LOCATION: Indianapolis, IN

The Aseptic Process Engineer- Syringe Filling provides technical leadership and high-level engineering expertise for all syringe filling and inspection operations in the Parenteral Plant.

KEY OBJECTIVES/DELIVERABLES:

Coach and mentor engineering associates in aspects of syringe filling and handling, including: process knowledge, problem solving, project management, and engineering design.  Provide companywide syringe process expertise.  Identify syringe process knowledge gaps that impact equipment and process capability.  Review and track key syringe filling line process metrics.  Improve throughput and optimize the syringe filling
line(s)

MINIMUM REQUIREMENTS: Bachelor’s Degree in Engineering or related field.  Minimum of 10 years syringe filling experience (Design or operations of syringe filling / processing equipment).   Qualified candidates must be legally authorized to be
employed in the United States. Lilly does not anticipate providing sponsorship
for employment visa status (e.g., H-1B or TN status) for this employment
position.

ADDITIONAL SKILLS/PREFERENCES: Technology Glass handling and/ or glass fractographical experience.

OTHER CONSIDERATIONS:  Day Shift, possible after-hour support.

Project Delivery and/or Plant Shutdown may coincide with
company holidays.

Occasional travel may be required for training,
conferences, capital projects, and support additional syringe filling sites.

Chemicals Manufacturing

Location:  Indianapolis, Indiana

Ideal Candidate:

5+ to 7 years of experience
Management Experience Required – No
Minimum Education – Bachelor’s Degree
Willingness to Travel – Occasionally

The Chemical Engineer is responsible for preliminary and final process design work for new chemical manufacturing facilities and improvements to existing facilities. This includes performing detailed design calculations, identifying opportunities for process optimization, recommending process design changes, and assisting with the implementation and start-up of those recommendations. Some travel to our manufacturing sites will be required. 

Duties and Responsibilities:

    * Develop preliminary scope and plan for new projects, estimate preliminary project costs and    benefits.

    * Prepare new, or modify existing plant Process Flow Diagrams (PFD’s).

    * Complete detailed Material and Energy Balances for new or modified processes.

    * Prepare new or modified Process and Instrumentation Diagrams (P&ID’s).

    * Size and specify new process equipment and re-rate existing equipment for new capacities or services.

    * Size and specify Safety Relief Devices and vent systems.

    * Prepare new, or modify existing Plant Operating Procedures to accurately reflect project scope,

      control philosophy, and objectives.

    * Work with plant operating personnel to troubleshoot plant operation issues, especially when associated with project implementations.

    * Work on Continuous Improvement Projects as identified or needed. Areas of emphasis include:

      manufacturing cost reduction, capacity improvements/cycle time reductions, energy and waste

      reduction, and process reliability.

Education and Experience Requirements:

    * Minimum of a Bachelors Degree in Chemical Engineering.

    * 5 – 10 years experience in process design or process engineering.

    * Fundamental knowledge of continuous and batch chemical operations including reaction,

      distillation, heat exchange, solids handling, utilities and process control.

    * Problem solving skills including the ability to analyze technical data and make creative and

      balanced decisions.

    * Strong written and verbal communication skills.

    * Self motivated with the ability to take initiative and work successfully in cross functional teams.

    * Flexibility to work in both office and operating plant environments on a wide variety of activities.

    * Working Knowledge of process safety tools (PHA, LOPA, MOC, Root Cause Analysis, etc.).

Preferred Skills and Competencies:

    * Process simulation experience (Aspen Plus and/or PD-Plus, hydraulic modeling software).

    * Familiarity with Six Sigma processes.

    * Prior experience conducting process plant optimization

Location:  Indianapolis, IN

Ideal Candidate: 

2+ to 5 years of experience
Management Experience Required – No
Education – BS or MS (This is not a PhD position)
Willingness to Travel – Occasionally

This cross functional position is an integral part of the Protein Optimization Characterization lab within the Protein Optimization Team of Biotechnology Discovery Research, which is responsible for generating, characterizing, and optimizing biotherapeutics from lead generation to lead optimization and preclinical development. We are seeking a motivated research associate with a BS or MS degree in biochemistry or related field that exhibits a broad analytical aptitude who can function in a highly collaborative environment performing analytical purification and biochemical characterization of proteins/peptides in a multidisciplinary team focusing on optimizing therapeutic properties of biotherapeutics.

KEY OBJECTIVES/DELIVERABLES:

The individual will perform mass spectrometry of proteins and peptides to support multiple drug discovery programs.

Additionally, they will perform appropriate protein sample preparation methods (e.g. in gel digestion, in solution digestion, protein/peptide separation on HPLC, etc.).

The individual will be responsible performing intact mass analysis, peptide mapping and LC MS/MS analysis.

Additionally the successful candidate will operate, maintain and troubleshoot liquid chromatography, mass spectrometers and auxiliary instrumentation.

The individual will also employ scientific background and communication skills to professionally support investigators by recommending sample preparation methods, advising in experimental design, and assisting in the analysis, evaluation, and interpretation of experimental results in conjunction with other staff within the Protein Optimization Team.

MINIMUM REQUIREMENTS:

A BS with more than two years of research experience or MS degree in protein biochemistry or related field is required.

This position requires knowledge and experience of HPLC, LC-MS, and LC MS/MS-based protein analysis and hands-on experience with purification and characterization of proteins

Characterize proteins by performing intact mass analysis, peptide mapping and LC MS/MS

Analytical biochemistry technique experience

Location:  Indianapolis, IN

The Ideal Candidate:

5+ to 7 years of experience

Management Experience Required – Yes

Minimum Education –Master’s Degree

 Willingness to Travel – Occasionally

The Clinical Trial Support Operations (CTSO) team is responsible for providing clinical trial study drug management services and supporting the Demand Management side of the business by providing the following support services:  Distribution, Study Order Management and Ownership, and Business Systems Support & Operations. The Clinical Trial Support Operations team partners with appropriate business partners to ensure study order ownership and support to successfully enable clinical research.

The Director is responsible for developing and implementing the strategy for the Clinical Trial Support Operations department, effectively managing the capacity and capabilities of the organization, ensuring strong cross functional partnerships exist in support of the portfolio, and overseeing compliant business processes and deliverables that lead to the on time delivery of Investigational Products that enable Clinical Research.  The Director provides appropriate oversight to ensure full compliance with GxP, corporate standards/policies/procedures, operational excellence, continuous improvement, personnel development and overall leadership.

KEY OBJECTIVES/DELIVERABLES:

Execute all position responsibilities in a way that integrates ethics and compliance and follows all applicable regulations, the Corporate Integrity Agreement, The Red Book, and policies related to job content.

Management

• Accountable for the global business operation process and execution of the CTSO group
• Provide leadership, direction and oversight for -50 people in Indianapolis, Indiana and Brussels, Belgium
• Organize the department so as to reach the fixed objectives.  Recruit the necessary employees and ensure their training.  Foster the development of technical and organizational expertise.  Forecast adequate budgets and manage the department accordingly.
• Ensure that CT material is produced and supplied on time and in compliance with the quality standards and regulatory requirements (FDA, EMEA, ICH)
• Ensure the appropriate facilities, buildings and equipment are available
• Develop effective relationships with the customers and business partners
• Accountable for delivery of information and services to support the global clinical development strategy.
• Drive continuous process improvement and increased efficiency
• Accountable for all aspects quality and compliance
• Effectively manage all communication channels
• Anticipate and resolve issues with the organization and key stake-holders
• Accountable for operational leadership and excellence
• Accountable for development and communication of objectives as well as execution against the objectives
• Accountable for ensuring development of operations skills and capabilities.
• Accountable for implementation and utilization of all supply chain management principles and practices.
• Strategy
• Develop the Vision and associated strategy and plans to successfully deliver all CTSO responsibilities
• Responsible for contributing to and leading the organization to deliver the CTMS vision and strategy.
• Foster and support continuous process improvements
• Support all aspects of the CTMS transformation agenda

External Focus

• Maintain and foster contacts with the other global functions in Indianapolis and ELECTS (CTMM, outsourcing, packaging, quality, manufacturing, etc.)
• Create relationships with customers and external organizations or other pharmaceutical companies (benchmarking).
• Leverage the academic environment to foster innovation.
• Promote the participation of employees in external activities, congresses, seminars that will allow them to exchange professional information.
• Actively manages relationships with external business partners to ensure a positive and productive working environment and enable a FIPNET working environment 
• Provide an external focus through appropriate interaction with other departments; seek to understand trends in the CT supply business.

MINIMUM REQUIREMENTS:

B.S. in Scientific, Operations or related field with 7-10 years experience in pharmaceutical drug development with expertise in at least 1 of the following areas: Product Research and Development (PR & D), Manufacturing, Clinical and 5-7 years experience in people management

OR

Advanced degree (e.g., PhD, PharmD, M.S. Management, MBA) with 5-7 years experience in pharmaceutical drug development with expertise in at least 1 of the following areas: Product Research and Development (PR & D), Manufacturing, Clinical and 3-5 years experience in people management