Sr. Scientist 1

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Novato

BioMarin Pharmaceutical

Sr. Scientist 1

Location: Novato, United States

Workstyle: Hybrid

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Who We Are

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

Guided by our purpose to develop medicines that make a profound impact on peopleâ€s 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.

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.

About Technical Operations

BioMarinâ€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 BioMarinâ€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.

Formulation and Product Technologies (FPT) is comprised a team of scientists responsible for , Formulation and Drug Product development. FPT is responsible for end-to-end development of chemical/synthetic and biologics molecules in collaboration with multi-disciplinary partners. FPT team delivers stable formulations, reliable processes and technologies for drug product, combination products and administration components from early to late stage for various modalities including small molecules, oligonucleotides, peptides and proteins/enzymes. We develop platform strategies to enable fast to patient approaches, including DP development and manufacturing for outsourced programs.Â

Role Summary

BioMarin is seeking a highly motivated individual with drug product development experienceâ€"preferably in solid oral dosage formsâ€"to oversee drug product development and manufacturing activities. This role may be fulfilled as a subject matter expert (SME) in drug product formulation development or as a Drug Product Partner Team Lead.

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The Drug Product Partner Team is responsible for all aspects of drug products and finished goods development in support of CMC deliverables. The team is crossâ€'functional and includes representatives from Formulation Product Technology (FPT), Drug Substance, Analytical Development, Manufacturing, Packaging and Engineering Development, along with other key functional groups.

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The successful candidate will bring broad and deep expertise in drug product development, including but not limited to technology transfer, formulation development (small molecules, Oligos, peptides) and optimization, primary packaging design, drug product process development, fill/finish process development and optimization, primary and secondary labeling and packaging development, and shipping design and qualification.

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The individual is expected to routinely report on project activities, issues, strategies, and risks to CMC leadership and management. This role also serves as the scientific monitor for formulation development, technology transfer, and manufacturing activities conducted at CDMOs/CMOs.

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The position requires the application of scientific expertise, industry knowledge, and sound judgment to contribute to complex company objectives. In addition, the individual will contribute to the overall strategy, performance, and direction of the function. Knowledge of GMP requirements is preferred.

Role and Responsibilities

• Plans experimental strategy and formulation development across nonâ€'clinical and clinical phases for small molecules, oligos, and peptides.

• Collaborates within a matrix organization (Research, PD, QC, Drug Substance, Analytical, MSAT, Manufacturing, CDMOs/CMOs, Market Planning, Regulatory) to deliver project objectives.

• Provides scientific guidance to junior scientists on experimental design, troubleshooting, data interpretation, and technical challenges.

• Designs experiments and technical strategies to address formulation and process issues.

• Leads drug product formulation development and optimization.

• Leads the crossâ€'functional CMC Drug Product Partner Team and represents the team in CMC forums.

• Coordinates with other partner teams to develop recommendations and options for CMC decisionâ€'making.

• Interprets experimental outcomes and provides integrated recommendations to CMC teams.

• Ensures timely, clear communication between the Drug Product Partner Team, CMC team, and functional management.

• Identifies, mitigates, and escalates risks related to quality, timelines, and scope.

• Accountable for tracking and reporting milestones and deliverables to the CMC Project Manager.

• Represents the Drug Product team at Core Team meetings and is accountable for DP deliverables.

• Supports CDMO selection, due diligence, and site evaluations.

• Reviews and provides input on protocols and reports supporting formulation development, tech transfer, and manufacturing.

• Reviews technical documentation and contributes to regulatory submission content.

• Contributes to the overall strategy, performance, and direction of the Chemical, Drug Product, and Device Technologies function.

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Education Required

Ph.D. in Biochemistry; Pharmaceutics Sciences, or related fields with 5+ years of industry experience

MS or BS with extensive industry experience

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Experience Required

• Experience leading multi-disciplinary team and providing oversight of cross-functional activities within the team, to bring about the successful planning, monitoring, and executing of deliverables.
• Experience with designing parenteral formulation screening and optimization studies, experience in gene therapy drug product development is preferred.
• Hands-on experience in solid oral dosage form development, including pre-formulation and formulation of tablets, capsules, and oral solutions.
• Experience with parenteral drug product formulation development, characterization, testing, quality risk assessment and CMC regulatory guidance and filings.
• Strong leadership and team management skills. A strong team player with good collaborative and people skills.
• Strong organization and prioritization skills, ability to facilitate and drive program forward
• Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changes
• The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications.
• Experience in authoring/reviewing CMC sections for regulatory filings with health authorities.
• Excellent technical writing skills, experience authoring/reviewing development reports, batch records, regulatory filings, or other documents.

Supervisor Responsibility

May lead 1-2 associates

Competencies Required

The position requires:

• Strong leadership, negotiation, and influencing skills

• Well-developed organization skills with exact attention to details.

• Strong deductive reasoning skills

• Excellent written and verbal communication skills.

Technical expertise

• Solid understanding and familiarity with pharmaceutical characterization and testing equipment such as HPLC (RP-HPLC, SEC, ion exchange chromatography), DSC, UV spectrophotometry, particle size measurement techniques, DLS, Differential Scanning Fluorimetry (DSF), and so on.
• Operational knowledge and experience with small molecules, oligos and peptides fill finish operation and tech transfer.
• Familiarity with parenteral dosage forms, manufacturing processes, and packaging components is a plus
• Critical thinking and evaluation
• Influencing
• Organizational Awareness
• Performance Management
• Self-Knowledge

Behavioral

• Accountability

• Achieving Excellence

• Communication

• Courage / Challenge

• Develop Self & Others

• Judgement

• Reliability

• Teamwork

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Work EnvironmentÂ

Hybrid - would require 2-3 days onsite in Novato, CA

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.

Equal Opportunity Employer/Veterans/Disabled

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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The salary range for this position is: $130,400 to $179,300. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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Recruitment Fraud Alert Notice

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.

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.

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.

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

Equal Opportunity Employer/Veterans/Disabled

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.

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, email Applicant_accommodations@bmrn.com with your request.

This 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.

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 â€" please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at talentacquisition@bmrn.com.

Applicants, please do not use this email address to submit resumes â€" if you do so, you will be redirected to apply through the website.

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

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