- Responsible for technical oversight of a portfolio of biologic Drug Products at external Contract Manufacturing Organizations (CMOs) and internal sites (including Cork, Shanbally and Novato, California) including process performance monitoring/optimization, continuous improvement, process robustness and LCM.
- Ensure that Drug Product manufacturing processes perform as developed and validated while ensuring continuous process improvement through the application of scientific and engineering expertise.
- Drive technical requirement for pipeline products assisting late phase and PPQ campaign activities between Technical Development group and External Manufacturing network.
- Ensure readiness of processes for commercialization. RESPONSIBILITIES
- Provide technical oversight for product (s) manufacturing/testing executed at external and internal partners.
- Act as Technical Development technical representative on process teams.
- Act as an SME on biologic Drug Product, including technology transfer, process validation, trouble shooting and investigation on specific product(s).
- Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.
- Initiate and lead product improvement projects, involving cross-functional teams.
- Establish and maintain internal / external network relationships around control strategy.
- Performs statistical data analysis to recognize trends, identify and drive process improvement or minimize product impact.
- Assist technical and project management leadership during technology transfers.
- Lead risk assessments in support of product(s) technology transfers to external partners.
- Identify and lead product and process improvement initiatives to reduce COGM (Cost of Goods Manufactured). Process Development/Optimization
- Develop data driven strategies for process development / product characterization.
- Develop designs of experiments for execution of lab studies/analytical work with a high level of autonomy. Late Phase Clinical and PPQ Campaign Activities
- Provide technical input into site selection for late phase to commercial manufacture.
- Provide technical oversight / assistance of late phase campaign at external and internal partners.
- Investigations support / leading role depending on type of investigation.
- Campaign monitoring.
- Provide on-site support (Person in Plant) to external and internal partners.
- Assist PPQ Campaign readiness and execution.
- Identify technical areas to be completed prior to PPQ.
- Raise and drive change control including justification of changes vs previous campaign.
- Maintain/update process technical document and product risk register.
- Ensure stage gate milestones requirement are met. LCM
- Identify and implement yield improvement and Value Realization projects for external and internal partners.
- Maintain oversight of process performance at external and internal partners.
- Maintain knowledge of entire manufacturing process throughout the lifecycle of product.
- Lead the development and implementation of Lifecycle Management of Product/Process knowledge.
- Develop and execute a life cycle improvement plan for product(s) in partnership with external and internal partners.
- Ensure and maintain an appropriate process control strategy based on critical quality attributes and other attributes as appropriate.
- Assess changes to input materials and drive material qualification activities from a technical standpoint. Documentation
- Author, review and approve technical reports including protocol/reports.
- Review and assess any updates or changes of the Process description documents.
- Create and maintain a process specific risk register.
- Review agency annual product reviews. Regulatory
- Author CMC sections of regulatory dossiers.
- Support regulatory inspections for process-related aspects of assigned products when necessary.
- Maintain oversight and reviews process technical changes, reviews their technical feasibility and challenges technical risk.
- Contribute to registration strategy and support registration activities. EXPERIENCE
- A minimum of 5 years' relevant experience in the biopharmaceutical industry with a strong MSAT and process development experience in Drug Product biologics.
- Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process.
- Ability to collaborate in a global team environment at all levels of the organization.
- Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long-term goals.
- Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of biologics.
- Excellent organizational, written and verbal communication and negotiation skills.
- Experience with Change Control, Deviation, CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.
- Demonstrated strong leadership and coaching qualities. EDUCATION
- Minimum B.Sc. (M.Sc. or PhD Preferred) degree in relevant scientific discipline e.g. biochemistry, microbiology, biological sciences or related biopharmaceutical science.
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Senior Scientist, Technical Development Commercial Support - Novato, United States - BioMarin
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.
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 $ 128,000 to $ 192,000 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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