Job Purpose:

The Global Technology, Engineering & Launch (GTEL) Small Molecule Technology External Supply Drug Product (SMT ES DP) team provides technical leadership and project / program management to support the reliable supply of small-molecule drug products manufactured by contract manufacturers. The team’s work scope includes Technology Transfers, Material Source Change Qualifications, Complex Investigations, Process Improvements, Technical Risk Assessments and product sourcing assessments.

The Senior Manager GTEL SMT ES DP leads cross-functional teams and works closely with Contract Manufacturing Organisations (CMOs) and Virtual Supply Operating Teams (VSOTs) to deliver projects and resolve technical issues affecting quality, supply, and cost, providing subject-matter expertise, clear stakeholder communication and accountability for key milestones and outcomes.

Job Responsibilities

• Provide technical and project leadership for drug product technology transfers, material source changes and other complex technical change projects, ensuring delivery in accordance with agreed timelines, budgets, business objectives and established processes.
• Lead the full project management cycle, including preparation of project charters and implementation plans, resource and budget forecasting, schedule development and maintenance, project governance, meeting leadership, action tracking, reporting and stakeholder communications.
• Build and lead cross-functional teams involving CMOs, manufacturing sites, Drug Product SMEs, CMC, Quality, EHS, External Supply and other network experts to deliver project milestones and resolve technical challenges.
• Provide timely technical support and leadership for complex CMO investigations involving manufacturing, analytical or product-quality issues; identify root causes, recommend solutions and review appropriate corrective and preventive actions.
• Lead the evaluation, execution and implementation of drug product process and technical changes at CMOs, including ownership of change controls where applicable and engagement of network SMEs as required.
• Serve as a key technical point of contact for assigned Virtual Site Operating Teams, CMOs and internal stakeholders, supporting reliable supply and the resolution of quality, compliance, cost and supply risks.
• Review and if necessary approve, drug product manufacturing documentation, including protocols, batch records, operating instructions, specifications, analytical and manufacturing data, validation documentation and other technical records.
• Author and review technical reports, protocols, risk assessments, change documentation and regulatory submission content related to drug product manufacturing processes and control procedures.
• Plan, coordinate and support process validation, analytical method transfer / validation, scale-up and other qualification activities required for drug product transfers and technical changes.
• Lead continuous improvement and cost-saving initiatives with CMOs and cross-functional teams to improve drug product process capability, yield, quality, supply performance and cost competitiveness.
• Perform technical assessments and due diligence for new business and source change proposals, evaluating technical risks and mitigations, resource and financial requirements and indicative implementation timelines.
• Proactively identify project and technical risks, issues and dependencies; develop and coordinate mitigation or resolution plans and escalate significant concerns appropriately.
• Present project status, technical findings, risks, mitigations and recommendations clearly to senior leadership, external stakeholders and relevant governance forums.
• Manage assigned project budgets and ensure applicable financial, governance and tax requirements are met.

 

Education, Background and / or Experience:

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering or a related science, with 7+ years of pharmaceutical industry experience in drug product manufacturing, technical support, validation or product / process development.
• Wide knowledge and experience of small-molecule non-sterile drug product technologies, manufacturing and primary packaging processes, equipment and control procedures.
• Extensive experience of leading complex technical product lifecycle change projects (e.g. Technology Transfers and material source changes) in the External Supply space.  
• Demonstrated ability to lead cross-functional matrix teams, build constructive relationships with CMOs and internal stakeholders, and deliver project milestones.
• Demonstrated ability to work independently, manage concurrent complex projects across sites and functions, and prioritise competing activities according to business needs.
• Strong analytical and problem-solving skills, including the ability to use Operational Excellence (OpEx) tools such as Six Sigma DMAIC & Process Capability for investigations and continuous improvement activities.
• Excellent verbal, written and interpersonal communication skills, with the ability to tailor messages to different audiences.
• Well-developed interpersonal skills (e.g. leadership / facilitation, teamwork, relationship building, collaboration, influencing, negotiation, conflict management)
• Knowledge and experience of cGMP and Pfizer quality systems.
• Knowledge and experience of pharmaceutical drug product regulatory requirements, with direct experience in supporting CMC with preparation of regulatory submission documentation for post-approval changes to major authorities such as the FDA and EMA.

Desired Experience:

• Experience working in cross-functional and culturally diverse global teams.
• Proficiency with project management and scheduling software, including MS Project.
• Basic knowledge / awareness of typical processes for API manufacturing and control.
• Knowledge of standard drug product process risk management principles and procedures, e.g. FMEA.
• Knowledge of process safety and general EHS requirements.
• Knowledge and experience of niche manufacturing technologies for small molecule drug products, e.g. soft gel capsules, freeze dried tablets, hot melt extrusion.

Travel Requirement

The role may involve some occasional travel.  Travel is typically to internal meetings or to contract manufacturers. 

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Engineering