Centrient Pharmaceuticals is a leading manufacturer of beta-lactam antibiotics, and a provider of next-generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients, and finished dosage forms.
We proudly stand at the center of modern healthcare as a maker of essential and life-saving medicines.
With our commitment to Quality, Reliability, and Sustainability at the heart of everything we do, our over 2,200 employees work continuously to meet our customers' needs. We strive towards a sustainable future by actively participating in the fight against antimicrobial resistance.
Founded 150 years ago as the 'Nederlandsche Gist- en Spiritusfabriek', our company was known as Gist Brocades. Headquartered in Rotterdam (Netherlands), we have production facilities and sales offices in China, India, the Netherlands, Spain, the United States, and Mexico. Centrient Pharmaceuticals is wholly owned by Bain Capital Private Equity, a leading global private investment firm.
The Position
The Global Technology and Transfer Lead drives competitiveness of Centrient manufacturing processes via standardization, technology improvement projects, and assists the sites when trouble-shooting.
This role is responsible for flawless execution of tech transfers activities in line with cGMP and SHE standards when introducing new or improved processes developed by Innovation to commercial manufacturing sites.
As a global expert, they realize EBITDA growth and improved reliability by introducing new and/or improved products and processes.
Main Activities and Responsibilities
The Global Technology and Transfer Lead owns the process knowledge of the product(s) assigned and throughout the commercial lifecycle maintains oversight on process capability:
* Review Technology Development Reports prior to transfer and validation, adapt control strategy if needed.
* Define scale-up, pre-validation/validation strategy.
* Ensure that all relevant technical information and documentation for validation are available.
* Support Site MS&T and Validation Lead/Validation Expert in creation of relevant product documentation (i.e. validation protocol and report).
* Review first APQR after transfer to ensure adequate product performance.
* Manage transfer projects.
Improvement/Major Changes
* Manage process optimization projects.
* Assess impact of major changes, assess their technical feasibility, challenge technical risk, and business benefit of technical changes proposed.
* Collaborate with Continuous Improvement teams for product/process improvements.
* Support trouble-shooting activities.
* Participation in due diligence.
* Development of local teams.
The Ideal Candidate
We are looking for a University degree holder in Science (chemistry, biotechnology, pharmacy, engineering) or other related studies.
The ideal candidate should have at least 10 years' experience in the pharmaceutical industry.
A fluent proficiency in English language (written and spoken) is required.
Experience in Technology Transfer project at highly regulated environments is necessary.
GMP and Compliance knowledge at pharma industry and high-regulated environment is also required.
A good understanding/experience of drug substance manufacturing processes is necessary.
Experience in fermentation processes is an asset.
Project Management skills are necessary.
* Good communication skills are required.
* Experience to work on multicultural environments is necessary.
Terms and Reward
We offer a local contract in a challenging, comprehensive, operational environment with many opportunities for personal input and growth.
The organization is very flat, providing you with a lot of freedom and responsibility in an open, direct, and informal atmosphere.
The Procedure
Please submit your application via the 'apply' button and upload your CV & cover letter in English.
We ask you to include information on your current remuneration.
Only applications with CV and Cover Letter will be considered.
For more detailed information about the role and about the Recruitment & Selection process, please contact us via [website URL].
Reference check procedures are part of the Centrient Recruitment & Selection Process.