Product Operations Lead Biologics

Shire Pharmaceuticals - Lexington, MA (30+ days ago)3.6


Primary Duties

Single point of contact for the Portfolio/Product Teams representing all of Technical Operations. Establishes product strategies based on Business needs and the life cycle of product(s) for both commercial products and product during development (Phase IIb- Phase III) across R&D.

Establishes a Technical Operations Product Team to ensure alignment across Technical Operations and the rest of Shire to establish operations strategies and plans for PONE and for the Portfolio/Product Teams which are related to assigned product(s) and its process(es).

Responsible for developping product priorities in alignment with the business requirements and ensures execution and implementation. Also, ensures that the strategies are executed effectively and in a timely manner - developing project business cases, ensuring performance of project teams to deliver strategic and tactical outcomes.

Interacts with a broad range of internal and external contacts to collect, analyze and recommend solutions to complex challenges. Responsible for ensuring long-term quality and delivery of the assigned product globally and for ongoing continuous improvement of product reliability and cost.

Responsibilities

30%: Participates as a member of and with appropriate Governance Teams in Pharmaceutical Development & Technical Operations to manage product(s) project portfolio, for status check-in and for future support requirement understandings of development products within the pipeline portfolio.

Establishes Technical Operations Product Teams to ensure alignment across Technical Operations and the rest of Shire to establish operations strategies and plans for PONE and for the Portfolio/Product Teams. Responsible for developping product priorities in alignement with the business requirements and ensures execution and implementation.

Develops full and robust business cases based product strategy imperatives to the governance body for approval.

Monitors performance of all process related to assigned product(s), including production, product development, launch preparation, problem resolution and lessons learned. Elaborates imperatives which continually improve product, process and supply chain architecture strategies. Reviews and is accountable for product cost drivers, overall cost of ownership and risk management and ongoing cost improvement – identify cost reduction opportunities – for assigned product(s); makes decisions regarding assets and liabilities related to assigned product(s).

For development products, gains early knowledge and provides support mission and vision of preferred Supply Chain architecture :

Researches and designs recommendations which improve product, process and supply chain architecture strategies and establishes key product launch considerations, attributes and profiles for those product nearing commercialization.
Identifies potential product cost drivers and correlates with Tech Ops budget items for all Operating Units.
Seeks to minimize need for tech transfers and ensure robust commercial process capabilities across Tech Ops and R&D
Supports and guides efforts to advance product knowledge for validation and submission readiness to facilitate ease of commercialization and robust “easy to run” commercial manufacturing processes.
Ensures supply chain activities (commercial supplier capabilities assessments, selections of commercial manufacturers, tech transfers) are executed in a timely and effective manner in order to coordinate with engineering, registration, and submission activities and to enable supply chain readiness plans.
Ensure necessary TechOps support of DP & DS manufacture for clinical studies
20%: Develops and presents robust and effective product strategies & lifecycle plans for Tech Ops related to Commercial and Development Products in Phase IIb and Phase III that establish strategic imperatives which deliver growth for the product(s). Works hand in hand with Marketing, Regulatory Affairs, Legal and Finance departments notably to ensure Operations strategies are complimentary & aligned with the Portfolio/Product Teams and Brand ones.

20%: Establishes strong partnership and working relationships with dCMC teams, cCMC teams, R&D and Portfolio/Product Team Leads.

Represents Technical Operations and PO≠ as single point of contact to Portfolio/Product Team(s). Participates in Product Team’s forums for the Business.

Voting member of the Portfolio/Product Team(s) to make strategic decision for the brand and business.

Establishes solid work and partnering relationships with Portfolio/Product Team Leads, Commercial, Business Development and R&D as well as external suppliers and customers
Objectively challenges the Business to assure Technical Operations point of view are reflected in decisions.
Helps refine decisions, challenge status quo with data definition, metrics backup and sound justifications.
Partners with and gains alliance with various leaders in Technical Operations such that one voice / strategy is reflected to the Portfolio/Product Team customer.
10%: Participates and drives E2E risk assessments aimed at early identification of potential challenges and develops appropriately timed mitigations that fall within Tech Ops remit.

10%: Leads large scale imperatives/programs beyond assigned products that result in positive change in how business is managed in central functions within Technical Operations.

10%: Provides support to the PO≠ teams and Supply Chain where necessary e.g. budget, long range plans, financial modeling for project justifications, due diligence activities, etc.

Education and Experience Requirements

Bachelor’s Degree required, preferably in a life science field. Advanced degree preferred.
Minimum of 10 years industry work experience with experience in pharmaceutical development, and/or supply chain management required.
Experience in problem solving, negotiations, presentation, project management, and collaborative team-building with non-direct reports. (matrix environment)
Demonstrated financial and business leadership understanding.
Other Job Requirements

Up to 20% Domestic and International travel required.