Scientist, Chemical Development and Manufacturing -
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.
State the overall function or purpose of the job.
Functioning in the Chemical, Formulation & Device Development (CFDD) group, which is part of the Technical Development organization, the role provides day-to-day oversight and tactical management for synthetic molecule, drug substance contract manufacturing activities, especially during clinical development. As such, handovers from the Research organization and ultimately, transfer to Global External Operations, will be central.
Project management, implementation and tracking of Electronic Business Systems, cGMP document management and tracking, coordination with contractors and interfacing internal functions, including Research, Global External Operations, Quality, Legal, Finance, Supply Chain and Regulatory Affairs, will largely drive day to day activities. Furthermore, as part of the CFDD group, the successful applicant will strongly connect with Formulation and Analytical Sciences.
The position will also serve person-in-the-plant responsibilities, for both critical and routine production activities and will involve interaction with contractor technical staff, for the development and optimization of chemical processes.
· Through cross functional team engagement, establish and monitor program and project timelines, maintaining tight coordination with interfacing functions, to ensure continued, on time supply of drug substance, through alignment with clinical development milestones.
· Help identify process improvements, coordinate transfer and implementation of those changes and monitor ongoing improvements at the contractor sites, to ensure consolidation.
· Communicate and coordinate internal evaluation of process changes, change requests, deviations, and OOS findings. Coordinate with BMRN and contractor QA groups to ensure timely evaluation and approval of master and executed batch records, as well as other cGMP documents. Create justifications for changes, which would typically be driven by cost-of-goods, product quality, streamlined procedures and/or logistical simplicity.
· Coordinate with contractor and BMRN quality and regulatory personnel to support regulatory submissions, to implement new procedures.
· Manage technology transfer activities to and between contractor sites, encompassing process, analytical and logistical aspects.
· Acquire and share knowledge of the contract manufacturing landscape, through interaction with candidate organisations, speculative site visits and attendance at trade shows.
· Person in plant participation, to provide technical assistance, as well as representing BioMarin interests, on contractor sites. Participate in cGMP compliance audits, as a technical subject matter expert.
· Periodic in person visits to other BioMarin locations, to ensure continued connectivity and alignment, across the internal network.
· Develop tight working relationships with Research and Global External Operations colleagues, developing handover strategies and ensuring periodic internal information sharing.
· Drive innovation and new technology, sharing information frequently, at CFDD and wider communication platforms. Remain up to date with academic and industrial advances, through networking, literature familiarity and conference attendance.
This position touches on the full range of BioMarin’s synthetic molecule activities, including (but not limited to): production of drug substances under cGMP conditions; production of non-GMP regulatory starting materials; evaluation of chemistry for process and research improvements; identification and evaluation of chemical suppliers. The primary focus of the role covers both tactical and strategic aspects of clinical contract manufacturing.
Bachelors, Masters or PhD level in Chemistry or Chemical Engineering. Post-doctoral experience would be an advantage, while business, leadership training or related training credentials, would be desirable.
· A minimum of 4 years of related experience is required in synthetic molecule, drug substance operations, in either manufacturing or R&D environments. Experience in Antisense Oligonucleotide (ASO) development and/or manufacture, would be an advantage.
· Familiarity and/or working with ERP and Trackwise documentation systems are desirable, but not required.
· Working knowledge of process engineering and/or organic chemistry, at both the research level and in large-scale GMP production, is highly desirable. Working knowledge of pharmaceutical regulatory requirements, appropriate to level and solid cGMP skills required.
· Excellent written and oral communication skills; expectation to present frequently, at in house forums.
· Must be willing to work on multiple projects
Depending on the location of the candidate, a suitable BioMarin office space will be assigned. Flexibility to work from home, for some of the time, will also be accommodated.
Travel: 20% - 30%. This would arise from time spent on European contractor sites, BMRN facilities, such as those in Marin County and Ireland, as well as possible visits to raw material suppliers in Asia.
Internally, this person will frequently interact with Research, Global External Operations, Quality, Legal, Finance, Supply Chain and Regulatory Affairs, as well as other functions. As an active member of the CFDD group and the Technical Development organization, connections with the formulation team, analytical sciences and the various MSAT functions, will be frequent.
He/she will also be one of the main contacts for all clinical synthetic molecule CMO (Contract Manufacturing Organizations) work and contracts.
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.