Consultant II

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and develop stable formulations for high concentration subcutaneous dosage forms.

• Aid clients in conducting the appropriate experiments to enhance lyophilization processes, ensuring product stability and effectiveness.

• Oversee the transfer of formulation design to reliable CDMO partners and prepare all essential comparability protocols to facilitate success.

• Guarantee that all analytical activities adhere to current regulatory standards (FDA, EMA, and ICH).

• Compile and assess regulatory submissions, including INDs and CTAs, with an emphasis on Drug Product.

• Collaborate efficiently with CMC teams, including analytical development scientists, drug substance scientists, quality assurance, and regulatory affairs.

• Clearly convey drug product gaps and development strategies to stakeholders, ensuring alignment on project objectives.

• Assist in all stages of clinical development by offering formulation development and design to support decision-making.

• Engage in project meetings and contribute to the creation of clinical trial materials.

• Handle multiple projects concurrently, ensuring timely delivery of formulation results while meeting project timelines.

• Guide junior staff and offer insights on formulation design and regulatory requirements.

⛳️ Requirements

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or a related field is preferred. Equivalent experience will be considered.

• At least 10 years of experience in formulation development, focusing on lyophilization drug products and high concentration dosage forms for subcutaneous delivery.

• Strong grasp of regulatory guidance and experience in preparing regulatory submissions.

• Demonstrated ability to work collaboratively within CMC teams.

• Exceptional interpersonal and communication skills to foster collaboration across departments.

• Capability to work independently with minimal supervision and manage time efficiently.

• Willingness to occasionally travel to client sites for meetings and project discussions.

🏝️ Benefits

• Flexible paid time off

• Company-paid holidays

• Flexible working hours

• Remote work options for most roles

• Office locations available in Greater Boston; San Diego, CA; Boulder, CO; and India.