IDAP Commercialization Technical Lead

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Responsibilities

The TSMS Commercialization Technical Lead of Indianapolis Device Assembly & Packaging (IDAP) is responsible for providing technical leadership to commercialization activities at the site.

The scope of the role includes all commercialization of parenteral and dry drug products (DP), Drug Delivery Systems (such as combination products and medical devices), and packaging. Commercialization includes technical transfer and validation of newly launched products or products in the process of launching.

The TSMS Commercialization Technical Lead can be involved with clinical trials and supports all commercialization activities up to first submissions and approval of the DP by providing technical support to ensure processes are in alignment with Lilly Manufacturing Standards of Operational Excellence (MSOE), Lilly Global Quality Standards (GQS), Lilly Quality Standards (LQS), and IDAP commercialization procedures.

The TSMS Commercialization Technical Lead works with internal IDAP teams such as Engineering, Operations, and Quality as well as other local/global teams like Delivery, Device, and Connected Solutions (DDCS), Indianapolis Device Manufacturing (IDM), Regulatory, and others throughout the commercialization process.

Key Objectives/Deliverables:

• Understand the scientific principles required for Device Assembly and Packaging operations

• Provide product and process technical knowledge to identify appropriate manufacturing lines for processing of new products

• Support identification and development of new manufacturing technologies and processes to support commercialization

• Facilitate equipment commissioning and qualification activities, as required

• Lead risk management activities as it pertains to new products (pFMEA)

• Own Tech Transfer strategy for the manufacturing site

• Ensure that an accurate instruction set (tickets and procedures) and PFD describe the process and control strategy for new products

• Drive technical excellence through meaningful specifications, including approval of local specifications and influencing global specifications

• Understand, justify, and document the process validation strategy for new products

• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: tech transfer risk assessments / plans / reports, change controls, regulatory submissions, deviation investigations, stability strategies, validations, procedures, specifications, PFDs, etc.

• Manufacturing site representative for new product regulatory submissions, including authoring and/or reviewing relevant submission document sections

• Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP

• Serve as technical interface with development

• Communicate effectively with process team members, development colleagues, tech transfer team members, and other customers

• Identify opportunities for best practices, and implement improvements to tech transfer processes

Basic Requirements:

• Bachelor’s degree in STEM discipline

• Minimum 4 years experience in GMP Manufacturing preferred (Pharma industry preferred)

Additional Skills/Preferences:

• Technical Writing and Presentation skills

• Clear understanding of cGMPs and risk management

• Good teamwork and interpersonal skills

• Previous experience in TS/MS, Engineering, or Quality

• Previous experience with product commercialization and/or development

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