Manufacturing Sciences & Technology (MSAT) * Manufacturing, Quality Control, and Quality teams ... Support regulatory inspections, audits, and site readiness activities Data Management ...
Manufacturing Sciences & Technology (MSAT) * Manufacturing, Quality Control, and Quality teams ... Support regulatory inspections, audits, and site readiness activities Data Management ...
Sr. Scientist 1
Novato, CA · On-site
$107K - $146K/yr
... and management. This role also serves as the scientific monitor for formulation development ... Collaborates within a matrix organization (Research, PD, QC, Drug Substance, Analytical, MSAT ...
Sr. Scientist 1
Novato, CA · On-site
$107K - $146K/yr
... and management. This role also serves as the scientific monitor for formulation development ... Collaborates within a matrix organization (Research, PD, QC, Drug Substance, Analytical, MSAT ...
Sr. Scientist 1
Novato, CA · On-site
... Analytical, MSAT, Manufacturing, CDMOs/CMOs, Market Planning, Regulatory) to deliver project ... Strong leadership and team management skills. A strong team player with good collaborative and ...
Sr. Scientist 1
Novato, CA · On-site
... Analytical, MSAT, Manufacturing, CDMOs/CMOs, Market Planning, Regulatory) to deliver project ... Strong leadership and team management skills. A strong team player with good collaborative and ...
Msat Manager information
What is an MSAT Manager?
An MSAT (Manufacturing Science and Technology) Manager is a professional responsible for overseeing the technical aspects of manufacturing processes in industries such as pharmaceuticals and biotechnology. They ensure that production processes are efficient, compliant with regulations, and optimized for quality and yield. The MSAT Manager works closely with production, quality assurance, and R&D teams to troubleshoot issues, implement process improvements, and support technology transfer. Their role is critical in ensuring that products are manufactured consistently and safely, meeting all industry standards.
What are some typical challenges an MSAT Manager faces when transferring new manufacturing processes to large-scale production?
As an MSAT (Manufacturing Science and Technology) Manager, one of the primary challenges is ensuring that processes developed at the laboratory or pilot scale are robust and reproducible when scaled up for commercial manufacturing. This often involves troubleshooting unexpected technical issues, managing cross-functional teams, and ensuring compliance with regulatory standards. Effective communication and collaboration with process development, quality assurance, and operations teams are essential to address these challenges and ensure a smooth technology transfer.
What are the key skills and qualifications needed to thrive as an MSAT Manager, and why are they important?
To thrive as an MSAT (Manufacturing Science and Technology) Manager, you need a strong background in biochemical engineering, process development, and GMP manufacturing, typically supported by a relevant degree. Familiarity with process analytical technology (PAT), statistical process control tools, and quality management systems is essential, and certifications like Six Sigma can be advantageous. Strong leadership, problem-solving, and communication skills help drive cross-functional collaboration and process improvements. These skills and qualities are vital to ensure efficient, compliant, and innovative production processes in highly regulated biomanufacturing environments.
What is the difference between Msat Manager vs Msat Engineer?
| Aspect | Msat Manager | Msat Engineer |
|---|---|---|
| Credentials | Typically requires a bachelor's degree in engineering or related field, with some roles preferring certifications like PMP or Six Sigma | Requires a bachelor's degree in engineering, with some positions favoring certifications like Six Sigma Green Belt |
| Work Environment | Leads teams, manages projects, and oversees process improvements in manufacturing or industrial settings | Focuses on designing, analyzing, and implementing manufacturing processes, often working hands-on with equipment |
| Employer & Industry Usage | Commonly employed in manufacturing, automotive, and industrial sectors for process optimization | Used in similar industries, emphasizing technical process development and troubleshooting |
The Msat Manager typically holds a leadership role, overseeing teams and projects, while the Msat Engineer focuses on technical process design and analysis. Both roles require engineering backgrounds and are integral to manufacturing process improvements, but the manager has broader responsibilities in team and project management.
Research Associate 1, Process Analytics and Services (Analytical Sciences)
Novato, CA • On-site
BIOMARIN PHARMACEUTICAL
• Biotechnology Research and Development • 1 - 5K employees1,001 - 5,000 employees
Full-time
Re-posted yesterday
BioMarin Pharmaceutical rating
7.8
Based on 8 frontline employees who took The Breakroom Quiz
Job 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 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.
SUMMARY
The Analytical Sciences department is seeking a Research Associate 1 to join the Process Analytics & Services (PAS) function. This is a hands-on laboratory role supporting analytical testing and characterization of therapeutic candidates across process development, early clinical, late-stage, and commercial programs.
The selected candidate will execute a variety of GxP and non-GxP analytical methods to support drug substance and drug product process development, method lifecycle activities, and cross-functional technical investigations. This role requires strong laboratory execution, data analysis, and collaboration skills in a fast-paced, multi-disciplinary environment.
KEY RESPONSIBILITIES
Analytical Testing & Data Execution
- Perform routine and non-routine analytical testing to support process development (Drug Substance and Drug Product) and lifecycle programs
- Execute assays including:
- Chromatographic methods (e.g., HPLC/UPLC)
- Capillary electrophoresis (CE) and gel-based electrophoresis (e.g., SDS-PAGE)
- Spectrophotometric methods (e.g., UV/Vis, FTIR)
- Plate-based assays (e.g., ELISA) and cell-based bioassays
- Basic nucleic acid and compendial physicochemical testing
- Accurately document test results in accordance with GMP/GLP and internal procedures
- Analyze and interpret analytical data and communicate results clearly
Method Lifecycle & Laboratory Support
- Support method qualification, optimization, validation, and transfer activities under supervision
- Assist with drafting and updating technical documents (e.g., analytical procedures, protocols, reports)
- Support troubleshooting of analytical methods and laboratory workflows
- Maintain laboratory equipment and ensure readiness of reagents, standards, and materials
Process Development & Cross-Functional Support
- Provide analytical testing support for process development, manufacturing, and investigation activities
- Collaborate with cross-functional teams including:
- Drug Substance Technologies (DST)
- Formulation and Drug Product Technologies (FPT)
- Manufacturing Sciences & Technology (MSAT)
- Manufacturing, Quality Control, and Quality teams
- Support in-process, release, and stability-related analytical testing
Compliance & Inspection Readiness
- Ensure all work is performed in accordance with GxP requirements and BioMarin procedures
- Maintain laboratory documentation and data in an inspection-ready state
- Support regulatory inspections, audits, and site readiness activities
Data Management & Communication
- Document experimental plans, results, and conclusions clearly and accurately
- Maintain organized electronic records to ensure traceability and data integrity
- Present data and progress updates in team meetings
Continuous Improvement & Team Support
- Contribute to improvement of laboratory processes, workflows, and documentation practices
- Support training and knowledge sharing within the team as appropriate
REQUIRED SKILLS
- Hands-on experience with one or more analytical techniques (e.g., HPLC/UPLC, CE, ELISA, spectrophotometry)
- Basic understanding of GMP/GLP principles and data integrity expectations
- Ability to analyze and interpret data
- Strong written and oral communication skills
- Strong organizational skills with the ability to manage multiple tasks
- Ability to work independently and collaboratively in a team environment
PREFERRED SKILLS
- Hands-on experience with chromatographic (LC/HPLC/UPLC) and capillary electrophoresis (CE) methods
- Exposure to biopharmaceutical development or protein characterization
- Experience with bioassays or cell-based assays
- Familiarity with analytical method lifecycle activities (e.g., qualification, troubleshooting, validation, or transfer)
- Experience working in a cross-functional or fast-paced environment
EDUCATION & EXPERIENCE
- Bachelor's degree in Biochemistry, Chemistry, Biology, Analytical Chemistry, or related field
- 1-2 years of relevant experience in a pharmaceutical or biotechnology environment
- Master's degree is a plus but not required
ADDITIONAL INFORMATION
- This is a fully onsite laboratory role
- Routine work includes handling chemicals and biological materials with appropriate safety practices
- May require occasional flexibility to support operational needs
EQUIPMENT
Operation of standard laboratory equipment for biochemistry and for cellular assays
REPORTING STRUCTURE
- Reports to: Sr. Manager, Process Analytics & Services
- No supervisory responsibilities
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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.
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About BioMarin Pharmaceutical
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
San Rafael, CA, US
Year founded
1997