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Summary:
The Bioprocess Operations team within Bioproduct Research and Development (BRD) is responsible for the manufacture of drug substance (DS) within the BRD portfolio. This includes the internal manufacture of monoclonal antibodies, bioconjugates and adeno associated viruses, as well as coordination of DS manufacturing at qualified collaboration partners.
The main purpose of the Advisor - Pilot Plant Process Improvement (K360 Process Team Mentor) is to drive Operational Excellence and Continuous Improvement in the areas of safety, quality and productivity within K360 internal operations. The K360 Process Team Mentor will work closely with Operations and Functional Directors, Leaders, and technical support to enhance the technical capabilities of the department. In addition, the K360 Process Team Mentor will be responsible for working with CMC project managers and K360 operations to ensure appropriate utilization of the K360 facility, and for leading technical feasibility assessments to ensure new platforms or modalities can be accommodated within the facility.
Position Responsibilities:
- Drive prioritization of initiatives across HSE, Quality, operations and broader BRD goals
- Along with K360 operations director, establish and coach process teams in K360
- Lead capability assessments for new modalities or platforms
- Lead development and implementation of new manufacturing technologies in support of the portfolio.
- Lead risk assessments for platform or facility changes and ensure platform and facility risk assessments meet expectations of compliance, safety, and company deliverables through periodic reviews.
- Serve as a Deviation Mentor and Change Management Coach to broader technical team. This includes leading significant investigations as needed.
- Ensure appropriate facility utilization and cost archetypes in coordination with K360 operations, CMC Project managers and K360 management
- Participate in departmental site self-assessments and relevant audits.
- Lead implementation of Data Initiatives in K360
Basic Requirements:
- B.S. in Biology, Chemical/Biochemical Engineering or related field.
- Minimum of 5 years' experience in a GMP environment
- Ability to proactively identify problems and work toward a solution.
- Excellent oral and written communication skills with the ability to interact well in a team environment and across cultures.
- Excellent organization and self-management skills.
- High initiative, flexible and positive attitude.
- Ability to respond to changing priorities and short lead times.
Additional Preferences:
- Knowledge of clinical trial manufacturing operations.
- Experience working on process teams
Additional Information/Requirements:
- Monday through Friday Day Shift
- Some work outside of core hours may be required to enable the delivery of the portfolio
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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$123,750 - $198,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.