Associate Director Engineering

MSD; Pune District; Hybrid; INR 1,800,000 - 2,800,000; Full time

Job summary

Merck & Co., Inc. is seeking an experienced professional to ensure pharma process technology projects follow a consistent global AH Quality strategy and regulatory requirements.

The role focuses on product qualifications, technology transfer, process improvement, and validation across external manufacturing sites. The ideal candidate will lead complex CMO programs, manage lifecycle activities, and facilitate cross-department communication to ensure on-time delivery and product quality for AH

Qualifications

• Minimum Undergraduate degree in Sciences (Engineering, Manufacturing Technology, Pharmaceutical Technology, or Industrial Chemistry preferred).
• At least 10 years of experience in technology or manufacturing position in a Pharmaceutical, Food manufacturing or Fine chemicals producing company or extended academic experience in Pharmaceutical/Chemistry.
• At least 5 years in a regulated pharmaceutical CMO environment.

Responsibilities

• Lead API-related changes and transfers across supply chain and CMOs.
• Oversee process qualification/validation activities and lifecycle management.
• Coordinate knowledge transfers with CMOs and internal stakeholders (Quality, Regulatory, R&D).
• Support investigation teams for major quality issues affecting AH pharma products.
• Perform contract manufacturing site technical assessments and tech transfers.

Skills

Adaptability

API Manufacturing

CMO Management

Data-Driven Decision Making

Life Cycle Planning

Process Improvements

Process Validation

Traceability & Change Control

External Manufacturing

Pharmaceutical Process Development

Education

Undergraduate degree in Sciences

Job description

Summary of Position

This position ensures that pharma process technology projects are carried out with a consistent approach and on a timely basis in line with the Global AH Quality strategy as well as applicable regulatory requirements.

Job Description

This position ensures that pharma process technology projects are carried out with a consistent approach and on a timely basis in line with the Global AH Quality strategy as well as applicable regulatory requirements.

The position holder is responsible for and should have experience in product qualifications and technology transfer, process improvement, and process validation.

The position holder is able to act as a team leader and can be held responsible for the performance and/or start-up of a new and/or difficult process technology assignment.

The manufacturing sites that are supported by the person in this position will include third parties producing AH Pharma products.

The position holder will concentrate his/her activities primarily on the support of Global projects at external manufacturing sites.

Major Assignments

• API-related changes, including supplier and API-process changes
• CMO product transfers, including CMO-CMO, site-CMO and R&D-CMO
• Process Robustness and Product maintenance (e.g. due to regulatory changes)
• life cycle management, technical trouble shooting
• Process and method validation/qualification
• Overarching changes to products or materials
• Stage-gate-process (R&D-to-CMO) for new products (e.g. CMC-section review)
• Transfers
• Change control for drug-products (APIs, excipients, packaging)
• Contract manufacturing site technical assessments
• Qualification/validation approaches
• Support of direct knowledge transfers involving CMOs, support of development of global key technology platforms, technical expertise and its technology network
• Facilitation of communication and interface for manufacturing sites to other global/local departments such as Quality, Supply Chain Management, Regulatory Affairs, Pharma R&D, Global Supplier Management, and CMO Organization
• Support or lead investigation teams established to solve major quality issues occurring with our AH pharma products

Skills

• Minimum Undergraduate degree in Sciences (Engineering, Manufacturing Technology, Pharmaceutical Technology, or Industrial Chemistry preferred).
• At least 10 years of experience in technology or manufacturing position in a Pharmaceutical, Food manufacturing or Fine chemicals producing company or in extended experience in an academic environment of Pharmaceutical/Chemistry departments.
• At least 5-year Experience in a regulated environment in pharmaceutical CMO management.
• Regulatory background requirements or motivated to acquire this quickly.
• Strong knowledge of GMP requirements or motivated to acquire this quickly.
• Experienced in internal business processes and organization.
• Travel requirement willing to travel to the different production locations (up to 40 % of the time)
• Language requirements English (fluent)

Required Skills

• Adaptability
• Adaptability
• API Manufacturing
• Business Process Creation
• Change Controls
• Chemical Engineering
• CMO Management
• Customer-Focused
• Data-Driven Decision Making
• Drug Product Development
• Equipment Qualification
• Estimation and Planning
• External Manufacturing
• Life Cycle Planning
• Manufacturing Quality Control
• Manufacturing Technologies
• Operations Management
• Pharmaceutical Manufacturing
• Pharmaceutical Process Development
• Process Capability Analysis
• Process Control Automation
• Process Design
• Process Implementations
• Process Improvements
• Process Maturity {+ 10 more}

Employee Status

Regular

Flexible Work Arrangements

Hybrid

Requisition ID

R413280

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.