Job Description

Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines, this position has the following tasks and duties.

Responsibilities

• Provide technical oversight for spray dry and solid dosage manufacturing processes, leveraging a strong technical foundation and previous experience supporting these processes.

• Participate in resolution of technical issues, including those related to control strategy and manufacturing.

• Authoring of deviations and change controls.

• Build, manage, and maintain internal and external relationships, site management, development and central technical organization, and cross-functional teams.

• Ensure that manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state.

• Understand, justify, and document the state of process validation with data that evaluates the capability of the manufacturing process to meet its stated purpose.

• Maintain processes in a state of compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance.

• Support ongoing manufacturing at External Partners through process monitoring, issue response, and process improvements where necessary.

• Work cross-functionally within the site and other functions to deliver on technical objectives.

• Operate with 'Team Lilly' mindset, demonstrating a collaborative approach and positive attitude toward change.

• Comply with all site training, policies and procedures.

Requirements

• Bachelor's degree (minimum) in scientific disciplines of Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering.
• 3+ years of demonstrated hands-on working experience and proficiency with spray dry and/or solid dosage manufacturing.
• Strong understanding of regulatory requirements, their application, and expectations in a manufacturing environment (cGMPs and applicable global regulatory guidance).
• Proficient in data management practices across manufacturing operations.
• Proven ability to effectively communicate and influence across diverse teams.
• Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects.
• Available to support 24/7 operations and issue resolutions across multiple time zones as needed.
• Excellent technical writing capabilities and documentation in English, and communication skills.
• Ability to manage multiple priorities and work independently with limited supervision.

Benefits

• Contract positions with possible extension.