Here at ProClinical, we are seeking an individual for the newly-opened role of Senior Director of Biomanufacturing, based in Fargo, ND. The individual chosen for this role will have key responsibility and oversight for functions of the manufacturing and materials management departments, and is also responsible for the manufacture of research-grade, standards-compliant clinical and commercial products that meet client expectations and are delivered on schedule and budget. This position will directly contribute to the development of business and/or functional strategies, and will manage multiple teams of professionals at the site. The ideal individual will assure that the company stays on schedule, meeting demand/revenue targets, and profitability measures that meet or exceed the goals set by executive management, and will ensure overall quality, compliant, and cost-effective operations.
- Work with Manufacturing Directors to ensure the prioritization of production schedules.
- Oversee manufacturing and materials management investigations, CAPAs, process variances and deviations, and ensure on-time completion of same.
- Maintain smooth workflow between departments.
- Balance manufacturing in-house and through third parties to maintain timelines and maximum efficiency.
- Provide manufacturing updates, support technical discussions or onsite visits.
- Build and maintain bridges between relevant departments to ensure design concepts and specification requirements.
- Participate and/or lead relevant product planning and changes.
- Confer with managers in establishment of shift standards and working schedules.
- Proactively resolve technical or operational issues.
- Analyze costs and provide support for the pricing methodology.
- Identify alternate raw materials with equivalent performance to optimize cost and/or supply efficiency.
- Lead with Process Development in transferring new products/processes.
- Develop, implement and monitor departmental objectives and schedules.
- Assist in the development of validation plans and supervise execution of same.
- Ensure facility is maintained in a constant state of inspection readiness.
- Lead site representation during agency and client inspections. Formulate relevant responses.
- Communicate operational status to senior management regularly.
- All ad-hoc duties as assigned.
Skills And Qualifications
- BA in life science or engineering required, graduate degree preferred.
- Experience producing phase III and/or commercial products is required.
- 15+ years’ relevant experience in manufacturing operations in a biotechnology or pharmaceutical manufacturing organization.
- 7+ years of experience in direct management of manufacturing operations in a biotechnology or pharmaceutical manufacturing organization.
- Comprehensive understanding of cGMPs (minimally FDA and EMA), quality systems and compliance requirements for clinical and commercial pharmaceutical manufacturing.
- Experience working for or with a contract manufacturing organization preferred.
- Experience in new site construction and establishment of new operations organization strongly preferred.
- Experience in root cause investigations and successful implementation of corrective actions and countermeasures
- Experience bringing new products from development to full commercialization.
- Excellent written, verbal, and interpersonal communication skills.
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 Herman Bradford at (+1) 6463671088 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.