Technical Manager/ Senior Technical Manager - MSAT (OSD)
Technical Manager/Senior Technical Manager, MSAT (OSD), Global External Operations,
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.
The Technical Manager is responsible for the technical support of small molecule drug products from contract manufacturing organizations (CMO) by management of the technical relationship, technology transfers, project management and product lifecycle management.
This position provides strong scientific leadership for all aspects of technology transfer, process monitoring, and process troubleshooting for Oral Solid Dosage (OSD) manufacturing activities at CMO’s. Key deliverables will drive problem solving, shareholder management, process optimization and improvement.
Act as subject matter expert for Oral Solid Dosage (OSD) processes, including technology transfer, process evaluation, problem solving and investigation.
Provide expertise in trouble shooting activities to support manufacturing either on site or virtually.
Analyze data, evaluate results and form conclusions on data provided by the Contract Manufacturing Operation (CMO) to support manufacturing or solve manufacturing issues.
Plan and manage day-to-day technical support work to meet CMO schedules while supporting a high level of GMP compliance at the CMOs through your role on the Joint CMO Operations (JCMO) Team.
Coordinate BioMarin activities in the evaluation of process changes, change requests and deviations to ensure timely resolution.
Attend CMO’s, as necessary, to monitor production campaigns and develop an in-depth knowledge of the manufacturing process and systems at the CMO.
Identify and lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
Proactively monitor process capability for key processes executed at our CMOs and implement relevant process robustness efforts to improve process capability
Provide guidance to process validation program for OSD manufacturing processes at CMOs.
Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
Coordinate and manage projects with cross-functional teams including Process Development, Operations, Regulatory Affairs and Quality.
Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities.
Contribute to the development of formal systems and procedures for the selection of CMOs
Bachelor’s degree or higher in Science or Engineering is a requisite.
A minimum of 8 years’ experience in the pharmaceutical industry with a strong technical services/MSAT experience.
Working knowledge of solid oral dosage manufacturing to enable problem solving and identification of process improvements.
Working knowledge of pharmaceutical regulatory requirements appropriate to level and solid cGMP skills required.
Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long-term goals.
Demonstrated ability to project manage technology transfer and/or new product launches.
Use of Lean Six Sigma tools in continuous improvement projects.
Excellent organizational, written and verbal communication & negotiation skills.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Travel: 20% - 40%
This would arise from time spent primarily at European CMO sites, other travel would include the BioMarin facilities in California, US and Shanbally, Co. Cork.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Internally this person will interact with Process Sciences, Manufacturing, Quality Assurance, Quality Control, Validation, Supply Chain, Finance, Compliance, Legal, Clinical Operations and Regulatory. He/she will also be one of the main contacts for all CMO (Contract Manufacturing Organizations) technical work. He/she will be responsible for optimizing the inclusion and contributions from the Contract Manufacturing Staff, Process Development, Quality and CMO staffs.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.