Senior Manager Project Management

JOB DETAILS

Position Title: Senior Manager Project Management

Job Purpose

The Senior Pharmaceutical Project Manager will lead end-to-end project management across Oral Solid Dosage Forms (OSD) and Injectable formulations, driving programs from development through regulatory filing and commercial launch. The role requires strong technical expertise, cross-functional leadership, and the ability to manage

external partners (CMOs/CDMOs/CROs) while ensuring compliance with global regulatory standards (USFDA, EMA).

Key Accountabilities

• Lead and manage development projects for OSD and Injectable products from R&D through scaleup, validation, filing, approval, and commercialization.
• Act as the central communication point between CFTs including R&D, Regulatory Affairs, Quality, Manufacturing, Supply Chain, Procurement, Medical Affairs and Commercial teams.
• Coordinate with CMOs, CDMOs, and CROs for technology transfer, site qualification, new product development, and regulatory submissions for US, EU and other EM markets.
• Manage timelines, risk registers, resource planning, and cost controls across all assigned projects.
• Support Capex and Opex planning for new equipment, process scaleup, and new manufacturing site readiness.
• Lead equipment qualification activities and documentation including IQ/OQ/PQ and FAT/SAT coordination.
• Monitor project profitability, ensure alignment with business objectives, and support site addition activities for market expansion.
• Oversee preparation, review, and alignment of technical documents including PDRs, AMVs, validation protocols, batch records, and regulatory filing modules.
• Ensure project compliance with cGMP, ICH, USFDA, and EMA requirements.
• Present project status to senior management with clarity on risks, mitigations, and critical deliverables

  .

Manufacturing Plant Operations & New Facility Setup

• Lead crossfunctional coordination for new facility setup including facility design alignment with GMP and process requirements.
• Coordinate closely with R&D, Engineering, and Manufacturing teams to translate development processes into commercialready operations.
• Oversee endtoend equipment lifecycle including URS creation, vendor evaluation, FAT/SAT execution, installation, commissioning, and qualification (IQ/OQ/PQ).
• Ensure manufacturing readiness by facilitating alignment between R&D process

understanding and plant capability, including process flow mapping and scaleup

strategy.

• Work with Engineering and Validation teams to ensure timely completion of validation master plans, process validation, cleaning validation, and HVAC/utility qualification.
• Support facility audits, regulatory inspections, and documentation readiness for new site approvals or capacity expansion.
• Direct communication with manufacturing project coordinators to track progress, resolve GMP gaps, and ensure realtime project status updates.
• Monitor GMP compliance during buildout phases and ensure seamless transition to commercial operations.

Skills & Capabilities

Core Competencies

• Leadership
• Excellent Communication and Stakeholder Management Skills
• Proven ability to manage multiple complex projects simultaneously.
• Commercial Acumen
• High Level of Accountability and attention to details
• Strong ethical values and commitment to compliance, integrity

Functional Competencies

• Strong Project Management Skillsets
• Operations Management
• Strong Technical Expertise
• Quality System Management
• Well versed with Regulatory Requirements

Educational and Experience Requirements

Minimum Education Requirement

• Masters degree in Pharmacy, Pharmaceutical Sciences, Life

Sciences, Chemical Engineering, or related field.

Experience

• 8 to 12+ years of experience in pharmaceutical product

development, project management, technical operations, or

plant project execution.

• Prior experience managing CMOs/CDMOs/CROs and global

regulatory submissions.

shikha.mishra@walterbushnell.com