Biotech Process Development/Sr. Consultant

BearingPoint, Inc. (NYSE-BE) is one of the world's largest Management and Technology Consulting companies dedicated to aligning business processes and systems to empower Global 2000 companies and government organizations.BearingPoint’s Life Sciences Supply Chain Solution Team is currently seeking a qualified individual to fill an immediate need to provide our existing pharmaceutical clients with leadership, strategy, and business process best practices around process development. This senior consultant/manager role will report to a senior manager in the life sciences group focusing on pilot and manufacturing strategy and implementation. In this role, this sr. consultant would provide subject matter expertise in the business processes and technologies to enable biotechnology organizations from product conception to technology transfer for full scale manufacturing. Knowledge of business process and data modeling, and standardization within the context of product information standards including eCTD, SPL, PIM, and ISA S95 is helpful.
Location/s: Midwest, West
Relocation: No
Performance Profile:

This resource will provide subject matter expertise with design and implementation of best practices around process development. This includes new product introduction, analytical chemistry, pilot manufacturing and technical transfer. This resource should have worked directly or through consulting in product development organizations. (not primary research).

This resource has experience has lean manufacturing and six sigma experience in applying to manufacturing operational excellence. This resource can help establish KPI’s and best practices around the process development. Experience working for biotech clients a must.

This resource will normally be involved from the Strategy phase through implementation and would normally be expected to perform as a senior consultant for implementation business and technical tracks, acts subject matter expert on process development and understanding the integration into other components of the supply chain including research and manufacturing.

During the strategy phase of Process Development engagements, this resource should present ideas, suggestions, recommendations beyond those already in place for implementation technology and integrations to other ERP components such as SAP or Oracle.Position-specific Requirements:
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Technical & functional requirements: Experience working in Biotech organizations with specific process development processes and enabling technologies. Has helped implemented analytical chemistry, new product launch, involved in IND or BLA filings.
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Knowledge around Product Development, Technology Transfer, Product Registration, and CMC component of submissions process.
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Biotechnology product experience such as : Monoclonal Antibodies, Small Molecule, and/or Devices.
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Engineering Degree or Analytical Chemistry degree preferred.
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Minimum years of experience required: 8
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