Associate Director, Technical Services
Esperion is a purpose driven company with a singular focus on lipid management for everyone. Our innovative team of lipid management experts is committed to leveraging its understanding of cholesterol biosynthesis to develop innovative therapies for the treatment of patients with elevated low-density lipoprotein (LDL-C). At Esperion we are passionately committed to bringing complementary therapies to the hypercholesterolemia space that address unmet patient needs in a way that is “patient-friendly, physician-friendly and payer-friendly.”
Esperion’s corporate headquarters are 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, Technical Services
The Associate Director, Technical Services, is responsible for the planning and manufacturing technical support of Esperion’s active drug substances including bempedoic acid, ezetimibe, their intermediates, and regulatory starting materials. Position is remote.
Preferred Location: Remote – US
Essential Duties and Responsibilities*
- Manage day-to-day activities of API development and manufacturing at CMOs. Activities include: planning and scheduling manufacturing trials, chemical process development and optimization, review and approval of API batch records and specifications, and monitoring of manufacturing.
- Support technology transfers of API’s from one supplier to new suppliers on a global basis.
- Provide technical support to CMO’s for process improvements, new chemical syntheses, and batch investigations and deviations.
- Author technical reports and API sections of regulatory documents such as IND’s, IMPD’s, and NDA/MAA’s for global submissions.
- Evaluate and identify gaps in current and former programs, develop remediation plans or additional studies that may be required.
- Lead internal project teams and interface with CMO project teams for timely execution of the plans.
- Interact with consultants to optimize chemistry processes and manufacturing strategies.
- Collaborate with legal, QA, and regulatory, including corresponding consultants, for ensuring compliance in the manufacturing of API under current GMP standards.
- Engage with cross-functional groups including API Development, Supply Chain, Quality Management, and Regulatory Affairs.
- Prepare product development updates and presentations as required.
- Participate in the preparation of Technical Service department budget.
- Travel, when necessary, to 3rd party manufacturing and/or testing sites. [post-COVID pandemic, estimated travel 20 - 30 %]
*additional duties and responsibilities not listed here may be required
Qualifications (Education & Experience)
- MS/PhD in Organic Chemistry or Chemical Engineering from accredited college or university.
- Minimum 12 years of experience in pharmaceutical industry either in a process development, manufacturing or contract manufacturing role.
- Strong background in chemical process development, process improvements and technology transfers.
- Prior experience with the preparation of technical chemistry documents for regulatory submissions is required.
- Experience with the management of CMOs.
- Excellent written and verbal English Communication skills.
- Demonstrated ability to contribute successfully in a multi-disciplinary team environment.
- Must have hands on experience in managing diverse project activities with pharmaceutical drug substance manufacturing facilities at different geographical locations.
- Proven strong project management experience with cross-functional team leadership and participation skills.
- Requires expert, demonstrated understandings of API manufacturing and technology transfers following cGMPs, FDA, EU and ICH guidelines; as well as CMC content of regulatory submissions.
- Working knowledge of FDA, MHRA, ICH guidelines, etc.
- Strong knowledge of pharmaceutical cGMPs (US and EU). Recent experience in preparation of CMC sections of US or EU regulatory filing is desirable.
- Ability to deliver highly effective presentations which demonstrate technical expertise and are audience specific.
- Proficient with MS Office and laboratory systems. Knowledge of applicable business systems including: Trackwise, Veeva, etc.
- Demonstrated alignment with Esperion’s values and culture.
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