Scientist 2, Chemical Development & Manufacturing

Company: BIOMARIN
Location: Novato
Posted on: November 17, 2023

Job Description:

Who We Are 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. Summary:The Chemical Drug Product Device Technology (CPDT) group, which is part of the Technical Development organization, seeks an experienced scientist to manage external synthetic chemistry and manufacturing efforts, in support of pre-clinical and clinical programs. These programs span a range of modalities (traditional small molecules, peptides, and polymers with an emphasis on Oligonucleotides) produced at contract manufacturing organizations (CMOs) operating under non-cGMP or cGMP requirements, as appropriate.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 and Early Development 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 and Early Development, Global External Operations, Quality, Legal, Finance, Supply Chain and Regulatory Affairs CMC, will largely drive day to day activities. Furthermore, as part of the CPDT group, the successful applicant will strongly connect with the Drug Product Development and Analytical Sciences teams.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, optimization of chemical processes and real-time manufacturing oversight. Responsibilities:--- 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.--- Assimilate technical details (synthetic and analytical) regarding early-stage processes so as to draft effective Requests for Proposals (RFPs) to be submitted to potential CMOs.--- 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 quality 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 organizations, speculative site visits and attendance at trade shows.--- Serve as Person-in-Plant as needed for manufacturing campaigns, providing real-time manufacturing oversight on both synthetic and analytical aspects of assigned programs. Participate in cGMP compliance audits, as a technical subject matter expert.--- Develop tight working relationships with Research and Early Development and Global External Operations colleagues, developing handover strategies and ensuring periodic internal information sharing.--- Drive innovation and new technology, sharing information frequently, at CPDT and wider communication platforms. Remain up to date with academic and industrial advances, through networking, literature familiarity and conference attendance. Scope: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. Education:PhD level in Chemistry or Chemical Engineering. Post-doctoral experience would be an advantage. Bachelors, Masters level candidates will also be considered, depending on academic and industrial experience. Business, leadership training or related training credentials, would be desirable. Experience:--- 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.--- Solid understanding of routine analytical methods.--- Familiarity and/or working with ERP and Veeva 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 desirable. Working knowledge of pharmaceutical regulatory requirements, appropriate to level and solid cGMP is desirable but not required.--- Excellent written and oral communication skills; expectation to present frequently, at in house forums.--- Ability to assimilate, filter, and assemble technical information from a variety of sources to glean an understanding of assigned projects--- Must be willing to work on multiple projects Environment:A suitable BioMarin office space will be assigned. Flexibility to work from home, for some of the time, will also be accommodated. Travel: 10 - 20%. This would arise from time spent on American/ European contractor sites, BMRN facilities, such as those in Marin County and Ireland, as well as possible visits to raw material suppliers in Asia. Equipment:Standard IT equipment, such as laptop and accessories. Contacts:Internally, this person will frequently interact with Research and Early Development, Global External Operations, Quality, Legal, Finance, Supply Chain and Regulatory Affairs CMC, as well as other functions. As an active member of the CPDT group and the Technical Development organization, connections with the Drug Product Development team, Analytical Sciences and the various MSAT functions, will be frequent.He/she will also be one of the main contacts for 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. In the U.S., the salary range for this position is $ 112,000 to $ 168,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
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Keywords: BIOMARIN, Novato , Scientist 2, Chemical Development & Manufacturing, Accounting, Auditing , Novato, California