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Technical Specialist

Company: Esperion Therapeutics Inc.
Location: Boulder
Posted on: March 27, 2020

Job Description:

Company OverviewEsperion is a small company doing big things. 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: Technical Specialist/Senior Technical Specialist, Technical ServicesThe Technical Specialist, Technical Services, is responsible for the technical support of Esperion's active drug substances including bempedoic acid, their intermediates, their regulatory starting materials, other drug substances in development.-- This position will review of SOPs, test methods and specifications for raw materials/intermediates/drug substance, validation protocols/reports and stability summaries. Provide on-site "person-in plant" technical oversight to ensure reliable product supply and product quality.-- Support contractor site investigations pertaining to OOS/OOT and deviations is expected.-- Position is in Boulder, CO or remote US.Preferred Location: Boulder, CO or Remote - USEssential Duties and Responsibilities*Provide on-site "person-in plant" technical oversight to ensure reliable product supply and product quality.Assist in the technical review of activities at various CMO's engaged in cGMP manufacture of API for Esperion.Interact with cross-functional teams in project management, analytical chemistry, QA and regulatory affairs to move projects forward and adhere to project timelines.Review manufacturing batch records and advise on document management under cGMP guidelines.Co-ordinate and review activities related to OOS, deviations, change control, and CAPA's.Provide content review of documentation for process validation and commercial manufacturing in preparation for regulatory filings (NDA, MAA, and related supplementary filings).Review source documentation for cGMP manufacturing campaigns (raw material, IPC/release testing) for regulatory filings.Participate in planning sessions and cross-functional team meetings.*additional duties and responsibilities not listed here may be requiredQualifications (Education & Experience)4 years in science education with Chemistry experience preferred or BS in Organic Chemistry or Chemical Engineering2-5 years of experience in cGMP manufacturing environment (pharmaceutical industry preferred).Senior Technology Specialist has 5 - 10 years' experience.Solid background in multi-step small molecule drug substance manufacturing processes.Extensive training in cGMP guidelines.Experience reviewing documents for projects at CMOs or worked at CMOsFamiliarity with batch record review process and FDA quality standards.Experience with quality systems in a regulated environment - working knowledge and experience with SOPs and ICH guidelines.Proficient with MS Office and laboratory systems.-- Knowledge of applicable business systems including:-- Trackwise, Veeva, etc.Office environment with domestic and international travel required (5 to 10%)Demonstrated alignment with Esperion's values and culture.Notice to Agency and Search Firm Representatives: Esperion Therapeutics is not accepting unsolicited assistance from agencies and/or search firms for any job posted on this or a referring site. Please, no phone calls or emails. All resumes submitted by an agency and/or search firm to any employee at Esperion via email, the internet, or in any other form and/or method without a valid written agreement in place will be deemed the sole property of Esperion. No fees will be paid in the event that a candidate is hired by Esperion as a result of an unsolicited agency and/or search firm referral

Keywords: Esperion Therapeutics Inc., Boulder , Technical Specialist, IT / Software / Systems , Boulder, Colorado

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