Job Description

BUSINESS: Piramal Pharma Solutions

DEPARTMENT: Manufacturing

LOCATION: Grangemouth

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Responsible for the technology transfer of both new and repeat Antibody Drug Conjugate (ADC) processes from Process Development to Manufacturing in compliance with Good Manufacturing Practices (GMP), including generation of all required process and technical documentation. Work compliantly within Piramal Quality Management System (QMS) to ensure processes meet company and regulatory requirements. Lead and manage implementation of improvement actions identified through CAPA actions and end of campaign lessons learned.

Reporting Structure:-

Reports to Deputy Head of MSAT

Key Roles/Responsibilities:

• Prepare GMP batch records for use in GMP manufacturing processes.
• Review, approve, and issue manufacturing documentation.
• Determine scale-up criteria from development to manufacturing scale.
• Generate process mass balances and flow diagrams.
• Identify, design and define large scale manufacturing equipment.
• Define materials for use in a GMP manufacturing environment
• Generate quality documentation for raw materials and equipment.
• Work within the Piramal quality system to initiate, manage and evaluate requests for change.
• Perform investigations, close CAPA’s and deviations.
• Project manage all aspects of the introduction of processes to manufacturing.
• Perform risk assessments in alignment with ICH 9Q.
• Evaluate process materials for suitability for use in manufacturing.

Competencies:

• Good time organisation skills
• Strong team working ability
• Good communication skills
• High level of attention to detail
• Good problem solving skills
• Good decision making skills

Essential Qualifications

Preferably BSc (Hons) in Science or Engineering discipline (or equivalent) required.

Essential Experience

• Proven GMP Biologics manufacturing or process development experience
• Strong planning and organization skills to influence and gain support from key stakeholders that collaborate to deliver technical transfer projects
• Strong project management skills
• Process scale-up, transfer and manufacturing support
• A proven track record to meet project deadlines
• Ability to communicate with vast cross sections of people at all levels of the business
• Evaluation of materials for process suitability
• Writing GMP batch records

Desirable Experience:

• Commercialization of biological medicines and process validation
• Experience of process improvement and process mapping
• Definition, sourcing, and validation of large-scale process equipment

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.