Senior Director of Drug Development & Manufacturing
Responsibilities include pharmaceutical development, CMC regulatory strategies, cross functional participation with technical operations and commercialization. Will participate in selection of candidate drug/compound leads, optimization, evaluating, CMC regulatory submissions, preclinical support with up to 20% of travel, domestic and international.
- Develops, implements comprehensive, compound-specific, development strategies, tactics to meet project needs that incorporates all elements across the drug substance, drug product, analytical, CMC work space.
- Leads the scientific, technical cross functional CMC team.
- Plans, executes, oversees drug manufacturing activities for insurance of compliance with regulatory, quality, timelines.
- Performs investigations to determine root cause, determines effective CAPAs.
- Works with the regulatory team to develop CMC regulatory strategies, including quality by design, identifies gaps, mitigates risks for all CMC programs.
- Assists with developing CMC budgets and meeting agreed spending targets.
- CMOs/CRO selection
- Responsible for product design, formulation development , manufacturing processes for all CMC programs.
- Contributes to preclinical development, clinical development of lead compounds
- Responsible for managing CMC sections for all regulatory submissions, updates
- Manage personnel
An advanced degree (Ph.D. or equivalent) in pharmaceutical sciences, pharmaceutics, chemical engineering or other relevant field
10 years of experience in pharmaceutical development with all stages, aspects of development, cGMP industrial background required.
Experience in development and manufacturing for commercial of oral solid, liquid and injectable drug product formulations. Pediatric formulation development experience is a plus.
Demonstrated working knowledge of FDA, ICH and other regulatory requirements for CMC.
Candidate must also have a solid understanding of integration and partnering Pharmaceutical development/CMC with Quality, Regulatory, Operations, Non-Clinical, Clinical, and other functional areas.
Experience preparing relevant modules for regulatory submissions to the FDA is required.
Experience with regulatory submissions for international agencies is a plus.
- Proven leadership ability to align, motivate. empower team members
- Experienced with budget planning, management, establishing product development strategies, managing scientific staff from a budgetary and personnel decisions standpoint
- Demonstrated ability for critical thinking and innovation
- Ability to develop cost-effective development plans and strong sense of value for investment
- Effective communication, collaboration and negotiation
- Ability to engage and align other stakeholders outside the project team
- Ability to understand and communicate risks as well as developing and executing contingency plans for development programs
With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
Apply on company website