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Date Posted: 7/24/14

Client:  Eli Lilly

Job Title: Associate Senior Consultant Engineer

Location: Indianapolis, IN, USA - 46204

 

Company Overview:

Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and development and we also invest in our employees – in competitive salaries, training and development, and health.

The pharmaceutical industry is a complex, rapidly changing environment and we are looking for highly capable leaders to help us continue bringing innovation to patients.

If you are interested in being considered for employment at Lilly, we encourage you to review the following opportunity.

 

Responsibilities:

The Packaging and Device Design and Development Division within the Lilly Research Laboratories is an integrated drug development and delivery organization which spans the life cycle from candidate selection to submission and post-approval for both small molecules and biologics (peptides and antibodies). This organization is focused on:

Improving patient outcomes thru optimization of drug product design and delivery experience Delivering intentionally designed, safe, environmentally sustainable, and reliable drug products and manufacturing processes consistent with QbD (Quality by Design) concepts Developing primary container, device, and packaging platforms to optimize delivery of material for both clinical and commercial supply The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results and follow established engineering ,design, and development, processes .

Individually, the Associate Senior Consultant Engineer for Packaging Development:

  • Contributes to research projects and programs focused on development of biologic and solid oral products for clinical and commercial use.
  • Work may be conducted independently or more frequently, as part of a product development team consisting of other engineers, scientists (pharmacists and chemists), and technicians.

 

Key Objectives/Deliverables:

Contribute to the development of pharmaceutical products with following responsibilities:

  • Design and develop clinical and commercial container closure/packaging systems that enable clinical trial materials and commercial supply along with a robust registration data package.
  • Design materials testing protocols that will evaluate the basic material properties used in primary container closures.
  • Assess projects for design and product risks using a materials/mechanical engineering/first principles approach.
  • Clearly communicate relevant product and process risks and understanding to management to enable sound business decisions.
  • Help to develop novel and robust container platforms and/or integrate such technologies into the portfolio to meet key outcomes.
  • Prepare and review the appropriate portions of regulatory documents (IND/CTX, CTD, and annual updates) and key technical reports.
  • Enhance Lilly’s professional image and competitive advantage through patents, presentations, publications and professional activities.
  • Identify and support technical, productivity, and other initiatives, and influence key technical partners to maintain alignment.
  • Interact with third parties for packaging design and testing.
  • Stays abreast of relevant new and current technologies, capabilities, and regulatory expectations, guidelines, and requirements; effectively share this knowledge with others; and identify opportunities for implementation.
  • Ensures individual and departmental compliance with the laws, regulations, guidelines, procedures, and practices governing drug research and development, including the departmental and corporate standard operating, good manufacturing, and safety procedures.
  • Ensure that people and their environment are safe and that company policies concerning safety are followed.

 

Basic Qualifications:

  • Ph.D. in Materials Engineering or Mechanical Engineering

 

Additional Skills/Preferences:

  • Expertise in mechanical testing of materials, fundamental understanding of materials degradation mechanisms (embrittlement, corrosion, stress-enhanced corrosion, chemical interactions with materials, and so on)
  • Understanding of finite element analysis
  • Prior experience in pharmaceutical or consumer products is desirable, with a focus on pharmaceutical packaging

 

Additional Information:

  • Limited Travel may be required

Lilly is an EEO/Affirmative Action Employer, and does not discriminate on the basis of race, gender, protected veteran status, disability or any other legally protected status.

 

Apply online at:

https://xjobs.brassring.com/TGWebHost/jobdetails.aspx?partnerid=25428&siteid=5645&Areq=11745BR


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