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.
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 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
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 Limiteds 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.
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