CMC Project Management Associate Consultant - Fixed Duration

For more than 129 years, Lilly has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a “Best in Class” Pharmaceutical company, please review the following opportunity:

CMC Project Management Associate Consultant - Fixed Duration

Chorus is a division of Lilly, operating with a separate portfolio from that of Lilly Research Laboratories. The operating principal of Chorus is to increase the probability of technical success of each molecule in the portfolio by advancing it from candidate selection or later to proof of concept. In addition to a small group of experienced drug developers in Chorus, it requires the expertise of content experts and the development capacity of contract research organizations (CROs). The current portfolio contains a mix of small and large molecules. Chorus contains many of the required functions to enable the design and implementation of drug development namely, toxicology, clinical, CMC, quality, and regulatory. Given the nature of the organization, you will need an entrepreneurial approach and the ability to complete a diverse range of activities.

You will be accountable for leading the implementation of integrated CMC plans for Chorus molecules from candidate selection to proof of concept. You will ensure the delivery of CMC information and clinical trial supplies.

RESPONSIBILITIES:

•Be the CMC member of molecule or program teams within Chorus.
•Independently represent CMC on Chorus molecule program teams.
•Be accountable for the design and implementation of clinical trials.
•Act independently and be responsible for articulating to both toxicology, regulatory, and clinical team members on the appropriate delivery and timing of test article and study drug.
•Communicate the appropriateness of a proposed trial design from a timing or material needs perspective.
•Preparation of the CMC sections of both the clinical investigator brochure and clinical protocols in addition to reviewing those documents in total.
•Be the primary liaison with Lilly procurement for negotiating all Chorus CMC contracts with external contract research organizations.
•Negotiate CMC contracts with external vendors and communicate their implementation with Lilly procurement.
•Assembly of many technical reports and acquired data from external research organizations and distilling the required information into a regulatory document.
•Plan well in advance of writing reports to ensure that the appropriate and necessary data are being collected by external organizations to eliminate the potential for missing items from submission documents.
•Lead the implementation of integrated CMC plans.
•Ensure timely delivery of material for both toxicology and clinical studies.
•Communicate with content experts and multiple external contract vendors.
•Partner with Chorus GMP Quality to ensure all clinical supplies are manufactured, tested, shipped, and stored in full accordance and compliance with the cGMP regulations.
•Preparation of CMC regulatory documentation for submission to allow clinical trial initiation in multiple countries.
•Communicate and provide regular updates to Chorus CMC manager and other appropriate Chorus Managers on all molecule related CMC activities.
•Accountable for interacting with external contractor vendor teams in establishing clear scope of work and the delivery of project milestones on time, on budget, and within scope.
•Identify and monitor critical path activities and develop contingency plans when the project deviates from that path.
REQUIREMENTS
SKILL REQUIREMENTS:

•BS in Chemistry, Pharmacy, or Engineering.
•Demonstrated leadership, preferably in more than one related CMC area.
•Given the diversity of Chorus, experience in multiple disciplines of drug development is required (biologics, drug substance, manufacturing, analytical, quality, formulation, shipping, labeling and storage).
•Ability to articulate across many CMC functions from drug substance process development and manufacturing, drug product formulation development and manufacturing, analytical validation, testing and stability, synthesis and formulation of biologics, aseptic processing, packaging, labeling, shipping and storage.
•Drug development experience with many molecules of varying degrees of complexity.
•At least 5 years experience in cGMP related CMC drug development or manufacturing.
•Full understanding of the cGMPs to enable delivery of clinical trial supplies according to cGMP standards.
•Strong teamwork/interpersonal skills and a demonstrated ability to influence at many levels across many disciplines, both externally and internally.
•Strong communication skills.
•Demonstrated project management skills.
•Proficient with Microsoft Project.
•Previous experience with SAP.
•Masters in Project Management, PMP certification, or MBA would be useful.
•Excellent project management skills.
•Expertise in many scientific disciplines.
•Excellent communication skills.
•Extensive experience working on outsourced projects with external contract research organizations on the design, development, implementation and timely delivery of CMC milestones.
•Legal or contracting experience.
•Ability to negotiate and articulate scientific, timing, financial, legal and intellectual property requirements of each contract with external contract research organizations.
•Prepare CMC sections of regulatory documents (INDs, CTAs) for submission to multiple regulatory agencies.

This position is not permanent. It has a fixed duration of up to 4 years.

Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs more than 44,000 individuals worldwide. Lilly currently conducts research in more than 60 countries and markets products in 143. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.

Lilly earns consistent and wide recognition for creating an exceptional work environment:

•One of the 100 Best Companies to Work for in America (six consecutive years) by Fortune magazine.
•One of the Best Companies for Working Mothers (in the top 10 for the fifth time in nine years) by Working Mother magazine.

ELI LILLY AND COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER