Senior Manager/ Associate Director – Drug Product NPI
Senior Manager/Associate Director- Drug Product NPI
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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 coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Senior Manager/Associate Director- Drug Product NPI reports to the head of Drug Product Manufacturing and will be part of the DP leadership team.
The Senior Manager/Associate Director- Drug Product NPI will be an integral member of the Shanbally Drug Product Team. He/She will be responsible for the leadership and delivery of new product introductions to the new Drug Product facility on site.
The scope of this role will cover from technical transfer kick off through to PPQ completion, regulatory submission, inspection readiness and regulatory approval in key markets. Another key element of this role will be to deliver expert technical product oversight and support for all planned operations on an ongoing basis.
The successful candidate will lead all technical transfer activities and manage associated product lifecycle documentation as products are introduced into the facility. As part of this technical oversight role they will ensure practices developed within site operations comply with the appropriate BioMarin standards and current regulatory guidelines by creating strong linkages for the site to both Global Sterile MSAT and Global Regulatory Affairs CMC.
This role will also have responsibility to ensure that the inspection readiness program for the new facility is robust and fit for purpose providing maximum assurance of successful inspection outcomes as the facility comes on stream to support global market supply.
The role will interact with all key departments on site and will be designed to be cross-functional in nature. One goal of the Senior Manager/Associate Director- Drug Product NPI will be to elevate the technical learning and development of the wider cross-functional team through playing a technical mentoring role on site as these new technology/processes are brought on-line. The successful candidate will be responsible for assessing and implementing technical solutions for planned products and modalities leveraging available and emerging technologies. It is the Senior Manager/Associate Director- Drug Product NPI responsibility to support technical operations and coordinate the inspection readiness programme.
Main areas of responsibility:
- New Product Introduction for SBY Drug Product Operations.
- Responsible for tech transfer of new products into manufacturing in adherence with tech transfer quality and regulatory requirements
- Key team member to oversee new product introductions at the SBY site, from development batches to approval and commercialisation.
- Ensure process alignment between sending site and SBY site via the Global Sterile MSAT group.
- Alignment and collaboration with all stakeholders including Operations, Engineering, Quality, Global Sterile MSAT, Regulatory, Clinical, and CMC to deliver on schedule commitments
- Develop technical subject matter expertise in the broader drug product manufacturing operations team.
- Ensure Manufacturing is conducted according to GMP standards and competent authority requirements by implementing best practices in line with established BioMarin global standards
- Participates in key strategic planning activities as a key member of the Drug Product leadership team.
- Work with Global Sterile MSAT group to assess new technologies or modalities which will add value to Shanbally Drug Product Operations
- Represent Shanbally DP Operations on Strategic Network analysis efforts
- Grow the technical talent within the DP team and supporting functions.
- Lead the inspection readiness for the Drug Product program
- Provide guidance on compliance and regulations and build competency within the manufacturing team.
- Develop and maintain an internal compliance programme within Manufacturing.
- Lead in the implementation of compliance elements of manufacturing goals.
- Lead preparation for regulatory and corporate audits;
- Anticipate questions and focus areas related to ICH and Annex 1 guidelines.
- Interrogate systems and processes to confirm areas of strength and identify potential issues and planning responses
- Foster high expectations and unrelenting persistence towards continued audit success
- Generate responses to audit findings
- A relevant third level qualification in science, engineering or related disciplines.
- Masters or higher degree preferred.
- A minimum of 15 years’ experience in the bio-pharmaceutical industry with strong technical, management and/or supplier relationship management experience.
- Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process for aseptic/sterile drug product fill operations including visual inspection.
- Demonstrated ability in leading/managing technology transfer and/or product development.
- Extensive sterile filling experience is an essential requirement.
- Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long-term goals.
- Working knowledge of GMP/GDP regulations.
- Use of Lean Six Sigma tools in continuous improvement projects.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired.
- Familiarity with Trackwise documentation systems are desirable.
- Excellent project management, organizational, written and verbal communication & negotiation skills.
- A high level of initiative, influencing, coaching and questioning skills are key role requirements, as well as excellent organisational skills.
Reporting to the Head of Drug Product Manufacturing and be part of the DP leadership team.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by the law.