At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept's lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist marketed under the brand name \"Ocaliva®\" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. Ocaliva® was the first medication to be approved for PBC in over twenty years, and sales continue to grow more than four years after its initial approval in 2016.
Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone. Currently, there are no available treatments for NASH, and the REGENERATE study of OCA remains the only Phase 3 trial to have generated positive results in the disease. A second Phase 3 trial, REVERSE, is evaluating OCA in patients with compensated cirrhosis due to NASH, with results expected in 2021.
People at Intercept are passionate about patients. You'll see their photos lining our walls and hear their stories in town halls. We're equally passionate about our team and ensuring each member reaches their potential. We brave new challenges together. That's how we find better ways to get things done and break down barriers. It's also how we make it fun to work here.
At Intercept, we foster an environment that celebrates creativity, collaboration and mutual respect. We never hesitate to lean on our teammates and work together. Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. A strong commitment to diversity, equity and inclusion is engrained in both our culture and our business. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.
As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Clinical Lab Manager. This is a full-time position that will function in a matrix structure to provide technical guidance to internal and external staff. The role will support analytical activities for Intercept drug candidates from early drug development programs to commercial products. The successful candidate will monitor industry practices and regulatory standards and implement state of the art method development and validation approaches. The person who fills the role will also work to set-up and monitor testing at central laboratories.
The successful candidate must be able to perform each of the following satisfactorily:
- Manage the activities of external research laboratories or central laboratories contracted to conduct assay development or sample analysis.
- Work on multiple projects and under strict timelines.
- Provide analytical expertise for internal and external collaborators.
- Review external laboratory data, monitor assay performance and provide troubleshooting guidance.
- 3rd party laboratory sample management and reconciliation.
- Review technical documents including analytical method development reports, method validation protocols and reports and standard operating procedures in compliance with regulatory requirements.
- Participate in study team meetings to provide technical guidance and review Informed Consent Forms.
- Other duties as assigned.
- Perform all duties in keeping with Company's core values, policies, and applicable regulations.
- Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
- Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
- Make Intercept a truly desired place to work
Experience and Skills
- BS Degree (biology or chemistry preferred) with 6 years of applicable pharmaceutical/biotech experience, or Graduate Degree with 4 years of applicable pharmaceutical/biotech experience.
- GXP experience required
- Bioanalytical and/or CLIA experience a plus
- Experience in multiple therapeutic areas, with prior experience in hepatology, gastrointestinal or related field, preferred
REQUIRED KNOWLEDGE AND ABILITIES:
- Advanced applied knowledge of the following:
- FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, regulatory documents and
- Experience in quality control and/or quality assurance of regulatory submissions/aggregate reports within the pharmaceutical industry is critical
- Demonstrated analytical skills and extremely high attention to detail
- Demonstrated strength in oral/written communication and interpersonal skills; team player
- Demonstrated organizational skills
- Advanced functional experience in the following computer applications: Microsoft Word, Microsoft Excel, PowerPoint, Prism
- Strong verbal and written communications skills
- Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
- Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity
- Ability to have fun and thrive in a growing, diverse and inclusive work environment