Manufacturing, Science & Technology Project Manager

Centrient Pharmaceuticals is the 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 stand proudly at the centre 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 2200 employees work continuously to meet our customers’ needs. We work 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 Technical Operations department has a vacancy in its team for the following position:

MS&T Project Manager ESO

The Position

The MS&T Project Manager ESO will own the technical stewardship of FDF products (End-to-End oversight of manufacturing processes, analytical science & technology, specifications, validation & continuous improvement), support regulatory with filing/maintenance questions, QA support with troubleshooting customer/supplier matters all in coordination with CDMO/CRO’s and other Centrient departments. Will own & lead the technology, analytical method transfers as part of network optimization/portfolio expansion plans and will be responsible for project team.

The main activities and responsibilities

General:

• Represent the technology function in ESO with coordination across Centrient and third parties.
• Build and maintain an adequate external network to deliver on customer commitments and long-term growth plans.
• Acts as SPoC & SME across Centrient on all products, process, analytical methods  & technology related matters in compliance with industry regulatory/quality guidelines.

Operational:

• Accountable for ensuring the portfolio is maintained in a validated/compliant status across the product lifecycle.
• Develops portfolio risk assessment and implements annual continuous improvement plans for marketed portfolio.
• Technical coordination/support with CDMO/CRO & Centrient departments across product, process, methods, specification & technology, related to Regulatory maintenance/new filings, Quality action points/troubleshooting and root-cause/CAPA of production, analysis (QC) issues including method improvements.

Tech transfer & network due- diligence:

• Project lead for assigned dossier/tech transfers across FDF manufacturing network.
• Accountable for delivering against business case mandate across the entire project scope (e.g. technical protocol development, method transfers, engineering batches, scale-up/validation & dossier submission).
• Responsible for coordinating a cross-functional project team, their deliverables and reporting status through governance.
• Responsible for providing technical due-diligence support on portfolio/asset acquisitions and evaluation of new to network CRO/CDMO’s

The Ideal Candidate

• University degree in Technology, Pharmacy, Biochemistry or other related studies. Master's degree preferred.
• At least 10 years’ experience in pharmaceutical technology, analytical sciences preferably in generics.
• Extensive experience in pharmaceutical production (Test to Pilot to Full-scale).
• Experience in analytical chemistry.
• Extensive experience in collaborations with (international) third parties.
• Experience in bringing generics to the Market.
• Trained in all relevant Quality and SHE policies and procedures.
• Fluent proficiency in English language (written and spoken).

• Strong communication and influencing skills.
• Customer oriented.
• Results oriented
• Improve, Innovate and Change mindset.
• Managerial and social knowledge experience.

Terms and reward

We offer a local contract in a challenging, comprehensive, operational environment, with many opportunities for personal input and growth and plenty of discussions with other professionals. The organization is very flat. You have 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 also 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 you can contact us via [email protected] We invite you to visit our website www.centrient.com for information about our company.

Reference check procedures are part of the Centrient Recruitment & Selection Process. You will be contacted when a reference check is required.