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Assoc. Dir., Technical Project Management

2+ years
$139,600.00 - $219,700.00
10 March 31, 2025
Job Description
Job Type: Full Time Education: B.S./M.S./Ph.D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director, dCMC Site Implementation

Job Overview:
The Associate Director, dCMC Site Implementation Lead, will be responsible for implementing improved business processes and driving the tactical deployment of digital solutions across company sites. Under the broad guidance of dCMC leadership, the incumbent will develop project plans, manage stakeholders, and oversee resource allocation to ensure the successful adoption of digital solutions.

Key Responsibilities:

  • Project Management: Develop comprehensive project plans for site-specific implementation of digital solutions, including defining scope, objectives, timelines, milestones, and resource allocation.

  • Stakeholder Management & Communication: Identify and engage key cross-functional partners and stakeholders to ensure that project execution meets business needs. Facilitate regular project team meetings and workshops.

  • Cross-Functional Team Leadership: Lead the cross-functional project team and foster a collaborative environment to ensure successful implementation of digital solutions.

  • Resource Management: Collaborate with site teams to identify and manage project resources, ensuring timely completion and budget adherence. Escalate risks and issues as necessary.

  • Implementation Oversight: Oversee the execution of deliverables related to digital solutions, ensuring compliance with operational and quality requirements. Manage the deployment of training for site teams.

  • Risk Management & Issue Resolution: Proactively identify risks, develop mitigation strategies, and escalate issues when necessary. Facilitate problem-solving and resolution.

  • Operating Model Improvement: Contribute to the development and improvement of standard work, knowledge management playbooks, and project management tools to enhance the deployment of digital solutions across the network.

Required Skills and Experience:

  • Knowledge of manufacturing, testing, quality, and supply processes from late clinical development through commercialization.

  • Experience in drug development or manufacturing, including process/analytical development, tech transfer, and validation/PPQ.

  • Familiarity with data sources and IT systems such as LIMS, Signals, MES, DeltaV, and SAP.

  • Strong project management skills with experience managing cross-functional project plans.

  • Effective facilitation, communication, and leadership skills with the ability to influence stakeholders and manage conflict.

  • Demonstrated stakeholder management and ability to lead across functions and divisions.

  • Highly organized with the ability to prioritize activities across teams.

Preferred Skills and Experience:

  • Technical operations experience in drug substance or drug product manufacturing.

  • Automation experience or knowledge.

Minimum Education/Experience Requirement:

  • B.S. in chemistry, engineering, or related field with 8+ years of pharmaceutical industry experience.

  • M.S. in chemistry, engineering, or related field with 6+ years of pharmaceutical industry experience.

  • Ph.D. in chemistry, engineering, or related field with 3+ years of pharmaceutical industry experience.

Job Details:

  • Employee Status: Regular

  • Relocation: No

  • VISA Sponsorship: No

  • Travel Requirements: 10%

  • Work Arrangement: Hybrid

  • Shift: 1st - Day

  • Valid Driving License: No

Posting End Date: 04/03/2025
Requisition ID: R340785