Mgr/Sr Mgr CMC Program Management
Regeneron offers a unique, world-class opportunity for interested candidates. Regeneron has been consistently ranked a “Top Employer” in Science Magazine's rankings for pharmaceutical and biotechnology companies. Regeneron is fully committed to bringing its award-winning approach to Regeneron Ireland, its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.
Summary: The Manager/Senior Manager uses extensive program management knowledge within the drug development industry to lead programs of advanced complexity and large scope, such as late stage clinical development or commercial. The Manager/Senior Manager may also have responsibility for managing a group of CMC Team Leads and in this case be expected to apply expertise within the drug development industry to guide team members to plan, coordinate and lead the progress of assigned CMC Programs.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Functions as a liaison or lead between Global CMC Project Management and production functional areas in order to facilitate the advancement of Drug Substance Manufacturing Projects. Provides support to the Global CMC PM team and supervisor in assessing resource needs to achieve project timelines and quality milestones.
• Serve as liaison between the RAH-IOPS site, the RAH CMC site licensure team and all Global CMC project team members.
• Coordinate the CMC regulatory activities required for submission of license applications and other regulatory documents to government agencies in clear alignment with the Global CMC Project Plan.
• Ensures effective, accurate and timely communication across functional areas and partners within the CMC Project/Program, serving as a primary point of contact among Raheen functional areas for CMC Project-related issues. Communication responsibilities include but not limited to CMC Project mtg, Global CMC meetings, Manage Supply, and weekly/monthly project updates.
• Facilitates leadership in a matrix style organization with shared resources; provides expert guidance and mentorship to others through influence rather than direct authority and Has the ability to gain acceptance of others in sensitive situations and exert influence on the department and the business.
• Accountable for technical performance and results of a team; proactively and respectfully identifies and resolves individual and team performance issues; utilizes expert conflict resolution skills.
• Initiates and leads the decision-making and risk mitigation process
• Leads the development of tools and mechanisms for monitoring progress and drives effective out of the box problem solving with cross-functional teams and area managers.
• Drives sharing of information/experiences (Lessons Learned) across communities of practice, business units and networks on innovative approaches in knowledge sharing supporting the global Knowledge Management initative..
Education and Experience:
• Bachelors, Masters or Doctorate in any physical or Biological Science. 12+ years (with BA/BS),10+ years (with MA/MS or Ph.D) of relevant industry experience
• 6+ years progressive CMC Project Management experience.
• PMP certification or MBA a plus.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron Ireland is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law.
Requisition Number: 13389BR