ROLE

The Technical Manager  is responsible for generating stability protocols, internal product health reports, Health Agency annual reports, and product specific stability master plans.   The individual is responsible for coordinating or undertaking statistical analysis of data to support generation of process trends and control limits. The individual prepares trend graphs and analyses, and compiles results into technical documents intended for internal use and direct submission to involved regulatory agencies.

The scope of the position covers both clinical and commercial programs across multiple therapeutic platforms. The individual is responsible for ensuring that functional objectives are aligned with company goals and multi-national regulations. The individual interfaces with QC Product Coordination, QC testing groups (QC Product, QC Analytical, QC In-process, both Novato and Shanbally locations), Analytical Sciences, Process Development, MSAT, QA, Quality Partner Teams, and Regulatory Affairs to ensure accurate, comprehensive, and timely completion of documentation.

The position requires practical knowledge and use of LIMS and Trackwise ( Deviations, CAPAs, LIRs, Change Requests). The individual possesses or can rapidly develop skills in data trending software (JMP, Discoverant) and Statistical Process Control (SPC) charts. Strong interpersonal skills are required to interact with multiple cross-disciplinary departments and effectively function as a member of teams. The individual performs duties with a high degree of independence and minimal supervision.

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 individuals 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.

KEY RESPONSIBILITIES

• Prepares technical documentation intended for internal use and for direct submission to
• involved regulatory agencies
• Prepares stability master plans for all clinical and commercial products, including transitional stability comparability studies for manufacturing process changes and product lifecycle management
• Serves as liaison with Quality Partner Teams on topics of Stability and Reference Materials
• Prepares Annual Product Review Reports for submission to regulatory agencies to meet internal GMP product lifecycle commitments
• Initiates and completes Quality System processes in Trackwise
• Directly accesses data from LIMS
• Ability to manage multiple priority tasks for multiple products concurrently, advising management regarding realistic timelines for completion with limited resources.
• Works with ambiguity and complexity to continuously optimize options and solutions
• Undertakes data analysis in data trending software to generate and support conclusions in technical documentation
• Applies sound problem-solving skills to recommend options and implement effective solutions
• Other duties as assigned

Required

• A BA/BS in a physical science with at least 7 years’ relevant experience, in an industrial setting, with demonstrated ability and performance.
• Proficiency in technical writing and preparing technical documentation intended for internal use and direct submission to involved regulatory agencies
• Experience influencing effectively across functions and levels of an organization.

Highly Preferred

• Expertise with JMP software
• Experience with LIMS and Discoverant
• Relevant experience in a matrix organization is desirable