Director, CMC Biologics

Summary

The Director, CMC will lead biologics development and manufacturing to deliver clinical trial supplies across multiple clinical studies.

Responsible for directing technical aspects of the biologics process development and manufacturing activities at contract manufacturers organizations (CMOs) and consultants including development, scale-up, technical transfers, validation, delivery of launch supplies.  Daily activities such as on-going manufacturing support, process improvements, analytical development determination and development, and technical guidance both internally and externally.  Responsible for coordinating manufacturing timelines in support of clinical/non-clinical studies and commercial launch.

Support the CMC team in writing Quality sections for global regulatory filings and also provide support of business development activities and due diligences. 

Responsibilities

• Responsible for leading and overseeing all aspects of the manufacture of products at CROs and/or CMOs around the world and ensures adherence to project timelines to support clinical and/or commercial supply in line with business objectives.
• Reviews and provides oversight of all documentation related to the production of the product including but not limited to:development, scale-up and validation protocols/reports batch records, deviations, process excursions, analytical methods, protocols and reports.
• Contributes in setting up specifications for starting materials, intermediates and drug substance and product.In conjunction with the CMO and other groups adjudicates deviations and leads or conducts a root cause analysis and implement proposed corrective actions at CRO/CMO.

Experience and Qualifications

• PhD highly preferred with a minimum of 10 years of experience in biologics development, pilot plant, biologics development and manufacturing operations for pharmaceutical APIs (drug substances).
• Bachelor’s or Master’s degree in Biology, Microbiology, Chemical Engineering or related field with a minimum of 12 years of experience.
• Demonstrated scientific knowledge relevant to development and manufacture of biologic drug substances and products with understanding of analytical techniques required for phase appropriate development.
• Must have demonstrated experience in managing and influencing diverse project activities with third party manufacturing facilities at different geographical locations.
• Strong project management experience with cross-functional team leadership and participation skills.
• Requires strong understanding of technology transfer; cGMPs, FDA, EU, ICH guidelines; as well as CMC content of regulatory submissions.

Skills and Abilities

• Self-starter who can work independently and can prioritize tasks.
• Strong communication skills, (both written and oral) including presentations to senior management and external audiences and experts.
• Strong understanding and working knowledge of cGMPs for biologics pharmaceutical development and operations.
• Leadership capabilities for cross functional teams.
• Ability to work across locations and time zones; must be able to travel approximately 25% including international travel.

The expected base pay range for this position is $185,000 - $225,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.

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