Sr. Manager, Pharmaceutical Engineering Zogenix, Inc.
Supervisor: Eric Scharin, Director, Engineering
Department: Operations - Engineering
This employee is responsible for planning and execution of process engineering; equipment specification, procurement, and qualification; and process validation of pharmaceutical manufacturing processes. The employee is also responsible for management of drug product technology transfers (clinical and commercial) and key capital procurement projects throughout the supply chain.
PRIMARY RESPONSIBILITIES & DUTIES
Provide leadership of drug product clinical manufacturing and technology transfer projects at selected CMOs.Develop g general procedures, tech transfer plans, success metrics, and deliverables for DosePro technology transfer projects and pipeline clinical manufacturing projects. Provide project management of assigned Engineering projects.
Prepare project plans (i.e. charter and schedule) to ensure delivery of project objectives on time and within budget.
Track and regularly communicate progress towards project milestones.
Approve budgeted project expenditures in compliance with Zogenix signing authority policy.
Assist in project cost accounting through generation of purchase requisitions and maintenance of cost spreadsheets.
Identify and communicate project risks and opportunities to supervisor, and propose mitigation and capitalization plans.
Generate project change documentation for approval.
Develop and maintain project RACI/Roles and Responsibilities matrices.
Provide Engineering support for Process Engineering.
Generate and/or review process risk assessments and develop risk mitigation plans.
Generate and/or review engineering and qualification protocols to support equipment qualification (including cleaning validation).
Generate documentation for change controls, as required.
Other engineering activities as required to support Zogenix Persons-in-Plant (e.g. quality investigation reports)
Create and update process definition documentation, including (as required) process descriptions, technical specifications, process models / mass balances, and bills of materials.
Generate and/or review Process Validation documentation, including Validation Master Plans, Process Performance Protocols, and change controls for validated processes.
Provide CMC support for drug product filings.
Assist in management of Zogenix Engineering functions.
Support Product Development with the design of pipeline products and processes.
Strong knowledge of aseptic pharmaceutical operations.
Strong knowledge of Good Manufacturing Practice.
Strong knowledge of assembly operations.
Strong knowledge of pharmaceutical equipment / facility design and qualification.
Strong knowledge of pharmaceutical process validation, including cleaning validation.
Strong knowledge of problem solving & root cause analysis methodologies, with proven ability to apply within pharmaceutical operations.
Good understanding of application of statistical techniques for data analysis, process control, and validation. Six Sigma experience (Green or Black Belt) a plus.
Good understanding of Design of Experiments, with proven ability to apply within pharmaceutical operations.
Good understanding of risk management methodologies, with proven ability to apply within pharmaceutical operations.
Management & Leadership Skills:
Strong understanding of project management methodologies, with proven ability to apply within pharmaceutical operations.
Strong written communication skills.
Good presentation skills.
Good facilitation skills.
Basic understanding of managerial accounting
Effective interpersonal skills.
Proven ability to effectively manage interactions with partners, including CMOs, Zogenix Quality, and Zogenix Development.
Actively builds relationships within and across functions.
Results-focused, forward-looking, and solutions-oriented.
Passionate about learning and self- improvement.
Promotes honesty and integrity within Zogenix.
Respectful of colleagues both within and outside Zogenix.
Driven towards superior effort and performance.
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