CMC Lead - Pharmaceutical Development

What You'll Do

Provide strategic pharmaceutical development guidance as the CMC lead to cross functional project teams.

Develop robust formulations and manufacturing processes to support development and rapid registration of QED products.

Review development and manufacturing programs at CRO’s/external vendors to ensure compliance with agreed proposals, quality standards and timelines. Review external data.

Manage drug forecasts and any associated transactions

Integrate and liaise effectively with CMC team

Provide formulation and Clinical supply expertise/support in the preparation of regulatory submissions (e.g. IB, IND, NDA).

Responsibilities

Ability to work effectively and collaboratively on cross functional project teams, in a fast-paced, dynamic environment under tight timelines.

Develop complex formulation for pediatric indications.

Work effectively with CDMO's.

A team player, functional leader, effective listener, clear communicator and quick learner.

Clear, concise communication style with ability to interact internally and externally.

Willing to “roll up his/her sleeves and do what it takes” to achieve critical program deliverables.

Hands-on experience in clinical trials management/study conduct, formulation development and clinical trial manufacturing.

Knowledge of commercial manufacture

Where You'll Work

Remote with 30% travel expected

Who You Are

PhD or advanced degree in Chemistry or Pharmacy with 7+ years of bio/pharmaceutical industry experience in formulation development and Clinical Supply.

Expertise in formulation in addition to knowledge of PK/PD principles, ADME concepts, and regulatory documentation and authorship.

Knowledge of import/export sensitivities.

Demonstrated ability to manage Clinical Supply, Formulation development and manufacture at CRO’s.

In-depth knowledge and understanding of CMC Regulatory requirements for US and EU are required