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Senior Manager, Parenteral Operations (Nights)

$99k - $145.2k

BioSpace

Company Overview 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, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for people who are determined to make life better for people around the world. Position Overview Lilly is investing over $2 billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina. The campus will house warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need. The Senior Manager, Parenteral Operations (Nights) will support staffing, training, and leadership of the parenteral group during asset delivery, process development, operations readiness, start‑up, and validation of the parenteral (PAR) areas, which include formulation, aseptic filling, and visual inspection areas. The role is the primary leadership point of contact for the parenteral area during the night and may require domestic travel with opportunities for international travel to collaborate with existing Lilly sites. Once the facility is turned over to operations, the Senior Manager will support meeting annual production goals and lead by example to provide coaching in safety, quality, operational excellence, compliance, and continuous improvement. Direct line supervision includes supervisors, with dotted‑line oversight of other parenteral supervisors. As a site leader and expert, you will have significant opportunities for growth into future leadership and technical roles. Responsibilities During the project phase, the Senior Manager, Parenteral Operations (Nights) is responsible for supporting staffing, training, and leadership of the parenteral group during asset delivery, process development, operations readiness, start‑up, and validation of the parenteral (PAR) areas. The position serves as the primary leadership point of contact for the parenteral area during the night. Once the facility is turned over to operations, the Senior Manager supports meeting annual production goals. The Senior Manager leads by example and provides coaching to others in safety, quality, operational excellence, compliance, and continuous improvement. Direct line supervision includes supervisors, with dotted‑line oversight of other parenteral supervisors. Key Objectives / Deliverables Integrity Leading by example with a safety‑first, quality‑always mindset. Comfortable encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product‑impacting situation. Lead/conduct area deviation and corrective action discussions with a cross‑functional team from Engineering, Maintenance, Technical Services – Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups. Present operations investigations and procedures to Regulatory Agencies and act as a subject‑matter expert for related inspections, tours, and discussions. Excellence Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and practice vs. procedure evaluations. Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve. Participate in the development and implementation of strategies focused on continuous improvement, root cause analysis (RCA), failure mode effect analysis (FMEA), and operational standards for supply chain excellence (OSSCE). Understand and influence the manufacturing control strategy for the area. Respect for People Support site leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes, and controls for the Parenteral manufacturing area. Be responsible for a workforce of approximately 5–20 individuals; provide leadership and develop objectives to deliver business plan goals related to production volumes, finances, safety, quality, stewardship, and people. Act as a secondary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering, and Environmental/Safety. Requirements (Education, Experience, Training) Education, Experience, and Capabilities Bachelor’s degree in a STEM or pharmaceutical‑related field of study. At least 2 years working in the pharmaceutical industry. Previous management or leadership experience, including leading or working effectively with a cross‑functional group. Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA. Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly does not provide support for or sponsor work authorization or visas for this role, including but not limited to F‑1 CPT, F‑1 OPT, F‑1 STEM OPT, J‑1, H‑1B, TN, O‑1, E‑3, H‑1B1, or L‑1. Time Commitments, Environment, and Work Authorization Ability to wear safety equipment (glasses, shoes, gloves, etc.). Ability to work 40 hours per week with overtime and flexibility to work off‑shift as required to meet key objectives. Position will involve frequent business trips domestically with potential international travel to support testing of equipment at vendor sites, visit Lilly sites to learn and collaborate, and build a global network. Travel domestically and internationally, up to approximately 20% of the year. Excellence in interpersonal, electronic, written, and oral communication. Strong technical aptitude and ability to train and mentor others. Preferred Attributes But Not Required Experience with, completion of, or understanding of: 3+ years in manufacturing/operations with 2+ years in a supervisory role. cGMP standards and FDA (or other industry) guidelines for production. Aseptic filling, single‑use assemblies, and isolator technology. Automated, semi‑automated, and/or manual inspection. Highly automated equipment (inspection, packaging, filling, assembly, etc.). Creation of standard operating procedures, work instructions, and training documentation. Equipment & facility design documentation reviews. Facility, equipment, or system start‑up. Qualification and process validation experience. Manufacturing execution systems and electronic batch release. Automated storage and retrieval system (ASRS) warehouses or AGVs. Continuous improvement methodologies and mindset – lean, six sigma, etc. Documentation, deviation, and change management systems (e.g., Trackwise, Veeva, QualityDocs, Kneat). 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 ( 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) provide strong support networks for their members and are open to all employees. Current groups include South Asian Employee Resource Group, 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 $99,000 – $145,200. 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, 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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