- This role will work collaboratively within Tech Ops and internal project teams including Drug Product, Supply Chain, Quality Control, Quality Management, CMC-Regulatory Affairs, Finance colleagues as required to necessary for timeline execution of project plans.
- As needed, work collaboratively with our Alliance Partners on product related quality or technical issues.
- Provide technical and process knowledge to lead process optimization, manufacturing/facilities investigations, the implementation of CAPAs, change management, and other quality related activities.
- Lead, co-ordinate and review activities related to OOS, deviations, change control, and CAPA's.
- Manage documentation for process validation and commercial manufacturing under cGMP guidelines and author regulatory filings (NDA, MAA and related supplementary filings).
- Collect, analyze, and summarize data for continuous process verification (CPV) and develop remediation plans for identified gaps.
- Review and approve technical reports/regulatory documents (INDs, IMPDs, and NDA/MAAs) for global submissions.
- Be a key team member of commercial drug product Technology Transfers and interface with contract manufacturers to optimize commercial manufacturing processes.
- Interface with Quality Management, Regulatory-CMC Corporate Compliance, and consultants for ensuring compliance in the manufacture of drug product under current GMP standards.
- Create and review technical documents, reports, updates and presentations for cross-functional teams and management.
- Participate in planning sessions and cross-functional team meetings.
- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry or closely related field from an accredited college or university, with minimum 8 years of experience in cGMP manufacturing environment in pharmaceutical industry either in a research and development, process development, manufacturing, or contract manufacturing role; (pharmaceutical industry); or equivalent education and experience
- Solid background in drug product and process development, technology transfer of manufacturing processes, troubleshooting and process improvements.
- Significant experience working with and managing drug product contract manufacturers including those in the US, Europe, and Asia is required.
- Experience working in a multi-cultural, multi-lingual environment is necessary with a demonstrated ability to contribute successfully to a multi-disciplinary team environment.
- Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals.
- Experience in statistical analysis, interpretation, and summarizing (control charts) of trending data preferred.
- Extensive knowledge of cGMP guidelines (US and EU).
- Attention to detail and familiarity with batch record review process and FDA quality standards.
- Hands on experience with quality systems in a regulated environment, including change control, CAPA and investigations. Working knowledge and experience with SOPs and ICH guidelines.
- Recent experience in preparation of CMC sections of US or EU regulatory filing is desirable.
- Strong project management experience with cross-functional team leadership and participation skills.
- Experience in Six Sigma with certification is a plus.
- Minimum five (5) years of experience managing CMO's desired.
- Self-motivated, organized, and be reliable and responsive as needed to perform responsibilities.
- Demonstrated alignment with Esperion's Vision, Mission, Values and Culture.
- Ability to deliver highly effective presentations which demonstrate technical expertise and are audience specific.
- Proficient with MS Office and laboratory systems.
- Excellent written and verbal English communication skills.
- Domestic and international travel required (up to 25 %).
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Associate Director, Drug Product Technical Services - Ann Arbor, United States - Esperion - The Lipid Management Company
Description
Company OverviewOur Mission:
At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.
Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI.The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.
Position Title:
Associate Director, Drug Product Technical Services
The Associate Director, Drug Product Technical Services is responsible for leading drug product development, technology transfer and manufacturing technical support activities at contract manufacturing organizations (CMOs).
A key component of the role is supporting ongoing commercial supply activities at the existing commercial sites as well as additional supply-chain expansion efforts.
This role also leads investigations into manufacturing related deviations, implementation of CAPAs, change management, and process monitoring, as well as lifecycle management of Esperion's lead drug products in commercial manufacturing.
This is a remote, work from home position with approximately 25% travel. This position will report to the Executive Director, Drug Product Development.Preferred Location:
Remote - US
Essential Duties and Responsibilities** Lead and support activities for commercial manufacturing of Nexletol and Nexlizet drug products at CMOs.
This includes but not limited to review and approval of drug product batch records, provide on-site "person-in-plant" technical oversight, and supervision of other manufacturing activities at CMOs as required.
Qualifications (Education & Experience)
Knowledge of applicable business systems including:
Trackwise, Veeva, etc.
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Associate Director, Drug Product Technical Services professionals in Ann Arbor
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Allison Mi
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