Associate Director, Pharmaceutical Engineering Zogenix, Inc.
THIS JOB HAS EXPIRED This employee is responsible for direction of process engineering, technology transfers (clinical and commercial), and key capital procurement projects for drug product manufacturing with a focus on aseptic processes.
REPORTS TO: Director, Engineering
LOCATION: Emeryville, CA
CRITICAL SUCCESS FACTORS
Candidate must have a proven track record of managing parenteral drug product technology transfer projects and/or facility start-ups.
Candidate must be an excellent communicator and work well with a broad range of individuals.
Candidate must have a proven track record of solving complex problems.
SCOPE AND RESPONSIBILITIES:
Provide strategic leadership of clinical manufacturing and technology transfer projects.
Define general procedures and deliverables for DosePro technology transfers and manage clinical manufacturing projects
Provide project management of assigned Engineering projects.
Prepare project plans to ensure delivery of project objectives on time and within budget
Assist in project cost accounting
Identify and communicate project risks and opportunities; propose mitigation and capitalization plans.
Generate project change documentation for approval.
Generate engineering, qualification, and validation protocols and documentation for change control in support of Process Engineering.
Create and update process definition documentation, including (as required) process descriptions, technical specifications, process models / mass balances, and bills of materials.
Support Product Development with the design of new products and processes.
Experience & Education:
Minimum M.S. and 5-7 years experience (or BS and 7-10 years) in engineering discipline, or equivalent. Chemical or Mechanical Engineering preferred.
Minimum 5 years experience in pharmaceutical industry with focus on aseptic manufacturing facilities and processes
Experience in manufacture of parenteral injection systems strongly preferred
Knowledge, Skills and Abilities:
Strong knowledge of aseptic pharmaceutical operations, GMP, assembly operations, pharmaceutical equipment / facility design and qualification and pharmaceutical process validation, including cleaning validation.
Strong knowledge of problem solving, root cause analysis and project management 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 and risk management methodologies.
Excellent communication and interpersonal skills.
Proven ability to effectively manage interactions with partners, including CMOs, Zogenix Quality, and Zogenix Development.
Frequent (15-25%) travel required between office base and CMO locations, mostly within Europe.
||Emeryville, CA |
THIS JOB HAS EXPIRED