Principal Scientist, Drug Product Design (Remote)

Role Summary

Principal Scientist, Drug Product Design. Remote role with location listed as Redmond, WA. Reports to the Senior Director, Drug Product Design. The role involves leading and contributing to drug product manufacturing process development, technical transfer, and GMP manufacturing of biologics, with emphasis on innovation, collaboration, and strategic problem-solving.

Responsibilities

• Dive deep into drug product manufacturing process development, process technical transfer, and GMP manufacturing of biologics, always looking for ways to improve efficiency, reduce risk, and innovate.
• Identify, review contracts, and maintain relationships with existing and future drug product manufacturers.
• Provide technical oversight for drug product manufacturing activities (including person-in-plant responsibilities), bringing fresh perspectives to manufacturing process development and technical transfer that challenge the status quo.
• Collaborate with cross-functional teams and external clients to ensure technical success and uninterrupted supply of drug product. Represent the Drug Product Design function on internal teams and external partnerships.
• Keep up with the latest trends and developments in GMP drug product manufacturing and use knowledge and experience to inspire and influence both internal and external stakeholders.
• Travel: 10-25% to manufacturing sites for client products.

Qualifications

• A recognized expert in drug product manufacturing of sterile dosage forms, including frozen, liquid, and lyophilized formulations in vials, pre-filled syringes, and cartridges.
• A curious problem-solver with knowledge of analytical techniques for product and process characterization enabling continuous learning and growth in a dynamic environment.
• Experience with Quality Management Systems and other GxP systems to support GMP manufacturing.
• A self-starter who is comfortable with ambiguity and thrives in environments where curiosity and experimentation are encouraged.
• Excellent communicator, both verbally and in writing, able to gain alignment and advance project goals in multi-company collaborations.
• Knowledgeable of global regulatory expectations for the development and manufacturing of biologic drug products and biosimilars.

Skills

• Drug product manufacturing expertise for sterile dosage forms and related analytical techniques.
• Cross-functional collaboration and stakeholder influence.
• Regulatory understanding for biologics and biosimilars.

Education

• Not specified in the provided description.