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Sr. Manager - Engineering

$99k - $145.2k

Initial Therapeutics, Inc.

Responsibilities The Senior Manager of Engineering is responsible for supporting asset delivery, process development, commissioning, qualification, validation, and startup of the Parenteral/DAP area as well as other engineering systems. The Senior Manager of Parenteral/DAP Engineering will be responsible for supporting the day‑to‑day engineering activities as well as planning for the 1-3 month horizon. Key Objectives/Deliverables Build a diverse and capable engineering organization based in engineering first principles. Deliver the parenteral/DAP scope and supporting systems through user requirements, design, build, commissioning, qualification, validation, and subsequent operation. Provide leadership and develop objectives to deliver Business Plan Goals as it relates to safety, quality, and equipment/process effectiveness and efficiency. Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA). Understand and influence the manufacturing control strategy for their area. Represent their staff on the Process Team. Responsible for a professional staff of approximately 5‑10 individuals supporting process engineering and/or automation. Basic Qualifications Bachelor's degree in Engineering At least 5 years of engineering experience Pharmaceutical Experience Additional Skills/Preferences 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 OSHA. Previous experience with highly automated equipment. Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment. Previous facility or area start up experience. Previous equipment qualification and process validation experience. Previous experience with Manufacturing Execution Systems and electronic batch release. Previous experience with deviation and change management systems including Trackwise. Additional Information Required to be on call, as applicable. Must be able to stand and work on the production floor for extended durations and lift materials weighing up to 50 lbs. Travel: Domestic and International travel may be required, up to 25% during commissioning of new projects. Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will 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. Compensation $99,000 - $145,200 Benefits 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. EEO and Accommodation Information 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. #J-18808-Ljbffr Initial Therapeutics, Inc.

Vacancy posted 4 days ago
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