Senior Scientist 2, Chemical Development & Manufacturing

b'nnnnnnnn Senior Scientist 2, Chemical Development & Manufacturing | BioMarinnnnn n n nnntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnnn nn

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n Novaton

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n BioMarin Pharmaceuticaln

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Senior Scientist 2, Chemical Development & Manufacturing

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Location: Novato, United States

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Workstyle: Hybrid

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Who We Are

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BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

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Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

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About Technical Operations

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BioMarinxe2x80x99s 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 BioMarinxe2x80x99s 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.

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Seniorxc2xa0Scientist 2, Chemical Development & Manufacturing

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This exciting role has emerged due to growth in thexc2xa0Chemical Development & Manufacturing group, which is part of the Drug Substance Technologies (DST) function in the Technical Development & Services (TDS) organisation. Our pipeline consistently features new and diverse programs, which require development and manufacturing leadership throughout the full product lifecycle.

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The Chemical Development & Manufacturing group leads the CMC development for all synthetic chemistry programs across Technical Operations (TOPS); while the diversity of modalities are continuing to grow, small molecules, oligonucleotides, peptides and PEGs are firmly established. A wonderful opportunity for a team player, with appropriate scientific skills and experience, as well as an energetic, growth mindset, to join an established, high functioning team.

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The role involves driving clinical programs, through PPQ, as axc2xa0Partner Team Lead (PTL).

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Cross functional collaboration behaviors are critical to the role, where connectivity forms a mainstay of day to day activity.xc2xa0 Interfacing groups include other Drug Substance modality functions, sister groups in TDS, including Formulation and Analytical departments.xc2xa0

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Broader interfacing groups in the widerxc2xa0TOPs organization are also in play, especially External Manufacturing, Quality and Supply Chain, as well as enterprise-wide synergies with Research, Regulatory Affairs, Finance, Legal and others.

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Project management, especially with regard to active programs withxc2xa0Contract Manufacturing and Development Organizations (CDMOs), will draw upon excellent written and communication skills, as well as strong leadership behaviors. Contribute to the group strategy, participating in budget preparation and monitoring, as well as program planning.

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Leadership Responsibility:

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Through cross functional team engagement, collaboratively working on the technical team, ultimately to meet Enterprise-wide program timelines, including:

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• Identify and assist in selection of new CDMOs, building a deep knowledge of the external landscape. n
• Together with the DS team, drive the strategy and performance of the CDMO network, as well as the internal functions, to deliver enterprise and group goals. n
• Anticipate scientific, business and program challenges, while working cross functionally to solve problems. n
• Manage drafting and delivery of 3.2.S filing sections and address HA questions, in appropriate sections. n
• Periodic in person visits to other BioMarin and CDMO locations, to ensure continued connectivity and alignment, across the internal network and Person-in-plant support, respectively. n
• Play a part at the forefront of internal synthetic chemistry innovation, to ensure new technologies are identified, evaluated and implemented, positioning TDS centrally for cutting edge initiatives and early adaptation.xc2xa0 Share learnings at appropriate platforms. n

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Must have: Minimum Requirements:

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• Bachelors, Masters or PhD level in Chemistry or Chemical Engineering.xc2xa0 Post-doctoral experience would be an advantage, while business, leadership or related training credentials, would be desirable. n
• A combined minimum of 9 years of related experience is required in synthetic molecule, drug substance development environments and CMC DS program management. n
• Working knowledge of pharmaceutical regulatory requirements, as well as solid cGMP skills. n
• Excellent written and oral communication skills; expectation to present frequently, at in- house forums. n
• Demonstrated capability at handling multiple programs and projects, at the one time. n
• Agreement to work in a hybrid fashion, spending 2 days per week, on average, at the local BioMarin site.xc2xa0 n
• Travel: 20% - 30%. n

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Nice to have:

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• Experience in Oligonucleotide development and/or manufacture, would be an advantage. n
• Familiarity and/or working with ERP and quality documentation systems are desirable but not required. n

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Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.xc2xa0

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Equal Opportunity Employer/Veterans/Disabled

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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Ireland Safety Responsibility Support the organisationxe2x80x99s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

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Recruitment Fraud Alert Notice

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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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Equal Opportunity Employer/Veterans/Disabled

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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