Executive Director Head of CMC Leadership
Posted on
Oct 11, 2022
Profile
Who We Are: For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic diseases. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions.
Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our Culture: Our desire to make a positive impact on our patients extends to our employees, and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinate the worldwide movement of our drugs to patients.
Summary: The Head of CMC Leadership will act as the single point of contact for the entire CMC product portfolio and will be accountable for the performance of all CMC product teams. This position will report to the Executive Director, Head of CMC Integration.
Scope:
- Mentor and lead a group of 10 CMC (Team) Leads through both solid and dotted-line reporting relationships.
- Identify and address common issues affecting multiple CMC programs, from a technical, personnel, and operational perspective.
- Ensure all CMC teams are functioning in a consistent manner using existing tools and processes or developing new ones as needed.
- Be the CMC representative at the Supply Review Meeting as part of the S&OP Process.
- Cultivate and maintain strong relationships with peers in other functional organizations, including Head of Product Quality Leaders, Head of Supply Chain Owners, and Technical Development Leadership, to enable rapid and seamless cross-functional problem-solving.
- Work with the Head of CMC Operations to ensure that CMC team inputs into the portfolio planning and budget process are appropriate and timely.
- Take a leadership role in any portfolio-level activity prioritization discussions with TOPS leadership.
- Coordinate CMC portfolio plans with global company plans, internal manufacturing site production plans, contract manufacturing production plans, clinical development plans, and CMC regulatory filings.
- Focus on continuous improvement of team capabilities by ensuring that partner team leads have the opportunity for training and development to excel in their role as functional representatives and cross-functional team members.
- Actively participate and potentially own the implementation of new processes and systems crafted to improve the efficiency and effectiveness of the CMC Leadership function.
- Work in close partnership with CMC Leads and CMC Project Managers to develop and present pipeline content including regular dashboards and program and portfolio reviews to the TOPS Leadership Team.
- Directly manage one or more CMC teams in cases of extenuating circumstances (e.g. CMC product lead is on leave).
- Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals.
- Work closely with the Head of Early-Stage CMC to facilitate effective transition of early stage programs to full CMC management.
- Consider specific molecule, modality, and therapeutic area to adapt development strategies when technical development gaps are identified during the intake process.
- Maintain technical competence of all therapeutic modalities and their manufacturing and analytical schemes to facilitate productive engagement of the CMC product teams and gain trust of CMC Product leaders.
- Work with Head of CMC Technical Strategy to support application of CMC “playbook” by product teams via the use of technical maturity matrices, best practice documents, and technical stage gate reviews.
- Strong technical and regulatory understanding of the CMC concepts detailed in the documents and how they apply to different molecules will be critical for facilitation.
- Partner with Head of CMC Innovation and Technology to synthesize and articulate technical problems arising from CMC teams, such that the correct innovation targets are identified.
- Engage with WWRD and PPD organizations to address strategic, scientific, and technical issues that impede the success of the program portfolio.
- Participate in corporate governance as needed to support this objective.
Essential characteristics for this candidate:
- 10 years of experience in a technically oriented role; experience in process, analytical development, or quality control is required.
- Demonstrated success in CMC Product team leadership; experience in early stage and/or clinical product teams is required.
- Ph.D. in Biotech, Chemical Engineering, Biology, or Chemistry or related field is highly preferred; additional/postgraduate qualifications (MBA, PMP, PMI) are a bonus.
- Outstanding project management skills, specifically timeline and budget development and oversight with experience at all phases of the product lifecycle.
- Experience leading a portfolio of multiple products, and prioritization of activities and resources.
- Proven proficiency and hands-on experience with typical CMC activities.
- Understanding of standard technical development strategies, cGMP requirements, and quality management systems for the pharmaceutical or biotechnology industry environment.
- Applies technical and scientific expertise in project management and contributes to the development of new concepts, techniques, and standards.
- Experience managing projects with remote teams and through external alliances preferred.
- Previous people management experience required along with a passion for employee development.
- Proactive and strategic problem solver, with strong facilitation, problem-solving, and issue resolution skills.
- Highly collaborative with outstanding communication and relationship management skills, high emotional intelligence.
- Creates highly effective strategic vision and has a remarkable sense of how situations can unfold; prepares well in advance to take fullest advantage of the changing environment.
- Adept at balancing cross-functional interests in establishing operational strategies and identifying, resolving preempting operational challenges, risks, and issues.
- Influences senior management and cross-functional teams on decisions regarding the balance of quality and timeliness, taking into account activities across a project or portfolio of projects.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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