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Head, Drug Product Development, PRT (Director)

Shire


Location:
Lexington, Massachusetts 02421
Date:
09/25/2017
2017-09-252017-10-25
Job Type:
Employee
Job Status:
Full Time
Shire
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Job Details

The candidate will lead a group of ~6-9 scientists, engineers, development specialists and contractors that will be accountable in the pharmaceutical development of Shire’s pipeline products with a focus on development activities for biologics drug substance and drug product formulation development for Shire’s protein replacement therapies.  Provide technical leadership in formulation development to support pre-clinical and clinical programs at all development stages, drug product process development and drug product process characterization. The candidate will have accountability for the DS and DP formulation and process development for multiple Shire clinical development programs (3 or more programs).

 

The candidate will participate in cross-functional project teams. She/he will author and/or review protocols, technical reports, articles and portions of regulatory submissions to support clinical development and licensure.  The candidate will work closely with groups in Process Development, Research and Non-clinical, Quality, Regulatory, Clinical and Commercial to ensure timely execution DS and DP development to support overall program timelines.  The qualified candidate must be able to effectively partner with diverse team members from various functions, and members at various levels in the organization. The candidate will be expected to effectively work with the device development group and clinical DP process engineering group.  The candidate will lead the departmental efforts to explore and establish modality-based formulation platform, development toolsets, QbD- and QTPP-driven DS and DP development and high productivity technologies, e.g., automation and high throughput approaches, to enhance development efficiency.

 

Responsibilities

     ~50% : Lead a group accountable for the drug substance and drug product formulation and process development for Shire biologics pipeline products in clinical development as protein replacement therapies

     ~20% : Provide technical leadership role for internal functions and outside testing partners and lead the execution of biopharmaceutical development. Provide development strategies and technical guidance for robust formulation and drug product development to support pipeline products with commercially attractive and competitive product presentations.

     ~20% : Develop corporate procedures and policies for combination product pharmaceutical development. Lead the R&D efforts to explore and establish robust pharmaceutical development package for combination products (e.g., in use compatibility, ISO biocompatibility, device E&L study, etc).

     ~10% : Partner effectively with Technical Operations customers to assist in the support of clinical and/or marketed products as needed.  Provide support for regulatory observation remediation and lead initiatives focused on enhanced compliance.  Support manufacturing quality systems as needed to ensure continuous commercial and clinical supply.

 

Requirements

Education and Experience Requirements

  • Minimum of a PhD in Chemistry, Biochemistry, Pharmaceutics, Chemical Engineering or related field with a minimum of 10 years of experience in a biopharmaceutical company and at least 5 years of experience in protein therapeutics.  Experience with enzyme therapeutics and combination product development for biologics is highly preferred.
  • Comprehensive knowledge of biopharmaceutical development process on key milestones and deliverable at all development stage, with extensive experiences on regulatory expectations, industry standardization, and quality management system.  Broad knowledge and working experiences of QbD principles in formulation and drug product development and production for biologics.
  • Strong technical expertise in formulation development, drug product development, production process development and characterization, in-use and clinical support, and related investigations.
  • Strong technical background and extensive experiences for injectable combination product development such as drug product and device compatibility and stability, device functionality and human factor requirements.
  • Demonstrated technical project management and/or project leadership experience to develop integrated short term and long term project plans.
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