive experience in analytical sciences within the biopharmaceutical industry

Strong understanding of drug development process and related regulations; including cGMP requirements

Strong knowledge of biologics characterization techniques

Experience with HPLC, Immunological, and MS techniques

Experience with stability and comparability studies

Experience with procedures leading to US and international regulatory approvals

Organized and detail-oriented

Excellent communication and presentation abilities

Proficiency with MS Office suite

Ability to travel up to 20% as needed

Preferred Qualifications:

Broad experience leading Analytical Development activities with GMP responsibilities

Demonstration of driving analytical innovation

Experience working with or for a Contract Manufacturing Organization (CMO)

Previous experience leading project teams or managing direct reports

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  • Location
    Monrovia, California
  • Department
    CMC Operations
  • Employment Type
    Full Time
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