(CW) Manufacturing Associate (TEMPORARY)
Biomarin Pharmaceutical Inc. job in Novato, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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.
Temporary Manufacturing Associate position is for a 6pm to 7am shift from Wednesday to Saturday, with every other Saturday off.
Responsibilities:
Operating large-scale bioprocess equipment for Cell Culture, Purification, or Buffer and Media processing; performing all aspects of processing with a broad understanding of science, compliance, and technical aspects; displaying competency with process equipment and automated control systems; performing cleaning and sterilization of parts and equipment used in the manufacturing process; and having knowledge of biotech manufacturing processes and equipment, including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation, and/or buffer and media operations. The candidate should have the ability to understand, apply, and evaluate basic chemistry, biology, and scientific principles as appropriate for the position. Proficiency with compliance, adherence to standard operating procedures, batch records, good documentation practices, and data capturing is also essential.
Desired skills: 1-2 years of experience in a GMP and Manufacturing field. The equipment involved includes chromatography skids, TFF skids, buffer tanks, lab washers, and autoclaves.
Education: Bachelor's degree in a science-related area or engineering, or an associate's degree in a science-related area or a biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry. (While a BA/BS is preferred, it is not required; a biotech certificate is acceptable).
Work Environment: Involves strenuous, repetitive work. This includes daily physical movements such as bending, reaching, climbing stairs and ladders, kneeling, and making numerous equipment connections using hands.
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.
In the U.S, the salary range for this position is $ 15 to $ 30 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $15 to $30. 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.
For additional benefits information, visit:
Associate Director, Biostatistics (Study Lead)
Biomarin Pharmaceutical Inc. job in San Rafael, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
Biostatistics Study lead:
As a Statistical Science Study Lead, the Senior Manager is responsible for leading and managing all Statistical Science-related activities for one or more studies of a comprehensive program to ensure high-quality deliverables are executed in line with agreed timelines.
* Provide statistical leadership, as a member of cross-functional study team, during protocol development (study design, sample size justification, and safety/efficacy analysis methods) and throughout study duration
* Collaborate with key stakeholders on study design and develop statistical analysis plan
* Analyze and validate data to support study deliverables, including filings, reports, publications, and presentations.
* Provide leadership and oversight for all Data Science deliverables for the study
RESPONSIBILITIES
For an assigned study, the Statistical Science Study Lead will perform a range of the following responsibilities:
Cross-Functional Leadership
* Chair, or select a delegate to chair, Data Science functional and cross-functional program teams (Statistical Analysis and Review Team (SART) according to team charters to ensure appropriate cross-functional collaboration, communication, and expert input into program deliverables and outcomes
* Communicate Statistical Science and/or Data Science guidance as a representative or lead representative in cross-functional study teams (e.g., Study Execution Team)
Statistical Science Deliverable Development and Execution
* Lead, and collaborate with others in Data Science, in the development of the statistical analysis plan (SAP) for the study including endpoint definition, sample size justification and statistical methodology; lead the execution of statistical analysis activities as outlined in the SAP and the related quality review and approval of deliverables
* Collaborate with others in Data Science and cross-functional stakeholders on study design
* Develop, and/or contribute to the development of, the following study-related deliverables: appropriate sections of study protocols, case report forms, data quality review and analyses, manuscripts, and sections of clinical study reports
* Contribute to and negotiate study timeline with cross-functional team; identify Statistical Science study resource needs to meet timeline
* Provide statistics area expertise to study team activities and deliverables
* Serve as the statistical expert for the study throughout the study lifecycle and ensure accuracy and reliability of statistical results for the entire study
* Work with cross-functional study team members (SET), other key stakeholders, and statisticians to analyze and interpret clinical study data
* Identify and manage issues and risks and escalate, as appropriate
* Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the program
* Understand and follow Statistical Science processes for study execution for all Statistical Science-related study deliverables
* Develop SOPs, WIs, guidelines, and templates
Clinical Development Focus
* Lead or support activities to prepare for meetings with regulatory agencies, including oral/written responses to agency questions, as needed
* Provide statistical leadership for preparation of marketing applications (e.g., NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies and other regulatory submissions (such as IND safety update, PSUR)
* Ensure the quality of data and accuracy of analyses in regulatory interactions (e.g. submissions) or publications
Subject Matter Expertise
The Senior Manager will be a subject matter expert. This position will contribute to and make an impact on the department and the cross-functional process.
EDUCATION
* PhD degree preferred, or MS in statistics, biostatistics or related discipline
EXPERIENCE
* 3+ years clinical trial experience in pharmaceutical and/or biotech company with PhD; 6+ years with MS
* Must have worked on statistical analysis plans, study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, and annual reports (or periodic safety update reports), electronic NDA and/or BLA submissions via eCTD, IND, CTA, or HTA interactions
* Strong programming skills in SAS, R, and other statistical software packages
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.
The salary range for this position is: $167,500 to $251,300. 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.
For additional benefits information, visit:
Account Executive, NES -California-North (Bay Area, Sacramento)
San Francisco, CA job
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
Why Join Diasorin?
* Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
* Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!
Job Scope
The Account Executive is responsible for driving revenue growth, new account acquisition, and adoption of Diasorin's non-acute Point-of-Care (POC) portfolio across a defined territory. The role operates in a hybrid sales model, selling through distribution partners while directly engaging and influencing clinical end-users in physician office labs (POLs), urgent care, retail health, and pharmacy settings. This position requires strong diagnostic sales expertise, distributor-management capability, technical aptitude in molecular/rapid testing, and disciplined territory execution to support Diasorin's expansion in the non-acute POC market.
* Territory includes California-North (Bay Area, Sacramento). Candidate must reside in territory.*
Key Duties and Responsibilities
Territory & Account Management
* Execute a disciplined sales process including prospecting, pipeline development, account planning, and quarterly business reviews.
* Drive adoption of Diasorin's non-acute POC portfolio through product demonstrations, workflow discussions, and value-based selling.
* Achieve or exceed revenue targets, quota attainment, trial-to-conversion metrics, and territory growth objectives.
* Manage large geographies effectively while prioritizing high-value opportunities.
Distributor & Channel Partner Leadership
* Build, coach, and support national and regional distributor partners (e.g., McKesson, Cardinal, Medline, Henry Schein).
* Conduct joint sales calls, ride-alongs, distributor training, and business reviews to accelerate pull-through.
* Support distributor pipeline development, opportunity qualification, and territory execution.
* Monitor distributor KPIs and collaborate to address performance gaps or conflicts.
Customer Engagement & Clinical Insight
* Engage confidently with Lab Directors, Medical Directors, nursing leadership, office managers, and clinical teams.
* Deliver customer training, workflow optimization discussions, in-services, and onboarding support.
* Translate technical assay benefits into clinical outcomes, operational efficiency, and financial ROI.
* Maintain understanding of clinical workflows, CLIA-waived environments, and relevant quality metrics.
Technical & Molecular Aptitude
* Communicate molecular diagnostics concepts including assay performance, sensitivity/specificity, workflow advantages, and instrument differentiation.
* Support new product launches, promotional initiatives, and regional marketing activities.
Operational Excellence
* Maintain accurate CRM data, forecasting, pipeline quality, activity reporting, and expense compliance.
* Track KPIs including sales calls, demos, distributor activations, trials, conversions, and revenue per account.
* Participate in trade shows, regional events, distributor meetings, and team trainings as needed.
Education, Experience and Qualifications
* Bachelor's degree required; scientific or business-related field preferred.
* 3-7+ years of field sales experience in clinical diagnostics, point-of-care testing, molecular diagnostics, medical devices, or lab equipment.
* Proven success selling through distribution partners in non-acute settings (POLs, urgent care, outpatient clinics, PCP offices, retail health, pharmacy-based care).
* Demonstrated ability to meet or exceed quota in a technical, consultative sales environment.
* Familiarity with molecular testing platforms (PCR/NAAT) or related rapid/respiratory diagnostic modalities.
* Strong communication and presentation skills with clinical and administrative decision makers.
* Ability to simplify complex scientific concepts for clinical audiences.
* Strong organization, accountability, and territory management capability.
* Valid Drives License is required
Preferred Qualifications
* Experience launching new diagnostic or molecular platforms in competitive markets.
* Knowledge of CPT coding, reimbursement dynamics, CLIA regulations, and workflow optimization.
* Existing relationships with key distributor representatives in the region.
* Experience managing multi-state territories.
The hiring range for this position is $110,321 - $149,258 annually and incentive compensation eligible. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.
Diasorin is 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.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at ********************* or ************** to request an accommodation.
The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.
Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.
This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.
Intern, Cytometry Shared Resource Lab
Biomarin Pharmaceutical Inc. job in San Rafael, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
SUMMARY:
The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry. Over the course of 10 - 12 weeks our interns gain industry experience while working alongside our talented team on meaningful projects
BioMarin's Research & Early Development (RED) group is responsible for everything from research and discovery to post-market clinical development. Research & Early Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.
The Center of Technology (CoTe) within RED is composed of centralized laboratories that provide expert advice, service, training and open access to state-of-the-art flow cytometry, lab automation, sequencing and mass spectrometry technologies, as well as the procurement of rare biospecimens.We aspire to accelerate early research programs, generate breakthrough data, influence the course of clinical development, and enable scientific creativity across all of RED.
JOB DESCRIPTION/PROJECT:
The position will involve working with the Lead Scientist and Research Associates in the Cytometry Core within the Center of Technology.
Skills the Intern, Cytometry Core will gain:
* Knowledge of how flow cytometry, high content imaging and cell sorting are used in a biotechnology environment to support research, bioanalysis, and clinical work
* Knowledge in how to operate a flow cytometer, high content imager and cell sorter
* Training in a typical flow cytometry assay including complex options for data analysis
* Experience in a Shared Resource Laboratory (SRL or Core Lab) touching many parts of the drug discovery process
Position is designed to function onsite only; lab time will be required 5 days a week.
Required Coursework:
* Molecular Biology and Molecular Biology Laboratory or equivalent courses
* Cell Biology or Molecular Immunology or equivalent courses
* Cell Biology Laboratory or Molecular Immunology Laboratory or equivalent courses
Desired Skills:
* Experience with common biochemistry and molecular biology techniques
* Experience with sterile cell culture techniques
* Comfort working and communicating in a dynamic, multi-disciplinary, collaborative research environment
* Excellent organizational skills and demonstrated ability to accurately complete detailed work
Qualifications/Eligibility:
* Undergraduate or Masters Candidate pursuing a degree in biochemistry, cell biology or equivalent, with an interest in a laboratory career preferred
* Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program.
* Must be available to work full-time, 40 hours a week.
* Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles.
Benefits of a BioMarin Internship:
* Apply skills and knowledge learned in the classroom to on-the-job experiences
* Comprehensive, value-added project(s)
* Work in teams and with colleagues in a professional environment.
* Develop skills specific to your major.
* Opportunities for professional development by building relationships and learning about other parts of the business.
* Participate in company all hands meetings, monthly community lunches
* Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
* Access to Employee Resource Groups
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.
In the U.S., the salary range for this position is $24 to $32 per hour, 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.
Intern, Skeletal Cell Biology
Biomarin Pharmaceutical job in San Rafael, CA
Description Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. SUMMARY:The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry. Over the course of 10 - 12 weeks our interns gain industry experience while working alongside our talented team on meaningful projects. The Skeletal Cell Biology Group at BioMarin is dedicated to advancing the understanding and treatment of genetic diseases. Our team focuses on researching the cellular mechanisms underlying these conditions and developing potential therapeutic strategies. We utilize advanced techniques and collaborate across various disciplines to drive innovation in research. JOB DESCRIPTION/PROJECT:As an intern in the Skeletal Cell Biology Group, you will have the opportunity to work collaboratively on several research projects within BioMarin's pipeline. Your responsibilities will include conducting cell culture experiments involving the maintenance and characterization of mammalian cell lines, supporting molecular biology techniques such as PCR, qPCR, Western blotting, and immunofluorescence, as well as assisting in data analysis, presenting findings to the team, and preparing reports to document research progress. Required Skills:
Cell Culture: Experience in culturing and maintaining a variety of cell lines, including primary cells and induced pluripotent stem cells (iPSCs).
Molecular Biology Techniques: Proficiency in analytical methods such as PCR, qPCR, and Western blotting for gene expression and protein quantification.
Data Analysis: Competence in evaluating experimental data utilizing tools such as Microsoft Excel, GraphPad Prism, or equivalent software.
Literature Review: Demonstrated ability to conduct thorough literature reviews to contextualize current research and identify gaps in knowledge.
Experimental Design: Experience in designing rigorous experiments to assess the impact of investigational molecules on gene expression and protein function.
Scientific Reporting: Ability to prepare detailed reports summarizing experimental outcomes and their broader scientific implications.
Desired Skills:
Knowledge of Cell Biology and Genetics: Understanding of gene regulation mechanisms and the effects of genetic mutations.
Immunostaining and Microscopy: Familiarity with immunostaining protocols and confocal microscopy imaging.
Team Collaboration: Proven capability to collaborate effectively with cross-functional groups, including marketing, IT, and customer service.
Presentation Skills: Advanced skills in presenting research findings to stakeholders and in scientific meetings.
Qualifications/Eligibility:
Master level degree candidate or a rising senior working towards a degree in molecular biology, biochemistry, genetics, or a related field.
Must be available to work full time, 40 hours a week.
Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program.
Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles.
Benefits of a BioMarin Internship:
Paid hourly wage, paid company holidays, and sick time
Apply skills and knowledge learned in the classroom to on-the-job experiences
Comprehensive, value-added project(s)
Develop skills specific to your major.
Opportunities for professional development by building relationships and learning about other parts of the business.
Participate in company all hands meetings, monthly community lunches
Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
Access to Employee Resource Groups
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. In the U.S., the salary range for this position is $ 24 to $32 per hour, 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.
Auto-Apply(CW) Training Associate (TEMPORARY)
Biomarin Pharmaceutical Inc. job in Novato, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Corporate Groups
It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin.
Note: This is a hybrid role. Must work onsite in Novato 2 days per week. Worker must be onsite on Tuesday or Wednesday and can choose the other onsite workday.
Job Summary:
Effective training programs are critical in a regulated manufacturing business, and this position plays an essential role in ensuring the training administration for BioMarin manufacturing and support groups are compliant with regards to GxP, regulatory and industry standards and guidelines.
The Training Specialist's primary function is to ensure our learning management system is effective and efficient. He or she will interact with customers to streamline curricula within the LMS. They will ensure that customers are adequately credited for the training necessary to properly and consistently perform their functions and assist in identifying and implementing improvements to processes that will lead to gained efficiency and reduce costs.
This position reports on the training function within the Business Operations department and supports the Novato manufacturing site and its support groups.
Responsibilities:
* Administration of the Learning Management System (LMS) to ensure seamless customer experience for the users of BioMarin manufacturing and manufacturing support groups
* Provision of training reports in support of audit and inspection
* Leading or assisting department projects as needed
LMS Administrative Requests:
* Building training curricula in association with the customer department/group
* Supporting project on migrating to paperless credit system
* Processing of training assignment requests, including curricula and user group creation and modification
* Processing Node structure changes and the associated re-grouping of personnel
* Entering training record data for non-LMS driven activities
* Integrating multiple types of e-Learning training modules into the LMS
* Creation, editing and archive of documentation as directed by department management
* Creation and delivery of custom reports as requested
* Maintain and update training database
Additional Responsibilities:
* Participate in internal and external audits and inspections
* Review documents (SOPs) and TNAs, provide feedback on the contents, and assess the training needs and requirements for new and revised procedures.
* Supporting department logistics as needed
* Deliver training as applicable
* Interact with customers across manufacturing and support groups to Address technical support inquiries
* Train on administrator tools and an ad-hoc and planned basis
* Guide/educate customers in the design of curricula and the associated implementation in the LMS to maximize efficiency and ensure consistency across learning content
* Support department logistics as needed
* Identify and recommend process improvements
* Lead or support improvement projects for training systems or programs
Required Skills:
* Administration of the LMS (ComplianceWire,Veeva, SAP etc.)
* Application of data integrity best practices in a corporate environment
* Use of web-based database software applications
* Effective customer service across all levels of business
Desired Skills:
* 2-4 years in a regulated environment supporting highly technical processes (e.g. life sciences, energy, aviation, nuclear industries)
* 4-6 years of experience in professional training
* Excellent written and verbal communication skills
* Ability to comprehend technical information related to equipment, process and regulatory expectations
* Familiarity with Biotech, Pharmaceutical and/or Medical Device Industry
* Microsoft Office Suite - Excel, Outlook, SharePoint, Visio, Word
Education:
Bachelor's Degree in technical discipline preferred (biological sciences preferred, but not
required)
Senior Patent Agent/Counsel (Large Molecule)
South San Francisco, CA job
The Position Genentech's Intellectual Property team is seeking a Senior Patent Counsel/Agent with large molecule expertise, including extensive antibody experience. As a partner and business strategist, this individual will push the boundaries of what is possible in a highly competitive industry. This position reports into the Neuroscience & CVRM IP Practice Group in Genentech's Legal Department, but may also support other therapeutic areas and modalities. Come join our passion for creating and leveraging game-changing IP strategies that enable Genentech to "do now what patients need next!" The Opportunity Key responsibilities of this individual contributor role includes the following: Managing Docket (Patent Preparation and Prosecution) * Driving strategic IP procurement and management of global intellectual property rights for individual large molecule (biopharmaceutical) candidates and products, including drafting and prosecuting patent portfolios, licensing transactions, due diligence assessments, freedom-to-operate, infringement, and validity analyses, and risk evaluation and mitigation strategies. * Managing and prosecuting active global dockets, including handling U.S. and foreign patent applications as well as post-grant proceedings (e.g., reexamination, reissue, post-grant review), including foreign oppositions and appeals, as they may arise. * Rendering due diligence assessments, freedom-to-operate, infringement, and validity analyses, and risk evaluation and mitigation strategies for individual program molecules, technologies, tools, and the like. * Identifying and exploiting new strategic opportunities and approaches by leveraging a deep understanding of patent law and a knowledge of the competitive landscape across the Genentech franchises and portfolio. Providing Advice and Counsel * Partnering effectively with relevant stakeholders at all levels of the global organization and across all phases of research, drug development, and commercialization to provide clear, strategic business enabling strategies. * Influencing business leaders as a trusted advisor and thought partner. * Deploying in-depth patent and scientific expertise to provide education, guidance, and advice on patent law issues to scientists conducting research and other business stakeholders. * Maintaining and sharing expertise and knowledge on legal case law, rules, or regulations before the U.S. Patent and Trademark Office as well as other relevant jurisdictional IP offices. Collaborating, Managing, and Supporting Teams * Partnering in all intellectual property-related transactions, adverse proceedings, and litigation activities related to individual's program responsibilities. * Participating in group, department, and cross-functional projects and initiatives where strategies, processes, operating standards, and/or practices are developed and deployed to ensure highest quality practices and execution for all aspects of IP portfolios in a high performing, agile team setting. * Sustainably building enduring, productive external relationships with outside counsel, third-party collaborators, and partners. * Ensuring that Genentech remains a great place to practice game-changing IP law, have fun, and make a difference for patients! Key Competencies Key competencies of this individual contributor role includes the following: * Exhibits poise under pressure, solution-oriented mindset, clear communication at all levels of an organization, effective collaboration across local and global teams, and active in-person presence with IP/Legal and business stakeholders. * Tackles new challenges with curiosity and a growth-mindset, effectively utilizing available resources, and an enthusiastic willingness to listen and learn from others. * Excels in working independently and proactively with minimal direction, strong organizational skills, and ability to prioritize and balance competing projects and responsibilities in a fast-paced global organization. Who You Are Qualifications and experience needed for this role include the following: * 7+ years of patent attorney/agent experience in life sciences patent prosecution, with majority of experience in patent application drafting and prosecution in a pharma/biotech corporate setting and/or representing such clients/matters in a law firm. * Admission to practice before the U.S. Patent and Trademark Office (USPTO) required. * A U.S. law degree (J.D.) and a current "good standing" admission to at least one U.S. state bar is required for attorney applicants. * An advanced degree in biological sciences such as biochemistry, molecular biology, or other areas relevant to biopharmaceutical IP practice. A Ph.D. is highly desired. * Demonstrated experience and track record of success in: *
Building and leveraging global IP portfolios for large molecule biopharmaceuticals at all stages of prosecution and enforcement; * Designing and executing complex freedom-to-operate analyses across different technologies and different jurisdictions; * Developing and communicating actionable risk mitigation strategies; * Experience in IP transactions and due diligence is a plus; * Experience in adverse IP proceedings, including but not limited to US litigation, is a plus; * Besides large molecule experience, additional experience with small molecule global IP portfolios at all stages of prosecution and enforcement is a plus; * Experience in gene therapy, cell therapy, and RNA therapeutics is a plus. This role is located onsite at Genentech's South San Francisco, California campus, and a remote working arrangement is not available. Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of California is $211,300 and $392,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Sr. Manager/Associate Director, Quantitative Science
Biomarin Pharmaceutical Inc. job in San Rafael, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
Sr. Manager/Associate Director, Quantitative Science
Summary
The Quantitative Science team at BioMarin performs statistics and data science across research and development and beyond.
As the Senior Manager or Associate Director of Quantitative Science, you will assume the role of a statistician/data scientist and play a pivotal role in supporting different functional areas. This influential and self-sufficient position will make significant contributions to drug discovery, nonclinical research, preclinical research, experimental medicine, biomarker development, clinical development, post-approval/medical areas, real-world data/real-world evidence (RWD/RWE), genomics, business development, and manufacturing.
Your primary responsibility will be to ensure excellence in the design, analysis, interpretation, and communication of data. Additionally, you will actively engage with counterparts to foster collaboration and champion the use of quantitative thinking.
The ideal candidate must demonstrate the following qualifications:
* Broad subject matter expertise in statistics and data science with hands-on experience in application in diverse areas
* Proficiency in statistics, advanced data science, and programming
* Ability to develop fit-for-purpose statistical methodologies and software tools is a plus
* Exceptional communication/interpersonal skills
Responsibilities
* Perform statistical experimental design, analysis, interpretation, and reporting, including for example
* Estimate sample size and aid in study design including conducting simulations
* Conceptualize solutions to unique challenges and develop analysis methods and analysis programs accordingly
* Explore and develop the use of artificial intelligence (AI) and machine learning (ML)
* Write statistical analysis reports and give presentations
* Develop statistical applications that enable researchers to analyze repetitive experiments
* Conduct outreach to internal functions, establishing collaborations and providing education to identify opportunities to apply statistics and data science that positively impact the business
* Provide guidance and direction to junior staff on the team
Education & Experience:
M.S. in Biostatistics, Statistics, Data Science, or similar field required.
Ph.D. in Biostatistics, Statistics, Data Science, or similar field preferred.
Minimum Qualifications
Years of experience in pharmaceutical and/or biotech industry: A minimum of 5 (PhD) or 7 (Master's) for associate director; A minimum of 2 (PhD) or 4 (Master's) for senior manager.
Preferred Qualifications:
Overall:
* Basic broad knowledge of the research, development, and associated areas in the pharmaceutical/biotechnology field
* Broad knowledge of statistical methods and ability to solve problems creatively and pragmatically
* Scientific curiosity and ability to learn
* Exceptional consultative, conversational, written communication, presenting, collaborative, teaching, and interpersonal skills
* Adaptability and ability to thrive in a dynamic, diverse, and matrixed environment
Statistics and data science:
* Hands-on knowledge of statistical methods applicable across research and development such as time-to-event analyses, analysis of covariance, mixed models for repeated measures, categorical data approaches, Bayesian methods, simulation approaches, artificial intelligence (AI) and machine learning (ML), graphical methods, etc.
* Hands-on knowledge of study design and sample size calculation
* Strong programming skills in at least two of SAS, R, or Python
Software tool development:
* Proficiency in or demonstrated ability to learn developing specifications and designing analysis modules to automate analysis, visualization, and reporting of standardized experiments; proficiency in documenting and supporting such systems
Supervisory:
* Demonstrated ability to lead, motivate, and mentor both internal and contract staff.
* Effective review and evaluation skills for documents drafted by staff.
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.
The salary range for this position is: $151,000 to $226,400. 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.
For additional benefits information, visit:
Medical Writer
Biomarin Pharmaceutical job in San Rafael, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The Medical Writer 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
RESPONSIBILITIES List the major responsibilities of the job.
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)
Aids in managing study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Assists in developing and reviewing standard processes and templates within Global Medical Writing
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned.
SCOPE Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
This position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
EDUCATION State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Bachelor's or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
Relevant ExperienceFulfills one of the following:· Up to 2 years as a medical writer in the pharmaceutical industry· At least 5 years of medical or scientific writing experience as a primary job responsibility Clinical Studies· Familiar with drug development process (discovery to market).· Basic understanding of biostatistical and clinical research concepts.· Basic applied knowledge of:o documentation required for the conduct of clinical studieso protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)o study results reporting Medical Writing· Writing high-quality documents that support corporate goals and objectives.· Experience writing, reviewing, or editing protocols and clinical study reports preferred.· Basic applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.· Ability to interpret basic tabular and graphical clinical data presentations.· Ability to create basic tables using AMA style (eg, Schedule of Events).· Basic to intermediate applied knowledge of basic clinical laboratory tests.· Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills
Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint.
Familiar with document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers.
Regulatory
Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Project Management
Capable of working on multiple tasks and shifting priorities.
Good conflict management skills.
Motivated and shows initiative.
Detail oriented.
Communication
Capable of well organized, concise and clear written and verbal communication.
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.
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.
Auto-ApplyClinical Site Lead - Los Angeles
Pleasanton, CA job
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Summary
The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Recognized resource in protocol execution, increasing product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application.
Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of site's recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.
May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee.
**Main Responsibilities**
With limited direction from leadership:
**1. Develop and** **maintain** **a productive clinical territory:**
+ Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality.
+ Understand and assess investigators' interests and qualifications.
+ Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.
+ Maintain open communication and relationships with key site personnel including the Principle Investigator, Research Coordinator, as well as regulatory and legal personnel.
+ Provide ongoing technical support to customers and field staff.
+ Facilitate communication between clinical sites and other Abbott clinical staff (e.g., operations management, study team, Site Contracts Associate), as needed.
**2. Manage all aspects of study lifecycle to include site regulatory and quality:**
Start Up
+ Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
+ Facilitate all aspects of the start-up process and site initiation visits
+ Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff, e.g. Site CRA, Site Contract Associate.
+ Train facility staff regarding protocol requirements and technology.
Enrollment
+ Develop site-specific strategies to promote appropriate patient enrollment.
+ Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.
+ Continuously evaluate site study performance and provide timely feedback to site.
+ Attend study procedures and follow-ups when indicated (or ensure trained personnel attend).
Regulatory and Quality
+ Core level Abbott certification and/or equivalent level proficiency
+ Develop site-specific strategies to avoid deviations.
+ Educate site on tools to facilitate compliance.
+ Providetimely feedback to the sites on key compliance indicators.
+ Escalate non-compliant sites according to corporate policy.
+ Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.
+ Review data and source documentation from investigational sites for accuracy and completeness
+ Facilitate resolution of data queries and action items at clinical sites
+ Promptly reports the findings of monitoring visits according to Abbott processes.
+ Maintainaccurate, detailed and complete records of monitoring visits.
**3. Provide training and procedure coverage:**
+ Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.
+ As needed, provide clinical and technical expertise for clinical trial procedure support
+ Attend study procedures and follow-ups (or ensure trained personnel attend).
**4. Collaborate with commercial partners:**
+ When appropriate, collaborate in the education of local sales groups on new product launches.
+ When appropriate, contribute to the education of customers on new and existing Abbott products.
+ Meet with key customers where Abbott GCO presence can elevate the customer experience.
+ Act as an additional resource for technical questions and troubleshooting.
**5.** **Identify** **and adapt to shifting priorities and competing demands.**
**6. Remain current on developments in the field of expertise including clinical and Abbott product knowledge, competitive positioning and published scientific and economic evidence.**
+ Maintain at least one area of expertise and function as a local clinical and technical resource.
**7.** **Possess** **independent problem-solving skills and ability to make decisions.**
**8. Exhibit excellent oral and written communication skills.**
**Require Qualifications:**
+ Bachelors Degree (± 16 years) Related field OR an equivalent combination of education and work experience
+ Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
+ Minimum 2 years Related work experience with a good understanding of specified functional area
**Preferred Qualifications:**
+ Bachelor's Degree Or Master's Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research.
+ 2 + years of progressively more responsible relevant clinical trial experience in the cardiovascular field.
+ Competency in catheterizaion lab and operating room protocol and procedures.
+ Ability to travel approximately 75%, including internationally.
The base pay for this position is $60,000.00 - $120,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call ************ or email ******************
2026 Summer Intern - Product Technical Development - Laboratory (Wet-Lab or Dry-Lab)
South San Francisco, CA job
2026 Summer Intern - Product Technical Development - Laboratory (Wet-Lab or Dry-Lab) To Apply: * As a second attachment (apart from your CV), please include a cover letter (not to exceed 1 page in length) that addresses the following questions:
* What strengths are you most proud of that you will bring to your role as an intern at Genentech?
* How does interning at Genentech fit in with your long term career goals?
* Please describe a unique situation in either your academic, personal, or career areas of your life in which you took initiative that had a meaningful impact on either your school, community, or an organization.
Department Summary
Pharmaceutical Technical Development (PTDU) develops, delivers, and supports robust, cost-effective production methods and technologies for innovative therapeutics to meet the needs of Genentech's Research, Development, Commercial, and Product Operations groups. The group has long been recognized as a world leader in developing large-scale manufacturing processes, sophisticated analytical methods, and effective drug delivery systems.
This internship position is located in South San Francisco, on-site
Program Highlights
* Six Months (with a possible 6-month extension), (40 hours per week) paid internship.
* Program start dates are in May/June 2026.
* A stipend, based on location, will be provided to help alleviate costs associated with the internship.
* Ownership of challenging and impactful business-critical projects.
* Work with some of the most talented people in the biotechnology industry.
* Final presentations of project work to senior leaders.
* Lead or participate in intern committees to design and coordinate program events and initiatives.
* Professional & personal development curriculum throughout the program, including networking opportunities, workshops, and panel discussions.
* Participate in volunteer projects, social events, and team-building activities.
The Opportunity
As a Technical Development Intern, Laboratory focus, you may be assigned a project in one of the following areas within PTDUP:
* Cell Culture and Fermentation Development
* Purification Development
* Protein Analytical Chemistry
* Analytical Operations
* Pharmaceutical Development
* Drug Delivery Technology Development
* Potency Assay Development
* Cell and Gene Therapies
This program provides a broad perspective and appreciation of the development of new processes, methods, and technologies at different production scales in the biotechnology industry.
Candidates applying for the PTDU Intern Program should be passionate about science/engineering and thoroughly enjoy the challenges associated with complex problem-solving. Candidates must be highly self-motivated and able to work effectively as individuals and as part of multi-disciplinary teams in an atmosphere of casual intensity to develop medicines for unmet medical needs.
Interns with a laboratory focus will work alongside scientists to design, execute, and analyze wet-lab or dry-lab-based experiments in support of the diverse development activities needed to produce therapeutics at scale for patients. Previous internship projects have included but are not limited to:
* Cell and molecular biology approaches to develop novel drug potency assays.
* Bioreactor, fermentation, and cell culture media studies.
* Drug analysis using tools like mass spectrometry, HPLC, NMR
* Protein structure and stability studies.
* Developing cell differentiation protocols in support of cell therapy programs.
* Updates to the PTDU Assay Information & Request (PAIR) System.
* Benchling templates and results schema update.
Required Education
You meet one of the following criteria:
* Must be pursuing a Bachelor's degree (enrolled student graduating in 2026 or 2027).
* Must have attained a Bachelor's degree no more than 2 years ago from the time of application (not currently enrolled in a grad program).
* Must be pursuing a Master's degree (enrolled student).
* Must have attained a Master's degree no more than 2 years ago from the time of application.
Required Majors: Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Bioengineering, Pharmaceutical Engineering, Chemistry, Biology, Microbiology, Biophysics, or related disciplines.
Preferred Knowledge, Skills, and Qualifications
* Detail-oriented, enthusiastic, and self-directed individual who is excited about tackling complex and creative scientific challenges in an industrial setting.
* Excellent communication, collaboration, and interpersonal skills.
* Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion.
* Ability to show a high degree of adaptive capacity.
* Relevant work experience in research labs or the biotechnology industry.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location for this position in California is $30.00 - $40.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Maintenance Mechanic 1 (Grave Shift)
Biomarin Pharmaceutical Inc. job in Novato, CA
About Technical Operations 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.
Job Description
Position: Maintenance Mechanic 2 (Graveyard Shift)
Job Summary
This is a Graveyard Shift position, Sunday through Wednesday, 0830PM-0700AM. Responsible for the operation and preventive maintenance (per SOP requirements) of all purified system (RO, DI, WFI) and associated equipment, pure steam generators, Plant Steam, utilities, process and manufacturing equipment.
Key Responsibilities
* Makedailyplannedinspectionoffacilitiesequipmentand services. Actingasrequired.
* SMEonat least1systemorequipment. (Utility or process).
* Perform various projects including plumbing, electrical,andmechanicalprojects.
* Executepreventativemaintenanceandrepairworkorders.
* Abletoindependentlyperformpreventivemaintenanceorrepairworkorderswithlittleornooversight.
* Maintaindetailedandaccuraterecordsasnecessary,tomaintain GMPanddepartmentprocedurecompliance.
* ReviseStandardOperatingProcedureswhenrequired.
* Start-upnewmechanicalsystemsunderthedirectionofa Sr.Mechanic.
* Performtroubleshooting,evaluation,andrepairofutilityandprocesssystems.
* MaintainqualityandintegrityofpreventivemaintenancedocumentationusingtheCMMSsystem.
* AssisttheMaintenancePlannerorScheduleronscopeofworkwhenrequired.
* ProvidebackupassistancefortheSupervisororleadmechanicwhenrequired.
* Otherprojects/tasksasassignedbysupervisorormanagement.
* Maintaincommunicationbetweeneachmaintenanceshiftsviatheshift pass down updates.
* Mustbeabletolift50lbs.
* ParticipateasaBERTteammember.
Experience
Minimum2+years 'experience in highly regulated industry or GMP environment.
Desired Skills
* 5 +years'experiencein Biotech
* Technicalknowledge
* Detailedattentiontomachinerymaintenance
* Adherencetostrict quality standards
* Thorough documentation
* Strongproblem-solvingabilities
* Excellentcommunicationskills
Education
High School Diploma
Collegedegree (Associates/Bachelors), TechnicalCertification,militarytechnicaltraining,orequivalentexperienceor Journeymanskilllevelinatrade.
Equipment
Utilities:
Purified water systems (RO,DI,WFI) andassociatedequipment,puresteamgenerators,plantsteamboilers, air compressors, vacuum systems,chillers, HVACunitsandassociatedequipment,hotwater,waste treatment andothermiscellaneousequipment.
Process:
Autoclaves,Glasswarewasher,Bioreactors,Chromatographyskids,MediaandBuffertanks,CIPskids,fermenters,Ultrafiltration, cold rooms, HTST system,Homogenizer,Centrifuges,heattanks, cold roomsandsomeotherassociatedequipment.
Contacts
* Manufacturing
* Facilities/Calibration
* QA/QC/Validation
* Compliance/PartsandScheduling/Training
* Engineering
Shift Details
* GraveyardShift(0830PM-0700AM)
* Sunday through Wednesday
Onsite, Remote, or Flexible
Thispositionwillbestrictlyonsite
Travel Required
No
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.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
The salary range for this position is: $57,600 to $79,200. 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.
For additional benefits information, visit:
Sr Engineer 1, Facilities & Utilities
Biomarin Pharmaceutical Inc. job in San Rafael, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Corporate Groups
It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin.
Job Title: Sr. Engineer 1, Facilities & Utilities
Location: San Rafael, California
Reports To: Associate Director Site Operations
SUMMARY DESCRIPTION
The Site Operations, Facilities & Engineering Group provides technical support, guidance, and strategic vision to ensure that the facilities, utilities, warehouse, and laboratory equipment for BioMarin's domestic operations are designed, operated, and maintained in a manner consistent with regulatory agencies, environmental health & safety and asset lifecycle management best practices.
This role will manage external vendors and contractors within a site-based Facilities & Engineering team dedicated to supporting operations across Northern California locations. Reporting to the Associate Director Site Operations you will work closely with REWS, California Facilities & Engineering, Procurement and Laboratory Operations. This role enables the teams at Biomarin to focus on its patient-centered mission, delivering first-in-class and best-in-class therapeutics that provide meaningful advances for those with serious and life-threatening rare genetic diseases.
The engineer will be responsible for ongoing support to non-GxP site operations across Northern California campuses to ensure utilities, facilities and equipment performs per its intended use and function. The engineer will be responsible for supporting the design, engineering, and commissioning of new or modified utility systems, as well as non-GxP facilities, laboratory spaces, and administrative office buildings. The engineer will be responsible for supporting the project portfolio of operational expenditure (Opex) and capital expenditure (Capex) projects at each campus, providing facility engineering and equipment advisement, participating in asset lifecycle management (ALM), facility long range planning, and initiating team improvement projects.The engineer will:
* Interact collaboratively with key customers, peers, and other stakeholders to support achieving BioMarin tactical and strategic goals & objectives.
* Highlight and submit improvement and investment projects related to facilities and utilities systems.
* Work with end users to develop system requirements, specification of equipment/buildings, review design from outside engineering firms or contractors (as needed).
* Participate in long-term strategic development of site utility system, facilities and energy efficiency programs.
* May be requested to support other opportunities as directed by management.
* Work closely with other support groups such as Maintenance, Metrology, Automation, Capital Projects, EHS&S, Facilities, Laboratory Operations and Security to assure that BioMarin assets are well managed throughout their lifecycle.
* Provide coaching, mentoring and guidance for junior engineers and may be designated as a subject matter expert for one or more clean/dirty utility systems.
RESPONSIBILITIES
* Represent the Engineering, Facilities and Services department, collaborate, and provide advisement on non-GMP facility, utility, and equipment capital projects for Northern California campuses.
* Monitor and report on the status of the non-GxP campus goals and objectives to ensure they are aligned with BioMarin enterprise strategy.
* Provide Engineering support of non-GxP laboratories and their associated Facilities/Utilities systems.
* Act as the Facilities Engineering resource on cross-functional project teams.
* Collaborate, monitor, and evaluate the asset lifecycle management of non-GMP related facility systems, utility systems and equipment, assess failure risks and asset replacement planning activities.
* Consult on the long-range planning to ensure asset replacement is scheduled and budgeted to ensure the continuity and availability of business facilities.
* Partner with EHS&S to support the emergency response team to ensure business continuity and ensure all BioMarin safety policies, procedures, standards, and practices are followed.
* Successfully plan, execute, and deliver ad-hoc requests, tasks and activities as needed from end users and customers.
* Demonstrate leadership ability including the ability to lead, motivate, develop, and directly/indirectly manage others effectively.
* Advance safety, health, and environmental stewardship at BioMarin through technical decisions, guidance, and leadership.
* Effectively manage internal and external relationships with customers, key stakeholders, and vendors.
* Demonstrate the ability to be self-directed with limited guidance and oversight from management.
* Support and drive the development of internal engineering practices and procedures.
* Effectively apply independent judgment utilizing BioMarin policies, industry practices and BioMarin standards as guidance.
* Actively participate in technical, tactical, and strategic reviews/discussions.
* Remain current on all training requirements.
* Demonstrate the ability to plan and implement small projects.
* Identify and champion projects and continuous improvement (CI) initiatives that will successfully support BioMarin business goals and objectives.
* Stay current with leading edge technologies, alternative energy strategies, sustainability trends and best practices through contacts with industry, service/equipment providers, and other formal/informal means.
* 2 days on site minimum up to 4 days per week presence required with additional time necessary depending on activities.
* Other duties as assigned.
EDUCATION
BS or MS in Chemical, Mechanical, or other Engineering degree from an accredited university. Relevant job and years of experience may be substituted in place of a degree.
EXPERIENCE
* A minimum of 5-7 years' experience in engineering, facilities/lab operations and clean/dirty plant utilities, preferably in the biotechnology or pharmaceutical industry.
* Highly proficient in deploying, managing, and improving an asset lifecycle management framework, policies, procedures, and practices, conducting equipment risk assessments, maintaining critical asset information, monitoring asset failure history, and recommending asset replacement schedules.
* Proficient in the relevant aspects of current Good Manufacturing Practices (cGMP), Good Clinical Practices (cGCP) and Good Laboratory Practices (cGLP)
* Demonstrated successful engineering support of capital projects ranging from $1M to $10M.
* An understanding and awareness of latest industry standards of environmental sustainability integration to the biopharmaceutical sector (e.g. knowledge of ISO 50001)
* Demonstrated engineering Subject Matter Expertise (SME) in at least one of the following systems: RO/DI, Clean Dry Air (CDA), clean process gas systems, HVAC, Plant Steam, Chilled water, Condenser Water, Process Wastewater, refrigeration, or electrical systems
* Strong organization, interpersonal, oral, and written communication skills.
* Strong analytical and problem solving abilities with strong capability in lab facility related technology.
* Ability to work in a fast paced, dynamic environment with a high level of Integrity.
* Proficiency with standard office software applications, including MS Outlook, MS Word, MS Excel, MS Power Point.
* Proficient in utilizing Purchase Order and Spend Management Systems (e.g., Coupa, SAP, Ariba)
* Proficiency in creating, editing, and reviewing, engineering/architectural drawings is required.
* Experience in the use of engineering software tools (e.g. CAD, Bluebeam).
* BMS JCI MetaSys related experience a plus.
WORK ENVIRONMENT / PHYSICAL DEMANDS
* While primarily a day shift job, hours will vary based on the needs of the position. This position may require additional hours and weekend/holiday work depending upon various facility requirements.
* Provide after-hours leadership/managerial on-call support as required.
* While performing the duties of this job the employee is frequently required to stand, walk, sit, talk, or hear, reach with hands and arms, climb stairs or ladders, balance, stoop, kneel, or crouch.
* Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Lead other Engineers from the team as required. Engineers can be assigned to work with the Engineer to support relevant activities in their area.
* Lead external consultants to complete critical activities and deliver compliant work on schedule and within budget.
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.
The salary range for this position is: $116,000 to $159,500. 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.
For additional benefits information, visit:
Intern, Clinical Pharmacology
Biomarin Pharmaceutical Inc. job in San Rafael, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
SUMMARY:
The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry.
The Clinical Pharmacology group is responsible for the design, execution, interpretation, and reporting of nonclinical and clinical pharmacology aspects of BioMarin's development and commercial pipeline. This includes the assessment of PK/PD relationships of small molecule, biologic and gene therapy drug candidates that are situated throughout all stages of development(Phase 0-IV). Team members are responsible for the planning, implementation, and organization of regulatory filings along with presentation of clinical pharmacology data to internal cross-functional teams, external collaborators, US and ex-US regulatory authorities and the scientific community.
JOB DESCRIPTION/PROJECT:
The Clinical Pharmacology Intern will be responsible for the design, analysis, interpretation, and reporting of PK/PD studies in support of molecules in nonclinical and clinical development. This individual will work with Clinical Pharmacology leaders on projects and provide support in designing the Clinical Pharmacology strategy with an emphasis on dose and regimen selection. The assignment will be related to core clinical pharmacology activities with specific tasks targeted to answer key development questions and achieve short-term goals for the department. The assignment will span a period of 10-12 weeks concluded with an internal presentation of results of project to leadership & publish the findings at a scientific conference.
Required Skills:
* Strong training in PK/PD analyses with a preference for population-based modeling and simulation
* Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis software
* Excellent writing and verbal communication skills
Desired Skills:
* Experience in clinical/nonclinical PK/PD study design, implementation, and interpretation
* Ability to work in a matrix environment and with different leadership styles
Qualifications/Eligibility:
* Graduate level student with a strong interest in Clinical Pharmacology, Pharmacokinetics, PK/PD Modeling and Simulation
* Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program
* Must be available to work 40 hours a week
* Must be authorized to work in the United States without visa sponsorship
Benefits of a BioMarin Internship:
* Paid hourly wage, paid company holidays, and sick time
* Apply skills and knowledge learned in the classroom to on-the-job experiences
* Comprehensive, value-added project(s)
* Develop skills specific to your major.
* Opportunities for professional development by building relationships and learning about other parts of the business.
* Participate in company all hands meetings, monthly community lunches
* Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
* Access to Employee Resource Groups
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.
In the U.S., the salary range for this position is $ 24 to $32 per hour, 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.
(CW) QA Associate (TEMPORARY)
Biomarin Pharmaceutical Inc. job in Novato, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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.
This is a Contract role-Onsite 5 days per week in Novato, CA. Possibility of working offsite when fully trained*
QA Associate
Description:
This position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities. The QA Associate will have proven capability in promoting Quality across cross-functional teams, to deliver high quality product, ensuring continuous process improvement. The QA Associate will model the BioMarin Leadership behaviors and understand the principles to drive a culture of continuous improvement building a High-Performance Organization.
General QA Associate Responsibilities:
â—ŹExercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.
â—ŹProvide Quality input to Deviations ensuring scope of record is clear and investigations are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
â—ŹParticipates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply, Distribution, Maintenance, Metrology, and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements. Minimizing impact to Lot Release operations on site.
â—ŹPrioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
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.
In the U.S, the salary range for this position is $ 31 to $ 50 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $31 to $50. 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.
For additional benefits information, visit:
(CW) Research Associate (TEMPORARY)
Biomarin Pharmaceutical Inc. job in San Rafael, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
Contract role in This role is onsite five days a week in San Rafael, CA*
The Research & Early Development (RED) group is responsible for everything from research and discovery to post-market clinical development. RED involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.
Summary Description:
Gain industry experience and learn various skills to become a well-rounded scientist capable of advancing drug development. The individual will assist senior staff in planning, performing, and documenting laboratory experiments.
Primary responsibilities may include general lab duties, buffer preparation, animal tissue processing, analytical pathology techniques including tissue sectioning (microtomy and cryotomy), histologic staining (e.g. H&E & Masson's trichrome), immunohistochemistry, In Situ Hybridization, and brightfield and epifluorescence microscopy. Other responsibilities include qualitative and basic, quantitative image analysis (Visiopharm), and preparation of image data for power points and reports.
The ideal candidate will be responsible for performing, and/or supporting the development and optimization of experimental systems. This role conducts lab-based experimentation based on literature protocols, standard operating procedures (SOPs), consulted innovative approaches, and conducts general laboratory maintenance responsibilities. This role performs data analysis with appropriate documentation of all methods used and proper handling of raw data.
Experience & Education per level:
Research Associate 1:
Bachelor's degree and at least 1-2 years of relevant experience
Work Environment/Physical Demands:
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, crawl, and smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus. Wet lab environment. Some toxic chemical use. Occasional foul odors. Candidate must not have any known chemical allergies.
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.
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.
In the U.S, the salary range for this position is $ 31 to $ 50 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $31 to $50. 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.
For additional benefits information, visit:
(CW) Accounts Payable Analyst (TEMPORARY)
Biomarin Pharmaceutical Inc. job in San Rafael, CA
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Corporate Groups
It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin.
This is a Contract role for one year/contract to Full Time- (2 days in-office, 3 days WFH)
Location: San Rafael
Key Responsibilities of the position include, but are not limited to:
* Manage account reconciliations and resolve discrepancies across AP and related accounts.
* Review and process complex AP transactions while ensuring adherence to company policies.
* Determine root cause for invoice/supplier issues. Submit and track IT tickets, initiate meetings and work with internal support staff to resolve invoicing/supplier issues.
* Backup to AP Mailbox Coordinator when they are out of the office.
* Assist with month-end close activities, including clearing account discrepancies and variance analysis
* Investigate AP exceptions, identify trends, and recommend corrective actions.
* Support the AP Manager in refining processes and improving accuracy in reporting.
* Develop and document best practices for reconciliation and AP workflows.
* Any special projects/tasks assigned by management.
Qualifications
* Degree in Finance or Accounting preferred
* 1-2 years Accounts Payable Experience
* Strong knowledge of core accounting concepts
* Knowledge of control concepts (segregation of duties, verification, security, etc.)
* Ability to exercise good judgement and effective written and verbal communication skills
* Experience in diagnosing, isolating, and resolving issues, and recommending and implementing strategies to resolve problems
* Experience in Oracle and/or SAP a plus
* Competent in Microsoft Office, including Excel
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.
In the U.S, the salary range for this position is $ 31 to $ 50 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $31 to $50. 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.
For additional benefits information, visit:
Intern, Project Manager, Clinical Development
Biomarin Pharmaceutical job in San Rafael, CA
Description Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. SUMMARY:The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry. Over the course of 10 - 12 weeks our interns gain industry experience while working alongside our talented team on meaningful projects. As part of the BioMarin R&D Project Management Organization (PMO), the Intern Project Manager supports and drives the efficiency and effectiveness of cross-functional sub-teams in partnership with the Project Managers through meeting management, timeline development / management / tracking, and cross-functional communications. The PMO sits within BioMarin Research and Development (R&D), and the intern will have the opportunity to see a broad scope of drug development with the ability to interact with scientists and professionals across the organization. JOB DESCRIPTION/PROJECT:The intern's primary project would be to:
Work closely with the Clinical Development PM to propose a new structure and content plan for the PMO SharePoint site
Engage with representatives from each PMO branch to understand their roles and contributions to drug development.
Gather and organize key resources and documentation to improve accessibility and transparency.
In collaboration with the Clinical Development PM, other responsibilities may include:
Tracking project and program timelines, drive action item completion, and document decision making for CDTs.
Scheduling clinically focused meetings, generate the agenda and facilitate the meeting (in collaboration with the team lead), and document/distribute minutes and action items
Identifying opportunities for standardization or process efficiencies based on cross-functional insights.
Attend cross-functional team meetings and Production Integration Management Team (PRIME) team meetings to develop an understanding of clinical development.
Required Skills:
Developing skills in decision making and problem solving
Communication
Leadership
Microsoft Office
Desired Skills:
Drug development and product knowledge
Team and stakeholder management and communication
Process improvement
Qualifications/Eligibility:
In progress bachelor's degree in health or life sciences, including chemistry, molecular biology, or similar
Must be available to work full-time, 40 hours a week.
Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program.
Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles.
Benefits of a BioMarin Internship:
Paid hourly wage, paid company holidays, and sick time
Apply skills and knowledge learned in the classroom to on-the-job experiences
Comprehensive, value-added project(s)
Develop skills specific to your major.
Opportunities for professional development by building relationships and learning about other parts of the business.
Participate in company all hands meetings, monthly community lunches
Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
Access to Employee Resource Groups
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. In the U.S., the salary range for this position is $ 24 to $27 per hour, 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.
Auto-Apply2026 Summer Intern - Frontier Research, Prescient Design
South San Francisco, CA job
The Frontier Research team within Prescient Design seeks exceptional graduate student interns with a demonstrated research background in statistics and/or machine learning, a passion for independent research and technical problem-solving, and a proven ability to develop and implement research ideas.
This on-site/in-person internship position is located in South San Francisco, CA.
The Opportunity
Participate in cutting-edge research advancing statistical and machine learning methods for the design and analysis of clinical trials.
Develop well-documented code to facilitate adoption of the methods.
Prepare a manuscript for submission to a scientific journal and/or conference.
Program Highlights
Intensive 12-week, full-time (40 hours per week) paid internship.
Program start dates are in May or June 2026.
A stipend, based on location, will be provided to help alleviate costs associated with the internship.
Who You Are
Required Education:
Must be pursuing a Ph.D. (enrolled student).
Required Majors:
Statistics, Computer Science, Biostatistics, Applied Math, Physics, or related technical field.
Required Skills:
Excellent and proactive communication, collaboration, and interpersonal skills.
Strong background and research experience in applied and/or theoretical statistics, as demonstrated by publications in statistics journals or conferences such as AISTATS, ICML, NeurIPS, etc.
Strong software development skills in Python.
Preferred Qualifications:
Prior experience working with clinicogenomic, electronic health record, or other patient biomedical data is a plus, but not required.
Familiarity with survival analysis is a plus, but not required.
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of California is $50.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Auto-ApplySAP Business Analyst Lead - Record to Report (R2R) Workstream
Biomarin Pharmaceutical job in San Rafael, CA
Description Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
Overview: We are seeking an experienced SAP Business Analyst Lead to spearhead the Record to Report (R2R) workstream, with a focus on Treasury and Banking, Finance and Controlling (FICO), Profitability and Performance Management (PaPM), and Financial Planning & Analysis (FP&A). The SAP Business Analyst Lead will play a critical role in designing, implementing, and optimizing SAP solutions to support end-to-end financial processes, ensuring alignment with business objectives and operational excellence. Sr. Manager level. Hybrid role, requiring 2 days/week onsite at HQ in San Rafael, CA Key Responsibilities:
Solution Design and Implementation:
Lead the design, configuration, and deployment of SAP modules and functionalities within the R2R workstream, including SAP FICO, Treasury (TRM), SAP MBC, PaPM, and FP&A solutions.
Collaborate with business stakeholders to gather and analyze requirements for financial processes, ensuring alignment with organizational goals.
Develop and maintain functional specifications, process flows, and system configurations to support R2R processes.
Process Optimization:
Drive process improvements in financial close, general ledger, accounts payable/receivable, asset accounting, cost center accounting, and profitability analysis.
Optimize treasury and banking processes, including cash management, liquidity forecasting, payment processing, and bank communication (e.g., SWIFT, SEPA).
Enhance FP&A capabilities through SAP SAC solutions, enabling robust budgeting, forecasting, and performance reporting.
Leverage SAP PaPM to support Transfer Pricing, profitability analysis, cost allocation, and performance management initiatives.
Leadership and Collaboration:
Lead a team of business analysts and coordinate with cross-functional teams (e.g., SAP technical consultants, integration specialists, and business users) to deliver R2R solutions.
Act as the primary point of contact for R2R-related inquiries, providing guidance to stakeholders and resolving complex issues.
Facilitate workshops, Cross Functional Collaboration, training sessions, and change management activities to ensure user adoption and process alignment.
System Integration and Data Management:
Ensure seamless integration of SAP R2R modules with other SAP and non-SAP systems (e.g., SAP S/4HANA, or third-party banking platforms).
Oversee data migration, master data management, and data quality initiatives for financial and treasury processes.
Compliance and Reporting:
Ensure compliance with financial regulations (e.g., IFRS, GAAP) and internal controls (e.g., SOX) within SAP configurations.
Support the development of financial reports, dashboards, and analytics to meet stakeholder needs in FP&A and PaPM.
Project Management:
Manage R2R workstream deliverables, timelines, and budgets within SAP implementation or enhancement projects.
Collaborate with project managers to align R2R activities with overall program objectives.
Qualifications:
Education: Bachelor's degree in Finance, Accounting, Information Technology, or a related field. MBA or relevant certifications (e.g., SAP Certified Application Associate, CPA, CMA) are a plus.
Experience:
7+ years of experience as an SAP Business Analyst, with at least 3 years in a lead or senior role focused on R2R processes.
Proven expertise in SAP FICO, Treasury, PaPM, and FP&A modules, preferably within SAP S/4HANA environments.
Hands-on experience with treasury processes (e.g., cash management, bank reconciliation, liquidity forecasting) and banking interfaces.
Strong knowledge of financial close, general ledger, cost accounting, and profitability analysis.
Technical Skills:
In-depth understanding of SAP modules (FICO, TRM, PaPM, SAC for FP&A) and their integration with other SAP components.
Familiarity with SAP configuration, master data setup, and reporting tools (e.g., SAP Fiori, SAP Analytics Cloud).
Knowledge of financial regulatory requirements and compliance standards (e.g., IFRS, GAAP, SOX).
Soft Skills:
Exceptional leadership, communication, and stakeholder management skills.
Strong analytical and problem-solving abilities, with a focus on process optimization.
Ability to work in a fast-paced, collaborative environment and manage multiple priorities.
Exemplifies professionalism and emotional intelligence, ensuring effective collaboration, clear communication and the ability to navigate complex situations with tact and maturity.
Preferred:
Experience with SAP S/4HANA implementations or upgrades is a must.
Familiarity with Agile or hybrid project methodologies.
Knowledge of advanced analytics or AI-driven financial tools is a plus.
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.
Auto-Apply