Shire Head, Drug Product Development, PRT (Director) in Lexington, Massachusetts

Primary Duties

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.

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.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.