Director, CMC, Pharmaceutical Development
Glaukos is an ophthalmic medical technology company focused onthe development and commercialization of breakthrough products and proceduresdesigned to transform the treatment of glaucoma, one of the world's leadingcauses of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, orMIGS, to revolutionize the traditional glaucoma treatment and managementparadigm. We launched the iStent, our first MIGS device, in the United Statesin July 2012 and we are leveraging our platform technology to build acomprehensive and proprietary portfolio of micro-scale injectable therapiesdesigned to address the complete range of glaucoma disease states andprogression. We believe the iStent is the smallest medical device ever approvedby the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mmwide.
The Director, Chemistry, Manufacturing and Controls (CMC)/Pharmaceutical Development provides scientific direction and support for all pharmaceutical combination device development activities, both internal and outsourced, to support Glaukos’ combination product pipeline.
This individual will report to the head R&D for Pharmaceutical Combination Products and lead CMC internal teams and directly oversee the pharmaceutical development activities and analytical test method development functional areas within Glaukos’ R&D group for combination products including CMC development and scale up to support clinical trials (Phase 2/3), registration studies and marketed product support.
· Design scientific approaches and use best industry practices in process characterization, scale-up, and technology transfer for drug/device combination products.
· Possess a broad technical experience/expertise across the following disciplines: drug delivery science, process science/scale-up, ophthalmic formulation/product development, GLP/cGMP analytical method development/testing.
· Combination product process development, sterilization and scale-up, packaging, technology transfer, in accordance with cGMPs, and ICH guidelines
· Ensure CMC writing for regulatory submissions, IND/NDA, process development reports, process validation protocol and other supporting technical documents
· Ensure CMC gap analysis and identification of critical process parameters
· Ensure establishment of appropriate specifications (API, DP, excipients and components) 12)
· Manage authors and/or the assembly of expertise specifically CMC sections of regulatory filings in consultation with CMO/CRO laboratories and/or manufacturing facilities
· Provide strong technical leadership and activity management with CROs and CMOs to ensure API, drug product development and testing activities are in compliance with current GMP and regulatory requirements
· Ensure all development reports are completed timely to support regulatory filings.
· Collaborates effectively with Applied Research, Manufacturing, and Quality to ensure seamless technology transfer of processes, methods and formulation in compliance with cGMP guidelines at all times.
· Promote and introduce new or improved processes to manufacture drug delivery systems to enhance internal capabilities of the Combination Device R&D team.
· Extensive interactions with the corporate team to manage, measure and assess goals and effectiveness in accordance with current Good Manufacturing Practices (cGMPs) Quality System Regulations for medical devices and pharmaceutical products (CFR 21 Part 4, 820.20, 820.30, 820.50, 820.100 and 210, 211) company policies and expectations
· Set and measure department goals and objectives; create and manage department and/or project budgets
· Collaborate cross-functionally to drive process development of drug products for late stage clinical studies
· Strategically manages the organization in response to project load
· Directly and indirectly manage staff for pharmaceutical development and testing including coaching, goal-setting, and performance assessment
- 12+ years in medical device and/or pharmaceutical research and development CMC or manufacturing functions.
- Experience in authoring CMC sections in IND and ex-US equivalents and responding to regulatory authorities’ comments/questions in EoP2, pre-NDA meetings.
- Demonstrated ability to manage a pharmaceutical/ combo device development staff for the scale-up of drug product from clinical supplies through commercialization, to market.
- Experience in late stage drug development and commercial manufacturing is highly desirable.
Preferred Additional Skills:
- Excellent teamwork and communication skills.
- Excellent management skills
- Expert knowledge of pharmaceutical and or combination medical device development, scale-up and technology transfer
- Ability to foster and cultivate relationships within and outside the R&D department.
- A positive, “can do” attitude and flexibility
- Experience in developing and organizing a budget
- Must be able to handle ambiguity
- Must be able to interact with and influence the most senior levels of the organization
- Transformation mindset
- Demonstrated business acumen (i.e., ability to understand and then execute against the company’s business strategy)
- Requires a PhD in Pharmaceutical Chemistry, Chemical or Biomedical Engineering, Engineering or a related pharmaceutical-biotechnology, medical device discipline.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf