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Scientist I/II, Chemical Development & Manufacturing

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Jun 11, 2021

Job Details

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.

Summary

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.

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.
  • 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.
Education

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.

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.
  • 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


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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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