Technical Launch Integrator Drug Substance Sm
Il y a 7 mois
**At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have sought to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, build healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science, and resourcefulness to profoundly change the trajectory of health for humanity.
Within Manufacturing Science and Technology (MSAT) of Johnson & Johnson Innovative Medicines Supply Chain (Supply Chain), a member of Johnson & Johnson's Family of Companies, we are excited to recruit a **Technical Launch Integrator **(TLI) with the primary location in Belgium.
Would you like to be a part of our team?
The TLI has overall accountability for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes and products into the supply chain and the global marketplace. A main objective of the role is strong collaboration with R&D and the commercial manufacturing sites (internal or external) to ensure a robust product and manufacturing process is developed and successful transferred considering Best Process at Launch (BPAL) principles.
Areas of key responsibility include API technical support and oversight for the supply chain.
As a TLI, you will be a member of the Supply Chain, Value Chain Team (VCT), Site operational teams, and lead the new product introduction team at the sites. You will also be a full member of several R&D teams, CMC Sub teams, and R&D SI (Scientific Integrator) Sub teams, working hand in hand with R&D to successfully develop and transfer to the commercial launch site (internal or external).
The focus of this TLI position is on API and SDP (Spray Drying) within the Small Molecule Platform
**Key Responsibilities**:
- Act as lead MSAT point of contact for Supply Chain ensuring fit for lant and plant readiness for technical transfer to commercial operations.
- Facilitate commercial site technical support during execution of transfer activities.
- Ensure incorporation of Supply Chain technical expertise to include Best-Product-At-Launch and Quality-by-Design principles by providing input from early development through late development, encouraging alignment between Supply Chain and R&D.
- Evaluate thoroughly the BPAL (Best Product & Process at Launch) information
- Support the MSAT Technical Review Process.
- Contribute to, review, and approve regulatory documents for global markets.
- Represent the manufacturing sites on the CMC R&D Sub-team and the VCT.
- Partner with R&D and Supply Chain to identify and implement opportunities for active decrease in COGs and ensure fit for plant and commercial robustness of new products.
- Build value by proposing potential product supply strategies ensuring security of supply, low COGS, tax advantages, while balancing innovation, EHS, QA, compliance, and financial requirements.
- Develop the manufacturing site execution plan per product, in line with the overall strategy as outlined by the R&D, CMC, and Value Chain teams. The TLI will ensure alignment and endorsement of this strategy within the manufacturing sites and TLI function of Supply Chain MSAT.
- Providing required manufacturing site based technical support, technical documentation input, review and approval and serving as the Supply Chain technical product expert.
- Coordinate product introduction at the site from transfer through launch covering raw materials, process, EHS, engineering, packaging, sterilization (if required), and other items needed for a successful technical transfer and launch.
- Delivering clinical through to commercial API/SDP supply from the manufacturing site, ensuring manufacturing performance, cost, and process robustness requirements are met
- Influences at all organizational levels ensuring project targets are achieved and excellent leadership and negotiation skills with the ability to operate effectively in a multidimensional work environment and collaborate with multi-functional teams
- Own the estimation Supply Chain resource requirements for assigned projects, and ensure proactive technical status communications to leadership
**Qualifications**:
**Qualifications**:
**Education**:
Minimum of a bachelor’s degree, with an Advanced degree preferred in a Scientific or Engineering field such as Chemistry, Pharmaceutics, or Chemical Engineering, with at least 10 years of relevant work experience in the development or manufacturing arena focusing on API with experience in DP as an advantage.
**Experience and Skills**:
**Required**:
- Broad proven technical background in API Chemical manufacturing
-
Lab Analyst
il y a 2 semaines
Antwerpen, Belgique Eurofins PSS Temps pleinAs lab analyst, you will work on different service requests in the research lab of our pharmaceutical client. This includes: - Support liquid state NMR for routine sample preparation & analysis; - Prepare sample solutions aimed at being analyzed by CD and UV spectrophotometry, size-exclusion chromatography for the characterization of the higher-order...
-
Qc New Product Introduction
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps plein**QC New Product Introduction (NPI) Analytical Integrator (M/F/X)** For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business...
-
Site Digital Lead
il y a 4 semaines
Antwerpen, Belgique Johnson & Johnson Temps pleinJohnson & Johnson is currently seeking a Site Digital Lead to join our Launch & Grow site located in Geel, Belgium Do you have a passion for Digital Transformation? If you want to play a leading role making our Launch & Grow site in Geel future proof, this role may be just fit for you! The Geel site is the largest Synthetic Drug Substance manufacturing...
-
Cmc Leader for Dp
il y a 16 heures
Antwerpen, Belgique NonStop Consulting Temps pleinExperienced in CMC drug development, and ready for your next challenge? I am looking for a Project Manager / Principal Scientist experienced in managing formulation projects for new drug products from an innovative company. You will be overseeing projects in injectables, tablets, capsules, liquids, etc. A leading pharmaceutical company, working in various...
-
Product Quality Integrator
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJohnson & Johnson is recruiting for a **Product Quality Integrator (PQI) Director **. The PQI director has end-to-end accountability for the quality strategy and quality aspects of new products from Early Development through commercialization for an assigned portfolio of products. Develops and leads the quality strategies to support new platforms that are...
-
Manager Qc Npi Geel
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJoin **Janssen **Supply Chain, part of the **Johnson & Johnson **Family of Companies! We're actively looking for a skilled and enthusiastic **QC New Product Introduction (NPI) Lead **(M/F/X) to join our dynamic Quality team, overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) and Drug Product (DP) Intermediates in **Geel, Belgium...
-
QA Associate
Il y a 2 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinThis position will be based at our Geel site in Belgium. Change lives for the better. THE OPPORTUNITY Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a QA Associate - QA Lab (M/F/X) as member of our Quality team overseeing the Quality Control laboratories Small Molecule Active...
-
Vp, Global Head Chemical Process R&d
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinAs the world's largest and most broadly based healthcare company, we impact more than a billion lives through the innovation happening at 260+ companies located in 60 countries around the world. Teams from Johnson & Johnson’s Medtechs are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals are using AI to...
-
Site Lead Partnerships
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinWithin Partnerships & External Supply (PES) of Johnson & Johnson Innovative Medicines Supply Chain (Supply Chain), a member of Johnson & Johnson's Family of Companies, we are excited to recruit a Site Lead, Partnerships & External Supply with possible locations in Belgium, Switzerland or Ireland (DS). Would you like to be a part of our team? This position...
-
Pr Eng Rd External Supply Integration
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJ&J Innovative Medicine is recruiting for a Principal Engineer, located in Beerse, Belgium The Principal Engineer is leading drug product supplies and assuring timely delivery of clinical trial material from the DPDS CMO network. They will partner with other functions CSC/DPDS, JSC, JRP and QA to assure all logístical, quality & technical elements are in...
-
Associate Scientist
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJanssen R&D, a member of Johnson & Johnson's Family of Companies, is recruiting for a (senior) associate scientist for the Department of Analytical Development - Clinical Release and Stability (CRS), located in Beerse, Belgium. The Clinical Release and Stability (CRS) team is a critical part of the Global Analytical Development department in the...
-
Quality Associate
Il y a 8 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinWithin J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a **Quality Associate SM-API (M/F/X) **as member of our Quality team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) based in Geel, Belgium. J&J Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the...
-
Msat Scientist
Il y a 6 mois
Antwerpen, Belgique MindCapture Temps pleinMSAT SCIENTIST - Pharma- AntwerpWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and resourcefulness in achieving success. We reward you with competitive salaries and offer a strong package of additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending...
-
Senior Scientist, Manufacturing Sciences
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinThe Scientist position will be based in the **small molecule drug substance **labs as part of Manufacturing Science and Technology (MSAT). The position supports a multi-functional team in developing and deliver solutions required to maintain continued supply of Johnson and Johnson innovative medicines. The position primarily supports the Life Cycle...
-
Msat Scientist
il y a 1 mois
Antwerpen, Belgique Science Talents Temps plein**Introduction**: **Job description**: - The MSAT Scientist Consultant is a member of the Analytical Science and Technology (AST) team in the Recombinant Mammalian Drug Substance (DS) function within the global Manufacturing Science, Analytics and Technology (MSAT) organization and in the biopharmaceutical manufacturing site. The project is responsible for...
-
Senior Business Controller
il y a 6 jours
Antwerpen, Belgique INEOS Styrolution America LLC Temps pleinSUCCEED. IN OUR EXPERIENCED TEAM. For our office/site in **Antwerp** we are looking for a **Senior Business Controller (F/M)** The function combines two roles: Styrene Monomer Controlling EMEA is responsible for setting up the SM EMEA yearly budget and monthly forecasts, assuring correct and compliant monthly financial and management reports for SM EMEA,...
-
Director in Solid State Sciences
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps plein**Working with Johnson & Johnson can change everything. Including YOU.** Pharmaceutical & Material Sciences is, within the Pharmaceutical Development & Supply (PPDS) organization of the Pharmaceutical Companies of Johnson and Johnson, responsible for preformulation & biopharmaceutics, solid state form selection and understanding, and material selection and...
-
Assoc Director Clinical Sply Integrator
il y a 3 jours
Antwerpen, Belgique Johnson & Johnson Temps pleinJohnson & Johnson is currently hiring for an **_Associate Director Clinical Supply Integrator_** that will be located in Wayne, PA; Titusville, NJ; or Antwerp, Belgium. This matrix team leader is responsible for end-to-end supply chain management of clinical supplies. Through the Clinical Supply Sub-Team develops supply strategies matching needs of clinical...
-
Assoc Director Clinical Sply Integrator
il y a 3 jours
Antwerpen, Belgique Janssen Pharmaceuticals Temps pleinJohnson & Johnson is currently hiring for an Associate Director Clinical Supply Integrator that will be located in Wayne, PA; Titusville, NJ; or Antwerp, Belgium. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and...
-
Technical Writer
Il y a 7 mois
Antwerpen, Belgique IntellectEU Temps pleinIntellectEU is an international technology company focused on digital finance and emerging technologies. At IntellectEU we are on a mission to become the top-of-mind fintech company. We are committed to our people and believe in building a better future with the newest of the newest technologies. Giving young people and industry veterans a growing ground to...