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Job Details

Interim Technical Lead - Product and Processes

Company: Hobson Prior
Location: Switzerland
Reference: CM428626
Closing Date: 21 Aug 17
Type: Contract
Salary (£): On Application
Benefits: 100 CHF per hour

Job Summary:

Represents the main technical interface between client and external suppliers by providing technical expertise on manufacturing and packaging process design, process- and cleaning-validation and resolution of technical issues. Applies an appropriate level of product and process oversight to ensure product quality and process robustness.

Requirements:

Job Purpose 

Represents the main technical interface between client and external suppliers by providing technical expertise on manufacturing and packaging process design, process- and cleaning-validation and resolution of technical issues. Applies an appropriate level of product and process oversight to ensure product quality and process robustness. 

Performs the technical due diligence in pre-evaluation phase to select the appropriate external suppliers 

Acts as responsible Technical Transfer Lead to facilitate Product Transfers for legacy products as well as new development products from Client to external suppliers or between external suppliers. Aligns with the Development organization for manufacturing process design during early stage development. 

Acts as the representative in assigned Supplier Relationship Team (SRT). Provides technical / scientific process support to respective Supply relationship teams (SRT) and works in close relation with other SRT members (QA Managers, Site Change Coordinators, Supply relationship Manager etc.) for evaluation of technical compliance activities (Deviations, Change controls, Customer Complaints, CAPAs). Ensures seamless flow of knowledge and information transfer within the organization and across functions with focus on process and product know-how. 


Major Accountabilities 

Technical Interface to external supplier: 
• Establish partnership with external suppliers with focus to ensure and improve product process capability, to keep up to date the knowledge of process and to maintain the product in constant state of validation. 
• Support respective external suppliers with Science- and Risk-based approaches to ensure that product quality can be sustainably reproduced. 

Product/Technical Stewardship for defined key molecules: 
• Act as SPOC and maintain the oversight and knowledge for entire manufacturing process and throughout the entire commercial lifecycle, from transfer from development to current day at given external suppliers. 
• Ensure a proper understanding of manufacturing process and influencing factors (i.e. CQAs, CMAs and CPP) to ensure product quality and process robustness at the commercialization site. 
• Analyze product-specific manufacturing data from APQRs and other relevant sources where needed and agree on state of control 
• Assess impact of technical changes, assess technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of proposed technical changes. 
• Contribute to the registration strategy and ensure alignment of (regulatory) timelines for technical changes, transfers, launches and/or major deviations. 
• Lead / support root cause investigation of product and process failures. 
• Effectively liaise with external suppliers to initiate and lead/support product / process remediation / improvement activities, involving cross-functional teams and with clear interfaces to Quality, Operations, Engineering and Technical Development. 
• Maintain Division and/or cross-division networks to share lessons learned and best practices related with process and technologies. 

Validation – for product(s) in scope: 
• Responsible for the validation oversight and for maintaining the product in constant state of validation. 
• Challenge defined control strategy based on CQA and where necessary on CPP, CMA. prior to validation and for defined improvement projects 
• Review respective Quality Risk Analysis (QRA) prior to validation for technical changes. 
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters. 
• Review validation protocol and report as appropriate. 
• Provide all necessary information to perform the validation documentation, 
• Support Validation Lead and Experts to assess need and plan validations, assess revalidation need. 

Launch & Transfer– for product(s) assigned: 
• Participate in external supplier / product evaluation and selection process. Responsible for gathering technical information on manufacturing process capability at external supplier. 
• Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the giving / receiving site as needed. 
• Define product acceptance criteria for the transfer, agree on acceptable performance on receiving organization and monitor routine manufacturing performance following transfer 
• Ensure successful and well-documented transfers and launches of products with third party manufacturing involvement. 
• Active support for Product Launch and Transfer governance processes 

Interface to Development for the product(s) assigned: 
• Ensure that new products and processes are well developed for the commercial scale and the entire product lifecycle at the commercialization site 
• Provide input to formal stage gates during development and up to first APR/PQR as part of the development process to ensure early integration and to ultimately meet manufacturing requirements 
• Support development of comprehensive control strategy early on in the development to ensure that validation requirements meet regulatory requirements and other critical metrics (e.g., quality, safety, environmental, cycle times, etc.). 

Manufacturing Excellence – for defined product(s): 
• Define and execute design and control optimization projects where needed. 
• Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability. 

Training: 
• Own the Training Curriculum for its Job Description and direct reports. 
 


Ideal Background 

Education (minimum/desirable): 
• BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. 
• Desirable Ph.D., MSc. or equivalent experience. 

Languages: 
• Fluent in English 

Relevant Experiences: 
• Minimum 8 years experience in process development / support or pharmaceutical manufacturing, e.g. Process Expert/Manager role on the shopfloor of pharmaceutical manufacturing and/or QA/QC 
• Proven process understanding (Pharma, GMP, Regulatory aspects). 
• Extended experience in manufacturing (technology) of sterile products. 
• Drug development experience 
• Project Management experience. 
• Sound experience of data handling and applied statistics.

 

 

 

 

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Contact Information:

Address:  Hobson Prior Europe GmbH
D4 Platz 3
6039 Root Längenbold
Luzern
Switzerland
CH-6039
Switzerland
Tel:  t: +41 (0)41 455 25 60
Fax:  f: +41 (0)41 455 25 61
Website:  Visit Our Web Site

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