Senior Manager
3 weeks ago
We are seeking a highly experienced and dynamic professional to manage parenteral drug product manufacturing and corresponding CMC regulatory activities. The ideal candidate will have thorough knowledge of cGMPs for aseptic pharmaceutical products and experience working to standards required for regulatory compliance of Aseptic Processing facilities.
Key Responsibilities- Manage all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols, regulations, and timelines.
- Partner with Chemical development to implement new production processes at CMOs, including formulation, sterilization, filling, and lyophilization.
- Manage key manufacturing metrics / goals, support critical program milestones, and drive continuous improvement initiatives that are essential to meeting patient and business needs.
- Rapidly and accurately communicate issues to Senior Leadership. Resolve manufacturing and facility issues to mitigate any supply disruptions to our patients.
- Work effectively across all departments, such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory, Quality Control, Supply Chain, and Clinical.
- Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, Master/Executed Batch Records, or other controlled documents as needed.
- Manage timelines, production plans, and material requirements.
- Ensure the effective use of material, equipment, and personnel in producing quality products.
- Optimize and investigate formulation, sterilization, and filling processes and parameters through experiments in a laboratory setting.
- BS/MS in Biochemistry/ Chemistry/Engineering or related discipline and 5+ years in a cGMP setting.
- In-depth experience in pharmaceutical operations associated with aseptic processing.
- Experience working to standards required for regulatory compliance of Aseptic Processing facilities.
- Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities, and associated pharmaceutical processes.
- Experience with the drug product formulation process and optimization.
- Understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems.
- Ability to perform risk assessments.
- Experience in problem solving and continuous improvement techniques.
- Excellent verbal and written communication skills.
- Ability to work effectively managing CMOs.
- Strong planning & organizational skills (and an ability to work to targets, deadlines, and prioritize).
- Proficient in MS Word, Excel, MS Project & PowerPoint.
- Understanding of national and international regulatory requirements as it relates to Aseptic Manufacturing.
- Proficient in generating and executing protocols and reports.
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