Manager, Technical Operations Drug Product ( Hybrid)

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Job Description

Objective

Takeda Vaccines Business Unit Technical Operations is seeking a highly motivated individual for the role of Manager, Process Technology Drug Product. In this role you will provide technical expertise and leadership for the tetravalent Dengue vaccine formulation and fill-finish activities. Supporting our external and internal manufacturing to remain operational, continuously improve, and innovate you will assume broad responsibility for tech transfer, process qualification and validation at drug product manufacturing sites. Process package transfer, at scale studies, PPQ, process monitoring, and continuous process improvements are key focus areas for the role. Highly level of exposure and interaction to other functional areas supporting late-stage development, product life cycle management and commercial operations in a matrix organization is part of the role assignment.

This position is based in India and candidate is expected to be present in person for the Plant activities in Hyderabad.

Key Responsibilities:

• Represent technical operations in cross-functional teams for engineering, qualification and validation of new and existing vaccine manufacturing facilities, processes, technology transfers

• Partner with cross-functional stakeholders (PM, Development, QC, QA, Supply Chain, Regulatory, etc.) to enable tech transfer, startup of new product lines, scale up and PPQ

• Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams

• Conduct technical transfer as well as lifecycle management planning & development from a manufacturing and scientific point of view

• Proactively anticipate, evaluate, and resolve technical challenges, major deviations, root-cause-analysis, corrective action preventive action (CAPA) and support related change control processes with strong focus on quality, risk mitigation and regulatory compliance

• Ensure manufacturing processes, facilities, equipment, raw materials and cleaning methods are qualified and where needed validated and maintained in a state of compliance with all GMP and global health regulations

• Apply risk management principles and methodologies throughout lifecycle management including FMEA, gap analysis, etc.

• Support writing and review of process manufacturing documentation as well as relevant sections for regulatory submissions

• Support process for management of data and analysis of various operational parameters, including Continuous Process Verification (CPV) and Annual Product Review (APR)

• Build partnerships in the areas of engineering and process equipment to drive awareness of new technologies for best-in-class manufacturing operations

• Provide scientific and technical support of commercial manufacturing at partners to support corporate goals for supply strategies

Requirement

• Bachelor degree in life sciences / engineering or in a related area. Advanced degree (MS or PhD) preferred

• Solid experience tech transfer, and/or sustaining cGMP for drug product processes in manufacturing of biopharmaceuticals

• Experience working with vaccines and especially live viruses vaccines is a plus

• Scientific and technical knowledge regarding single use materials, formulation processes, aseptic filling, isolator technology, lyophilization and visual inspection

• A self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of structured product development

• Proven ability to work with efficiency across multiple project teams and business functions in a matrix environment

• Able to lead and manage technical teams, serve as a partner and influence others

• Demonstrated cross-functional team experience 

• Flexibility and the ability to work independently as well as excellent organizational skills

• Demonstrated ability to effectively communicate with his team but also at all levels of the organizations

• Willingness to travel

• Ability to maintain discipline on working time management under a hybrid working arrangement

• Excellent command of English (both written and oral), German language knowledge is a plus

Locations

IND - Andhra Pradesh - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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