Associate Director - Manufacturing Sciences and Technology

At Proclinical, we are seeking an individual to fill the role of Associate Director of Manufacturing Sciences and Technology, based in Rockville, MD. The successful candidate will advise on manufacturing-related issues, initiatives and strategy for continuous improvement of site manufacturing performance and culture. This role will also represent the MSAT organization during customer/manufacturing network meetings, audits, and regulatory inspections.

Responsibilities

• Lead investigations of deviations and develops and implements corrective actions at cGMP manufacturing facilities to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
• Perform detailed data analyses and root cause analyses to identify solutions to complex problems and monitor and control process performance.
• Lead selection of new equipment and materials and manage their implementation.
• Lead technology transfer activities to internal and external manufacturing sites and corporate partners.
• Engage with program managers to ensure projects are planned and executed appropriately.
• Provide input to technical development early in the process to ensure facility/operational considerations are factored into process decisions.
• Contribute to the department's annual budget and quarterly forecasting processes.
• Manage headcount and expenses.
• Create strategies and plans to manage risk to operations.
• Review and contribute to regulatory filings for products manufactured at CMOs and attend pertinent regulatory meetings as the functional owner.
• Deliver process control management and statistical controls throughout the manufacturing operations and work with appropriate continuous improvement tools.
• Engage in identification, sharing and adaptation of best practices.

Skills And Qualifications

• BA in related field and 9+ years of relevant experience, as well as 4+ years of direct management skills.
• Experience authoring and reviewing technical reports, standard operating procedures, on-the-job-trainings, and other controlled documents.
• In depth knowledge of large scale biologic, pharmaceutical manufacturing, current Good Manufacturing Practices and US/EU regulations and intermediate knowledge of statistical data analysis.
• Ability to set vision and direction for a team including setting expectations and accountability.
• Ability to collaborate with cross functional teams resulting in creative and positive outcomes.
• Excellent written, verbal, and interpersonal communication skills.
• Excellent knowledge of Microsoft Office suite, especially Excel.
• Extensive training in multiple areas of Operational excellence, lean manufacturing, 6 Sigma, etc.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Goldberg at (+1) 2674056995 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.