Scientist 1, MSAT Frontline Fill/Finish

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Job description

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.

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

The selected candidate will support commercial and late-stage clinical drug product manufacturing activities for AAV gene therapy products. The candidate will also evaluate improvements to commercial fill processes/equipment and closure systems. He/she will also define appropriate studies regarding process investigations as required to support manufacturing activities and regulatory filings, and evaluate process performance for both bulk drug substance and drug product. In addition, the candidate will establish and develop laboratory capabilities in order to support previously mentioned responsibilities. To accomplish these functions, the selected candidate should preferably possess the skills to utilize a diverse array of analytical instruments to characterize peptide and protein molecules, including stability studies. The scientist will interface with the Formulation process development group, Biophysical Characterization group, Analytical Development, Quality Control, Manufacturing, Project Management, Pharmacokinetics and Toxicology to collaboratively move compounds through product development.

The ideal candidate is a self-starter familiar with the literature and keeps up with new developments in the field and is thus able to identify opportunities for continuous improvement.

RESPONSIBILITIES

Employ advanced skills in the design and data analyses of experimental studies

Able to integrate experimental design expertise with technical knowledge

Expeditiously executes experimental work to meet project goals and timelines

Utilize a diverse array of analytical instruments to characterize protein or gene therapy products

Conduct physicochemical and biophysical characterization of late-stage clinical and commercial drug products.

Disseminate research and development work in writing or oral presentation as needed

Maintain good documentation and assist in the preparation of presentations, patents, IND, BLA and NDA documentation.

Expect to adhere to Good Scientific Practices, and SOPs

Develop the technical skills of junior staff.

Ability to apply technical knowledge of biopharmaceutical processes (cell culture, purification, etc.) and engineering experience to resolve process issues.

Support manufacturing process optimization and improvement.

Skill with performance monitoring tools and their application and interpretation.

Assist in the incorporation of new technologies, practices and standards into procedures

Capable of writing and reviewing process and workflow documents, including investigations, campaign technical reviews, APRs.

Understanding of cGMPs as related to Clinical and Commercial Operations.

Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)

Perform other related activities as assigned

EDUCATION

Ph.D., in the Pharmaceutical Sciences, Biochemistry, Biophysical Chemistry or related discipline

2-5 years of post- doctoral experience in a pharmaceutical R&D environment or in a University for Scientist II position or 5-8 years for Sr. Scientist I position.

M.S. in the Pharmaceutical Sciences, Chemistry or Chemical Engineering with 8+ years (Scientist II) or 11+ years (Sr. Scientist I)

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.