Sr. Manager - Analytical Chemistry

Society for Conservation Biology; Indianapolis (IN); On-site; USD 91,000 - 135,000; Full time

Job summary

A leading company in healthcare is seeking an Analytical Chemistry Laboratory Manager in Indianapolis. The role involves overseeing laboratory operations, ensuring compliance with GMP practices, and leading a team to develop analytical testing methods. Candidates should have a strong background in analytical chemistry and management experience. The position offers competitive compensation and benefits.

Benefits

401(k) plan

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Flexible spending accounts

Life insurance

Employee assistance program

Qualifications

• 3-5 years of previous management experience required.
• 10+ years of related technical experience preferred.
• Familiarity with GMP Quality systems and analytical instrumentation.

Responsibilities

• Manage up to 10 staff and ensure laboratory readiness.
• Conduct document reviews and ensure compliance with regulatory requirements.
• Drive process improvements and manage stakeholder relationships.

Skills

Leadership

Analytical Chemistry

Compliance

GMP Quality systems

Education

BS in Science

Advanced scientific degree

Tools

Empower

Chromeleon

EndoScan

ApexGuard

LabX

LARA

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 serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. The Lilly RLT facility located in Indianapolis, IN, supports that purpose through the development and manufacture of Radioligand drug products for the treatment of cancer. Radioligand Therapies represent a new technology in the treatment of cancer which reduces impact to surrounding tissues and offers great promise to patients.

Lilly RLT is currently searching for an Analytical Chemistry Laboratory Manager. The Analytical Chemistry (AC) Manager ensures laboratory readiness to develop methods for analytical testing of samples/batches in a cGMP laboratory environment. Testing consists of raw materials, clinical materials, and commercial batches using a variety of analytical instrumentation and techniques while performing administrative tasks such as personnel scheduling, training, routine documentation activities, and data review.

Laboratory readiness includes all elements of the operation, including personnel staffing, equipment availability, materials availability, staff performance development, and adherence to laboratory cGMP practices/procedures.

Key Objectives

Manage for Results /Strategic Planning:

Management and Leadership Responsibilities such as:

• Ensure all activities are executed with a focus on employee safety
• Direct all group activities of up to 10 staff
• Prioritize laboratory workload, re-prioritize as needed and ensure completion of all tasks.
• Work with leadership to Identify key process indicators and metrics to ensure the laboratory operates effectively and efficiently with a focus on Right First Time.
• Evaluate, coach, and manage personnel performance. Set group objectives with management.
• Take initiative to make things better for the company, be aggressive with your work and assertive in your interactions, lead by example and build collaborative relationships.
• Build a strong, responsive team that is reliable, responsive, and flexible to shifting demands.
• Manage in alignment with the Lilly values of Integrity, Excellence, Respect for People.
• Technical responsibilities such as:
• Represent the department as a technical expert on the methods performed in the group and the results reported.
• Conduct thorough document reviews, including submissions to global health authorities.
• Respond effectively to any product or method-related trends and investigations
• Implement process improvements with senior leadership.
• Ensure that all lab operations and documentation meet all quality and regulatory requirements.
• Provide oversight and drive the reduction of analytical investigations and deviations while striving for operational excellence.
• Compose and review SOPs, protocols, reports, forms, and certificates of analysis.
• Interact with auditors and regulatory inspectors.

Compliance responsibilities such as:

• Assure adherence to acceptable cGMP practices by staff during execution of all work tasks.
• Review departmental documentation for conformance with global corporate policies and regulatory guidance.
• Represent the company through effective interactions with all regulatory officials, as needed, related to QC expertise.

ManageRelationships with Key Stakeholders and Customers:

• Drivescross functional alignment and integrationwith Process Team. LiaisonbetweentheProcessTeamand othersite functional leaders. Oversee and coordinate third-party contract laboratories to ensure support for site projects and release testing Lead lab project and/or team meetings as appropriate.

Staff Development and Management:

• Responsible for developing employees.
• Coach and mentorfor internal resources.

Resource Management:

• Fosters an inclusive workplaceand engaged workforce.
• Ensures effective hiring and staffing (right person for the right role).
• Ensure adequate materials and instrumentation to meet scheduled workload.
• Coordinate reactive and preventative maintenance with the third-party vendors.

Basic Requirements:

• BS is required. Advanced scientific degree is preferred.

Additional Preferences:

• Supervisory position with 3-5 years of previous management experience, or equivalent experience
• Proven competence with 10+ years of related technical experience.
• Experience with GMP Quality systems, including investigations OOS, OOT, LIR, Deviations, Change Management etc… as well as protocol writing and execution.
• A foundational understanding and knowledge of analytical instrumentation technologies, chromatography methods, USP compendial test methods, ICH guidelines, and good manufacturing practices.
• Availability to support the testing activities of time-sensitive radiopharmaceuticals. This may require working off-hours as needed to support the manufacturing schedule.
• Familiarity with software already in use in the laboratory (e.g., Empower, Chromeleon, EndoScan,ApexGuard, Qtegra, LabX, LARA, etc.).

Other Information:

• Minimal travel may be required (0-5%).
• Lifting not required.
• Required to be on call.
• Shift work may apply.

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

$91,500 - $134,200

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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