MSAT Bioprocess Engineer

Piramal Pharma Solutions; Falkirk; On-site; GBP 50,000 - GBP 70,000; Full time

Job summary

A leading pharmaceutical solutions provider in Scotland is seeking an expert to oversee the technology transfer of Antibody Drug Conjugate (ADC) processes into manufacturing. Responsibilities include preparing GMP batch records, reviewing manufacturing documentation, and managing process introductions. Ideal candidates should possess strong organizational skills, attention to detail, and familiarity with GMP practices. This role offers a unique opportunity to contribute to significant advancements in the pharmaceutical industry.

Qualifications

• Experience with GMP manufacturing processes.
• Strong understanding of quality management systems.
• Ability to manage complex process implementations.

Responsibilities

• Prepare GMP batch records for manufacturing processes.
• Review and issue manufacturing documentation.
• Project manage process introduction to manufacturing.

Skills

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

Job description

Job Overview

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.

BUSINESS: Piramal Pharma Solutions
DEPARTMENT: Manufacturing
LOCATION: Grangemouth

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 CAPAs and deviations.
• Project manage all aspects of the introduction of processes to manufacturing.
• Perform risk assessments in alignment with ICH Q9.
• 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

Company Overview

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 Affluent 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 any other 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.

About Piramal Pharma Solutions (PPS)

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.