MSAT Process Engineer/Scientist
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
BioMarin has a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.
The MSAT Manufacturing Interface Scientist / Process Engineer will be the primary contact with Manufacturing for a given product prior to, during and post-campaign. Their primary role is to ensure that the manufacturing process performs as expected while ensuring continuous process improvement through the application of scientific and engineering expertise. This role will require technical understanding in cell culture and/or protein purification science and technology.
The role involves high levels of cross functional collaboration in areas such as technology transfer, process scale up, process optimization and continuous improvement. The role will combine scientific, engineering and operational leadership. The MSAT Scientist / Process Engineer will learn deep skills in Root Cause Analysis, Statistical Analysis, Data Modeling and Experimental Design. The Scientist / Process Engineer will also be able to demonstrate impactful communication of complex scientific and engineering concepts to non-technical audiences.
Furthermore, this position requires a high degree of familiarity with cGMP and Quality Systems involved with both clinical and commercial manufacturing processes.
· Interpret complex technical challenges and provide resolutions to enable decisions.
· Prioritize effectively and manage multiple priorities in a fast-pace work environment
· Work closely with the other MSAT Team members, be engaged in the planning of experiments resulting from campaign learnings to increase process robustness and reduce Cost of Goods Sold (COGS)
· Lead and provide constructive challenge during process investigations and steer investigations to be data driven, risk-based and comprehensive.
· Provide technical input to technology transfer related documents (e.g. clinical and commercial protocols, batch records, PV documents, equipment user requirements)
· Ensure process training is provided to MFG operations staff on a campaign basis.
· Utilize fundamental engineering principles relevant to bioprocess unit operations for scale-up, facility fit and technology transfer.
· Provide training for new personnel on the process and prior to each campaign.
· Provide technical direction in troubleshooting and optimizing ongoing manufacturing upstream/downstream unit operations.
· Monitor production process and trends and lead the analysis and communication of the results.
· Provide manufacturing with critical information necessary for maintaining consistent product supply, now and in the future.
· Lead/participate in the diagnosis and resolution of production problems.
· Ensure accurate and complete documentation of any scientific experimental plan, data and report.
· Test the feasibility of new manufacturing processes.
· Potentially act as an SME and participate in the execution of small-scale laboratory studies when required.
· Generate scientific reports/publications and participate in scientific meetings.
· Provide technical input to process validation plans, protocols and reports.
· Skilled in applying design of experiments principles to screening and process characterization studies.
· Help define strategic projects and technology platforms to invest in for continuous improvement of manufacturing operations and lead the project implementation.
· As the technical SME provide technical expertise and discussion during GMP audits from regulatory authorities
· Provide technical input and review of regulatory submissions
· Interface with Manufacturing, Quality and Validation, Quality Control, Process Sciences and Engineering.
· Adhere to all site safety, environmental and industrial hygiene procedures and practices, and actively participate in maintaining and enhancing the safety of the workplace and the laboratories.
· May be required to work periodically out of normal business hours.
· Bachelor’s degree in biochemistry, biology, biochemical engineering or related field with 6+ years relevant experience; Master’s degree with 4+ years; PhD with 2+ years
· Bachelor’s degree in biochemistry, biology, biochemical/process engineering or related field with 6+ years relevant experience; Master’s degree with 4+ years; PhD with 2+ years
· Detailed knowledge in cell culture and/or protein purification science and technology.
· Experienced in the operation and analysis of cell culture and/or protein purification technologies including Seed Train, Aseptic Technique, Fed batch/Perfusion Bioreactors, Chromatography, Ultrafiltration/Diafiltration and Filtration technologies.
· Experienced in cGMP and large-scale manufacturing equipment and practices and with the transfer of technology to cGMP operations.
· Demonstrated knowledge in the scale up considerations of cell culture and/or protein purification processes from lab to plant.
· Understanding of statistical data analysis and a willingness to explore advanced statistical modelling tools.
· Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment.
· Demonstrated skill in leading project teams tasked with resolving complex production related issues.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.
The role of MSAT is to provide excellent scientific and process engineering support to BioMarin’s portfolio of commercial and clinical products. In that regard the work environment is highly varied depending on the support required at any one time. This role will involve both laboratory work and manufacturing support activities using chemicals, laboratory and manufacturing equipment and instruments. Both laboratory & plant scale equipment will have mechanical moving parts. Noise and vibration may be present.
Periodic week-end support work and/or on-call support for Manufacturing will be required.
Describe any equipment required to perform the job.
· Equipment related to bench scale, pilot scale and commercial manufacturing scale cell culture and/or purification technologies, as well as analytical instruments typical in biopharmaceutical labs and manufacturing.
List the key positions, internal and external, with which the job incumbent must interact.
· Quality and Validation
· Process Development
· Quality Control
· Facilities Services
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.
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.