Job Detail

Technical Launch Integrator, Drug Product Operations - (180000DJ) 

Actelion Pharmaceuticals, a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for a Technical Launch Integrator, Drug Product Operations in Allschwil.

As part of 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 cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

Actelion is a leader in the field of pulmonary hypertension (PH). Our portfolio of PH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

 

Role Responsibilities

• Lead and manage technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management, budget) including launch support and technical  and manufacturing integration of new and re-developed drug products from R&D into the supply chain


• Partnering with internal functions to develop and implement strategies to improve the fit for plant, commercialization and life cycle of new and existing products into the supply chain


• Ensure sufficient and timely supplies for the market, based on input from the planning & procurement function, and for commercial validation and launch production


• Ensure all required technical project activities are initiated and completed according to the development stage


• Lead the technical drug product activities:


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  • Leading the DP manufacturing site team and manufacturing site representative on the Discovery & Manufacturing Sciences DP-Development Sub-team and the JSC New Product Team
  
  
  • plan, organize and administer the different aspects of the technical activities required for technical transfer to the Janssen supply chain including characterization, development, clinical supplies, scale-up, validation and manufacturing of commercial supplies
  
  
  • Maintain contact and seek support of other internal technical functions to ensure comprehensive and adequate technical development.
  
  
  • Ensure compliance with regulatory guidelines and adapt to new initiatives
  
  


• Ensure that medicinal products are manufactured and controlled according to adequate quality standards


• JSC technical input and technical acceptance of DP into the supply chain including cost and robustness metrics through a process of “touch points”, thereby ensuring “one voice of the customer” towards R&D and consistency across projects and across plants


• Contribution, review and approval of drug product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc), routine technical support during execution, integration of JSC technical expertise (e.g., platforms, engineering, SME’s) into project execution and QbD technical implementation at the manufacturing site level.


• Single point of contact for Janssen Supply Chain (JSC) plant readiness and execution from technical transfer into commercial production (e.g. tech transfer implementation, site based documentation, planning, risk management, budget) including launch support.

 
Candidate Requirements

• University degree in pharmacy, chemistry or equivalent  technical/science university degree: master level minimum, PhD preferred


• With minimum 5 years of relevant experience in the pharmaceutical industry in pharmaceutical product development and/or pharmaceutical manufacturing or similar operational positions.


• Capability leading interdisciplinary teams of scientists working on pharmaceutical development and/or commercial projects


• Scientific expertise in small molecule drug product and manufacturing


• Experience in the pharmaceutical process development with focus on up-scaling, launch and technical transfer


• Knowledge and understanding of drug product manufacturing process, quality control, packaging and distribution


• Thorough knowledge of (c)GMP/GDP, quality control and production processes based on current guidelines.


• Knowledge in QbD and DOE.


• Basic understanding of business processes related to supply chain and ERP


• Ability to negotiate, plan, and coordinate technical development and manufacturing activities


• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics


• Strong leadership, self-confidence, assertiveness, autonomy and open personality with proven team spirit as to motivate and convince people and demonstrated ability to influence stakeholders.


• Strong planning and priority setting capabilities


• Fluent English required (oral and written)

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.

 

Primary Location

: CH-BL-Allschwil

Job

: Technical Operations

Schedule

: Full-time

Job Type

: Standard

Job Posting

: Oct 25, 2018