Job Description

Position Overview

The

Assistant General Manager - Projects (API Pharma)

will be responsible for leading and managing end-to-end project activities for

Greenfield and Brownfield API (Active Pharmaceutical Ingredient)

manufacturing facilities across domestic and international locations. The incumbent will oversee all phases of the project lifecycle--conceptualization, design, engineering, procurement, construction, installation, commissioning, and handover--ensuring timely delivery, adherence to budget, and full compliance with

cGMP

,

EHS

, and

regulatory

standards.


This role requires a highly skilled project management professional with a strong background in pharmaceutical engineering, process design, and cross-functional coordination, capable of managing complex projects while driving excellence in quality, safety, and cost-effectiveness.

Key Responsibilities

1. Project Planning & Execution

Lead

end-to-end project management

for new API manufacturing facilities, plant expansions, and capacity enhancement projects. Develop and manage

project schedules, budgets, timelines, and resource plans

using tools such as

Primavera or MS Project

. Coordinate with

consultants, architects, and EPC contractors

for basic and detailed engineering, procurement, and construction activities. Drive

installation, commissioning, and qualification (IQ/OQ/PQ)

of process, utility, and ancillary systems. Ensure

on-time delivery

of projects within approved budgets and scope.

2. Engineering & Technical Oversight

Review and approve

Process Flow Diagrams (PFDs)

,

Piping & Instrumentation Diagrams (P&IDs)

, equipment data sheets, and layout drawings. Ensure engineering design adheres to

cGMP

,

USFDA

,

EMA

,

MHRA

, and

WHO

standards. Support

technology transfer

,

process scale-up

, and

equipment selection

in coordination with R&D and Manufacturing teams. Provide

technical leadership

in areas such as

utilities (WFI, clean steam, HVAC, chillers, compressed air)

and

cleanroom design

.

3. Cross-Functional Coordination

Collaborate closely with internal teams including

Production, Quality Assurance, Quality Control, Regulatory Affairs, EHS, and Procurement

for smooth execution. Work with

Finance and Procurement

for cost estimation, vendor selection, contract negotiation, and budget tracking. Lead

site-based project teams

, ensuring effective communication, accountability, and goal alignment. Build strong relationships with external partners, consultants, and suppliers to ensure best-in-class project delivery.

4. Compliance, Quality & Safety

Ensure strict adherence to

EHS (Environment, Health & Safety)

and

Quality Management

standards throughout project execution. Conduct

Hazard and Operability Studies (HAZOP)

, risk assessments, and implement mitigation strategies. Ensure all activities comply with

statutory, local, and international regulatory

requirements. Support readiness for

regulatory audits and inspections

related to project and facility setup.

5. Reporting & Documentation

Prepare

comprehensive project reports

, including progress updates, risk analysis, and deviation reports, for senior management. Maintain

accurate documentation

as per GMP and project management protocols. Track project performance against defined

KPIs and milestones

, recommending corrective actions as needed. Present updates in

management review meetings

and provide visibility into project health and financial status.

Qualifications & Experience

Education:

B.E./B.Tech/M.Tech in

Chemical Engineering

Experience:

Minimum

15+ years

of experience in

API or bulk drug project management

, preferably with leading pharmaceutical companies. Proven experience in executing

Greenfield and Brownfield projects

from concept to commissioning. Exposure to

multi-location projects

(India and/or international sites). Strong understanding of

GMP facility design

,

process equipment

,

utilities

, and

HVAC systems

. Familiarity with

international regulatory guidelines

- USFDA, EMA, MHRA, WHO. Proficiency in

project management tools

such as

Primavera, MS Project

, and

AutoCAD

.

Key Competencies & Skills

Strong

leadership and people management

skills; ability to lead cross-functional teams. Excellent

communication, negotiation, and stakeholder management

capabilities. Strategic thinker with a

hands-on execution approach

. Strong

analytical, problem-solving, and decision-making

abilities. Demonstrated ability to

manage budgets, timelines, and multiple priorities

under pressure. Commitment to

quality, safety, and regulatory compliance

. Willingness to

travel extensively

(domestic and international) based on project needs.

Key Performance Indicators (KPIs)

Timely completion of projects within approved budget and scope. Compliance with regulatory, safety, and quality standards. Effective vendor and contractor management. Achievement of project milestones and financial targets. Stakeholder satisfaction and cross-functional collaboration effectiveness.

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.



We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

Piramal Pharma Solutions (PPS)

is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.