Job Description
We are excited to announce a new opportunity for a dynamic and experienced professional to join our team as theDirector of Operations - ATSat our Animal Health Manufacturing site in Elkhorn, NE. The Director will bring expertise in Quality testing and method development and be responsible for analytical robustness, improvement and innovation portfolio as a member of the Global Analytical Technical Solutions (ATS) leadership team. The Director will own management, planning and budget responsibility for the ATS analytical robustness & improvement team across Global Animal Health Manufacturing (GAHM) sites covering both large and small molecule lines of business. This pivotal role is ideal for a candidate with a strong background inQuality TestingandMethod Development, who is eager to contribute to our mission of delivering innovative and efficient analytical solutions.
Key Responsibilities:
- Collaborate with Quality Excellence and ATS colleagues to ensure execution of the RFT local portfolio.
- Engage with local QC and pharma & bio process technology teams to foster alignment, prioritize efforts, and enhance focus on our analytical capabilities.
- Support global programs within GAHM, taking ownership of critical projects that drive robustness, innovation and operational efficiency.
- Represent ATS on multidisciplinary teams, providing activity updates and insights during regional and global meetings.
- Partner with the Executive Director of ATS to strategically allocate resources across our initiatives.
- Develop and present key performance metrics for the analytical robustness and improvement team.
- Lead the rollout of successful proof of concept projects across our network, ensuring best practices are shared and implemented.
- Align Quality Control Method Remediation and Improvement initiatives with broader Product Robustness efforts, driving comprehensive quality enhancements.
- Prioritize remediation and investigation efforts in conjunction with local Site Management, Quality Operations, and Regional Heads.
Qualifications, Skills & Experience:
- Bachelor's degree in Pharmaceutical, Biopharmaceutical, Biological, Analytical Science, or Food Chemistry (Master's degree preferred).
- At least10 years of experience in Quality Control testingand extensive knowledge of thequality testinglandscape for pharmaceutical and biological products.
- Sound knowledge in key analytical technologies in large and small molecule testing
- Proven expertise inmethod development and validation, along with a strong understanding of method robustness.
- Proficiency in analytical troubleshooting, employing Design of Experiments (DoE) and scientific problem-solving techniques.
- Excellent technical writing skills and proficiency in current computer applications (Word, Excel, PowerPoint, etc.).
- A holistic understanding of pharmaceutical business processes, demonstrating strategic and critical thinking.
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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
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Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
12/5/2024*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R322919