Sr. Director - Quality Control Laboratories

Initial Therapeutics, Inc.; Huntsville (AL); On-site; USD 156,000 - 228,800; Full time

Benefits offered by this job

401(k) participation

Comprehensive benefit program

Company bonus eligibility

Job summary

Initial Therapeutics, Inc. is seeking a Sr. Director – QC Laboratories in Huntsville, Alabama, to provide leadership for quality laboratories and ensure compliance with GMP standards. This role includes building a high-quality organization and overseeing the implementation of analytical capabilities at a new manufacturing facility.

The ideal candidate will have extensive experience in analytical operations and quality systems, with a strong background in recruitment and personnel development. This position offers a salary between $156,000 and $228,800, with additional benefits.

Qualifications

• Minimum of 10 years supporting complex analytical testing.
• 2+ years working in a GMP/cGMP environment.
• 5+ years of leadership experience.

Responsibilities

• Build a high-quality organization in support of Quality Laboratory Operations.
• Maintain GMP compliance in all Laboratory Operations.
• Recruit new talent and develop site capabilities.

Skills

Analytical operations expertise

Leadership experience

GMP/cGMP knowledge

Interpersonal skills

Technical writing ability

Communication skills

Education

Bachelor’s degree in chemistry, microbiology, engineering, or related discipline

Tools

Microsoft Office products

Job description

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.

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 35,000 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.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Huntsvilles Alabama. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the Lilly Site leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

The Sr. Director – QC Laboratories will provide administrative leadership for the quality laboratories and ensure appropriate capabilities and business processes are developed at the site. The role will define and lead the organization that will support the quality control and analytical laboratories in support of the site and Lilly’s growing pipeline. Within quality control, a state-of-the-art facility will utilize the latest in automation to further the analytical capabilities. These capabilities include everything from on-line in process testing through stability and ongoing process monitoring. The analytical capabilities team will consist of high-level scientist focused on the implementation/transfer of new modalities, proposal, and implementation analytical process improvements, along with the establishment of a center of excellence for molecule characterization. This position involves working cross functionally within the site and across the network to develop the strategic functional capabilities needed to support the mission of the site.

The individual in this role must have expertise in analytical operations and quality systems and a demonstrated ability to develop and lead large teams, lead leaders within an organization, and influence across the networks and with global organizations.

Responsibilities:

Business Support

• Build a high-quality organization in support of Quality Laboratory Operations
• Maintain GMP Compliance in all Laboratory Operations
• Deliver the lab of the future vision for LP1 including integrated digital, paperless processes.
• Participate on the local area lead teams and Quality Lead Team.
• Works closely with Global Quality Laboratories and Global QC Operations to ensure consistent and standardized approaches to laboratory organizational design, business processes, and systems.
• Exhibit critical business decision bringing about successful results.
• Communicate to and strive for integration with support groups inside and outside the plant.
• Coordinate laboratory related business planning and budget management.
• Ensure safe work environment that complies with regulations.
• Serve as a conduit for corporate communications as needed.

Compliance Oversight

• Quality and compliance consistency across laboratories.
• Coordinate and manage all regulatory and internal inspections.

Personnel Development

• Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports.
• Recruit new talent and develop site capabilities to deliver a high functioning QCL organization.
• Ensure administrative and technical capability within the organization.

Basic Requirements:

• Bachelor’s degree in chemistry, microbiology, engineering, or related discipline
• Minimum of 10 years supporting complex analytical testing (chromatography, bioassay, and analytical characterization)
• 2+ years working in a GMP/cGMP environment
• 5+ years leadership experience
• Expertise in quality and compliance requirements for analytical laboratories
• Experience with regulatory submissions

Additional Skills/Preferences:

• Proficiency with computer systems including Microsoft Office products
• Demonstrated technical writing ability
• Demonstrated strong oral and written communication
• Demonstrated interpersonal skills with ability to lead leaders and influence cross-functionally and externally
• Demonstrated ability to maintain a safe work environment

Additional Information:

• Ability to travel (approximately 10%)

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$156,000 - $228,800

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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