Senior Director – Lab Micro

Location Type: Not Specified

 

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$144,000 – $250,800

Key Objectives/Deliverables:

Technical Contributions and Skills

• Utilize knowledge of development, manufacturing, and regulatory process and expectations to develop the analytical control strategy across products.
• Deepen expertise across technical areas/analytical techniques and be sought out for such expertise.
• Supervise direct reports, when assigned, and actively support and enhance team building through the PM process.
• Identify and implement key capability/technology gaps and justify/champion investment.

Business Influence

• Interact with other appropriate laboratories (Analytical Development, QCL, Third Party) and manufacturing personnel for development, training, transfer, or validation of methodologies or new technologies, with a strong initial focus on building capability at new Lilly sites.
• Lead global/cross functional efforts to drive standardization and/or harmonization.
• Drive development and sustain the product control strategy.
• Drives internal business process improvements across multiple GQL groups.

Knowledge Sharing and Mentoring

• Develops individuals within and outside GQL and QC organizations at various sites; coaches and mentors colleagues, both peers and associates.
• Mentor new analysts within GQL, in other laboratories, or at other QC Labs/sites.
• Influence development laboratories to utilize new technologies for product/process monitoring and control. Work with product development teams to improve quality of deliverables for new chemical entities or formulation line extensions.

Examples of Basic Qualifications

• Bachelor’s degree in biology/chemistry, or related field
• 10+ years (B.S.) or 5+ years (Ph.D.) of microbiological quality control experience in a cGMP environment.

Additional Preferences

• Collaborate with Development or Third Parties, as needed to ensure a proper method is developed, optimized/validated, and ready for transfer.
• Execute method development work and implementation of method improvements for marketed products. Examples may include laboratory work, training/transfer of new methods to labs, implementation of new technologies/improve existing technologies change controls, and regulatory submissions.
• Establish relationships (e.g., Development or Third parties) to influence and ensure appropriate development, optimization, or validation of analytical methods.
• Develop, contribute to, implement or improve new or existing technologies, including equipment and software. Own and steward relevant global processes.
• Demonstrated and current experience with multiple analytical microbiological techniques such as bioburden, sterility, microbial identification, specified organism, culture preparation, antimicrobial effectiveness testing, biological indicators, method validation and verification, and rapid/automated microbiology.

Additional Information:

• Overnight travel may be required.
• Position Location: RTP/ Concord, NC USA
• Position reports to the Associate Vice President of AQCO

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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.

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