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 are a pharmaceutical company with a clear Purpose : to improve lives through innovative and sustainable manufacturing of 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 Rijswijk (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 FDF department has a vacancy in its Barcelona offices, for the following position: Manufacturing Science Technology & Project Manager, ESO The Position MST & Project Manager, ESO Owns technical stewardship of FDF products (E2E oversight of manufacturing process & 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.
Owns & leads technology transfers as part of network optimization/portfolio expansion plans and responsible for project team.
The main activities and responsibilities General: Represent the technology function in ESO with coordination across Centrient and 3rd 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 product, process & 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, specification & technology, related to Regulatory maintenance/new filings, Quality action points/troubleshooting and root-cause/CAPA of production issues.
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, AMT, 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.
Shared responsibility in cross-functional Teams within ESO & FDF organization.
Give Technology support to own FDF Development Team and other disciplines, company-wide within Centrient.
General compliance with Centrient.
Being responsible for budget/cost, timeline, and risk management of assigned technical projects.
Passion for success and driving results.
Improve, Innovate and Change.
Flexible, agile, proactive with a "never give up" type of mindset.
Customer and external focus.
Structured, Analytical, Creative.
Collaborating cross-functional, both internally and with 3rd parties, Engage People.
Qualifications At least 10 years of experience in Pharmaceutical Technology, preferably in generics.
Academic degree (MSc) in Technology, Pharmacy, Biochemistry or related field.
Advanced degree preferred.
Broad, multidisciplinary experience.
Well-trained in all relevant Quality and SHE policies and procedures.
Managerial and social knowledge and experience.
Having extensive experience in pharmaceutical production (Test to Pilot to Full-scale).
Having experience in analytical chemistry.
Having extensive experience in collaborations with (international) third parties.
Having experience in bringing generics to the Market.
Customer and external focus.
Drive for results.
Improve, Innovate and Change.
Engage People.
Act Responsibly.
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 Reference check procedures are part of the Centrient Recruitment & Selection Process.
You will be contacted when a reference check is required.
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