Pharma Drug Product Technical Services Specialist – External Supply

Cpl in partnership with our Client Pfizer are looking for a

Pharma Drug Product Technical Services Specialist – External Supply area

Provides technical subject matter expertise to Pfizer’s External Supply Operating Unit, contributing directly to the lifecycle management of solid dose and sterile injectable drug products produced by contract manufacturers (CMOs). Manages process optimisation and/or in situ change projects; investigates and resolves product or process failures which impact on product quality.

Participates as the Technical representative in Pfizer’s Virtual Site Operating Teams (VSOTs), providing management oversight of externally manufactured products.

POSITION SUMMARY

The Pfizer Global Technology & Engineering (GTE) Team provides Technical Leadership to Pfizer’s External Supply (ES) Operating Unit. The scope of the current open position includes (a) Drug Product technical investigations, solution development & implementation; (b) technical change management and (c) proactive process optimisation projects resulting in improved product & process performance.

The sites where the products are manufactured are non-Pfizer sites i.e. a 3rd party manufacturing location (CMO).

The Tech Services Specialist or Engineer uses their own expertise as well as leveraging subject matter experts from across Pfizer to develop and deliver effective solutions vs identified challenges; interacts closely with Pfizer Operations, Quality, Supply Chain functions, as well as Regulatory Affairs and the CMOs themselves.

POSITION RESPONSIBILITIES:

• Resolves technical problems effectively and efficiently. Starts with clear and concise problem statements and ends with the planned implementation of clearly defined & effective CAPA. Proficient in DMAIC and other six-sigma methodologies
• Can coach others on problem solving techniques and methods.
• Works independently to meet stakeholder needs and expectations; may involve the leadership of a matrix team.
• Maintains oversight on the budget during the change period; manages project risks i.e. leads the development of risk assessment and mitigations with the project team.
• Leads technical change, from definition of the change, participation in the business case development, through planning, endorsements, execution and closing.
• Uses Pfizer’s established processes for the proactive optimisation of product – process performance (also known as Process Robustness).
• Partners with all other functions responsible for progress of the investigation, change or optimisation project, typically Pfizer Quality, External Supply Operations, Supply Chain, Artwork team, Regulatory, CMO.
• Good communicator who reports clearly on progress and at a frequency required by stakeholders; can clearly articulate obstacles and challenges encountered, requiring wider team or senior management direct support.
• Communication is typically through Pfizer’s VSOT model (Virtual Site Operations Team).
• Specific to longer duration projects e.g. process optimisation or technical change: the establishment and management of routine team meetings to facilitate plan updates, decision-making, problem solving, escalations e.g. resourcing gaps, mitigations vs non-adherence to plan.
•  Takes ownership for administrative activities related to the project such as action/issue item tracking and follow up, generation of project meeting agendas and minutes, coordination and facilitation of focused working sessions involving internal and external team members and stakeholders.

ORGANIZATIONAL RELATIONSHIPS:

ES Operational Managers, Supply Chain, Procurement, QO (ESQuality), Regulatory, GTE SME teams, Global artwork teams.

RESOURCES MANAGED:

None directly, but as technical leader may be accountable for leading a matrix team.

EDUCATION AND EXPERIENCE:

• Minimum of a Degree in a Chemistry, Bioscience or Engineering discipline
• Strong theoretical and practical knowledge of pharmaceutical manufacturing unit processes for both solid dose and sterile injectable dosage forms, with a minimum of 10 years’ experience working directly within Drug Product process development or manufacturing, ideally in a technical support / troubleshooting type role.
• Project management training and minimum 3 years’ experience acting as the leader of matrix teams handling complex technical projects. Ability to demonstrate successful execution of technical change projects on schedule and to budget.
• Experience of working in a third-party manufacturing environment (either as contract giver or acceptor) is beneficial, but not essential
• An understanding of the Pharma regulatory environment, while not essential, would be advantageous.
• Experience of working remotely in a matrixed & virtual environment.

SKILLS & COMPETENCIES:

• Excellent written and verbal communication skills. Ability to articulate a problem and communicate effectively with team members and stakeholders at all levels. Intuitive and focused on achieving results.
• Well-developed interpersonal skills (leadership, communication, integrity, team orientation, flexibility and creativity)
• Project Management capabilities
• Highly structured individual who can work with significant complexity and in the “grey space”.
• Strong knowledge of Pharmaceutical Drug Product manufacturing essential: solid oral dose as well as sterile injectables.
• Self-driven and works independently to achieve milestones & goals.
•  High level of attention of detail
• Seeks help with scope when appropriate.

PHYSICAL POSITION REQUIREMENTS:

The role is primarily office-based and virtual. Not expected to sit at a Pfizer site location. Travel to external meetings and CMOs may be required.

This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent.