Senior Manager - Manufacturing Sciences and Technology

At Proclinical, we are seeking an experienced and charismatic individual to fill the role of Senior Manager/Associate Director of Manufacturing Sciences and Technology, based in Rockville, MD. The successful individual will advise peers on manufacturing-related issues, initiatives and strategy for continuous improvement of site manufacturing performance and culture.

Responsibilities

• Lead investigations of deviations and develop and implement corrective actions at cGMP manufacturing facilities to enable department(s) to effectively deliver on all commitments.
• Perform detailed data analyses and root cause analyses to identify solutions to complex problems.
• Champions and implements change controls, leads selection of new equipment and materials, and manages their implementation at manufacturing facilities to improve existing and new processes.
• Lead technology transfer activities to internal and external manufacturing sites and corporate partners and serves as technical expert in supporting manufacturing at CMOs.
• Engage with program managers to ensure projects are planned and executed appropriately to deliver to and meet the needs of our customers and the business.
• Contribute to the department's annual budget and quarterly forecasting processes.
• Identify and communicate risk in area of responsibility and across the site.
• Drive compliance with regulatory and quality requirements.
• Review and contribute to regulatory filings for products manufactured at CMOs and attend regulatory meetings as the functional owner.
• Implement continuous improvement and operational excellence methods and tools.
• Delivers process control management and statistical controls throughout the manufacturing operations and work with appropriate continuous improvement tools.

Skills And Qualifications

• BA in related field and 7+ years of relevant experience as well as 3+ years of management experience.
• Experience with commercial scale manufacturing support for mammalian cell culture, aseptic final product filling/kitting/labeling, liquid media manufacturing and/or analytical reagent manufacture, current Good Manufacturing Practices
• Experience authoring and reviewing relevant controlled documents.
• Knowledge of large scale biologic, pharmaceutical manufacturing, current Good Manufacturing Practices and US/EU regulations and intermediate knowledge of statistical data analysis.
• Excellent written, verbal, and interpersonal communication skills.
• Strong knowledge of Microsoft Office suite, especially Excel.

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.