Associate Director - Drug Product Manufacturing & Development

Role Summary

The Associate Director of Drug Product Manufacturing is accountable for all clinical drug product manufacturing including process characterization activities to support commercialization for nucleic acid programs and will have thorough knowledge of cGMP's for aseptic pharmaceutical products. The position will lead a team of Drug Product Managers, manage CMOs to ensure the continuous supply of product, apply risk mitigation strategies, and perform formulation studies in a laboratory setting as needed. Frequent cross-functional interaction with multiple departments will be required while supporting multiple projects.

Responsibilities

• Lead, manage, and advise all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols, master batch records, regulations, and timelines
• Lead and be an example for a drug product team that is responsible for ensuring clinical supply using aseptic manufacturing
• Identify and work with formulation development CROs to implement new production processes at CMOs and NDA-enabling work. Processes may include but are not limited to formulation, sterilization, filling, and lyophilization
• Responsible for 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, Analytical Development, Materials Management, and Clinical Supply
• Write, review, and/or approve Standard Operating Procedures, specifications, regulatory filings, Master/Executed Batch Records, or other controlled documents as needed
• Responsible for managing timelines, production plans, and material requirements
• Manage DP team resource loading and personnel development
• 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

Qualifications

• Bachelor’s degree with 9+ years of experience, Master’s degree with 7+ years of experience, or PhD with 5+ years of experience in a cGMP setting required. Degree in Biochemistry/Chemistry/Engineering or related discipline required
• In-depth experience in pharmaceutical operations associated with aseptic processing required
• Proven leadership of technical teams required
• Experience working to standards required for regulatory compliance of Aseptic Processing facilities required
• Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities, and associated pharmaceutical processes required
• Experience with the drug product formulation development process and optimization preferred
• Understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems required
• Ability to perform risk assessments required
• Experience in problem solving and continuous improvement techniques required
• Excellent verbal and written communication skills required
• Ability to work effectively managing CMOs required
• Strong planning & organizational skills (and an ability to work to targets, deadlines, and prioritize) required
• Proficient in MS Word, Excel, MS Project & PowerPoint required
• Understanding of national and international regulatory requirements as it relates to Aseptic Manufacturing required
• Proficient in generating and executing protocols and reports required

Education

• Bachelor’s degree in Biochemistry/Chemistry/Engineering or related discipline; advanced degree aligned with role requirements preferred

Additional Requirements

• Physical Requirements: Approximately 15 – 20% overnight travel. Ability to lift 0 – 10lbs.