For our Plasma Product Development R&D department we are looking for a
Manager, PPD Process Development (f/m)
(full-time / permanent)
The Manager, PPD Process Development is responsible for managing a laboratory within the department with all corresponding administrative responsibilities and for the professional supervision of employees in the laboratory and for the evaluation of laboratory studies. In addition, the incumbent will provide scientific support for development studies at down/ kilo/ pilot plant scale. .
Main Responsibilities and Accountabilities
- Responsible for the professional supervision of employees in the laboratory including leading, motivating, training and development staff and building of effective teams:
- Providing effective leadership and management of laboratory including:
- Ensure data integrity and scientific consistency in Process Development experiments
- Conduct risk assessments
- Ensure all labs and equipment are maintained in a state of operational readiness to meet quality standards and execute objectives against timelines
- Assure that experiments are performed according to current scientific rational, regulatory /internal guidelines, legal requirements and quality standards
- Evaluate study results for quality and plausibility, release of results and data transfer for biometric analysis.
- Supporting strategic thinking for the Process Development group in the context of process optimization and yield improvement projects including:
- Executes on the business plan. Area of responsibilities include:
- Process development studies: Evaluate and implement opportunities for improvement of current production processes. Support changes and modifications to the existing manufacturing processes.
- Provide support to the assessment of authority-related issues.
- Support of execution of activities at downscale, kilolab scale, pilot scale and commercial scale
- Provide support for tech-transfer of production process to all CSL sites.
- Support departmental/ interdepartmental and global tech transfer from downscale/ kilolab scale to pilot scale or from pilot scale to commercial scale
- Support internal and global cross-functional expert teams regarding feasibility studies and consistency batches in production by providing expertise on site in manufacturing.
- Ensuring agreed targets for quality, timelines, costs, and user requirements are met
- Planning work and resources
- Providing cost estimates for internal and external customers
- Full documentation of Process Development activities according to appropriate Quality standards and in support of IP
- Support of regulatory filings and regulatory audits as appropriate
- Maintains awareness of cGXPs, good scientific practices, and promote lab and office safety
- Counsel CSLB’s Intellectual Property group in the field of coagulation, write and examine patents and patent applications.
- Provides effective and transparent communications within laboratory, department but also interdepartmental
- Prepare assessments / reports / presentations in English/German to support regulatory submissions or other departments and present study results in German and English internally/ globally.
Qualifications / experience
- University degree, typically PhD, in a relevant field of science e.g. in biotechnology / biochemistry / biology or corresponding qualification based on work experience in a relevant field.
- Proven ability to be independent and self-motivated, demonstrating strong organizational and communication skills.
- Strong scientific background in aspects of protein biochemistry, protein purification, blood coagulation, protein analytics and quality assurance.
- Experience in project work. Excellent communication and analytical skills.
- Strong planning and organizational skills. Fluent in English, oral and written.
- Proficient computing and software skills (MS office suite, DOE, instrument software, statistical and graphical analysis, LIMS systems, business management systems).
If you are interested in this challenging position, please apply via our website.
CSL Behring GmbH
Position number: R-072945
Worker Sub Type:Regular
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