Associate Director, Laboratory Operations

at  CSL Plasma

37081 Göttingen, Niedersachsen, Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate13 Feb, 2025Not Specified16 Nov, 2024N/ALean Management,GmpNoNo
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Description:

For our Central Laboratory in Göttingen, we are looking for an

POSITION QUALIFICATIONS AND EXPERIENCE REQUIREMENTS:

  • University Degree in Business or Science
  • Masters Degree in Sciences preferred
  • At least 10 years of progressive experience in a laboratory management, leading personnel and working within matrixed organizations.
  • Lean Management
  • Quality and GMP skills
  • Good IT skills
  • Cost awareness
  • Fluent in German and English

Responsibilities:

MAIN RESPONSIBILITIES AND ACCOUNTABILITIES:

  • Manage staff, including recruiting, selection and training, coaching, developing and terminating as applicable with guidance from Human Resources.
  • Manage the capacity and organizational capability to perform tests and deliver test results required for the release of Normal Source Plasma and specified other types of plasma, per customer specifications, within CSL cost targets. Manage the resolution of technical and process issues, assuring safety and recovery is timely.
  • Lead the site to ensure all tests carried out in the Göttingen laboratory are carried out in accordance with Good Manufacturing Practice (GXP), CSL standards and regulatory requirements.
  • Responsible to drive Laboratory culture. This should be done through development of effective strategies, management of employee performance and engagement by providing regular feedback, staff development, coaching, while conducting annual employee appraisals.
  • Lead and coordinate projects to improve Lab infrastructure and facility to meet current and future needs, focused on growth and automation, while using Lean Management and continuous improvement principles.
  • Ensure accurate forecast modeling and alignment of resources to optimally handle the workload. Develop and implement annual budget, building a bottoms-up budget and then monitoring performance against it. Participate in the forecasting process, aligning lab operations with business performance expectations.
  • Participate in major supplier contract negotiations and lead minor ones. Ensure Lab maintains excellent R&D relationships at key supplier companies. Support assays developments that are potentially more cost-effective or accurate for the Lab. Maintain and manage key supplier relationships.
  • Establish Lab Operations Key Performance Indicators. Identify trends and issues requiring resolution. Manage difficult problems, escalating where necessary and leading detailed investigations to assure achievement of committed goals.
  • Work closely with IT, HR, Finance, QA/Compliance, Engineering Services and other corporate functions on initiatives that affect the business. Teach them about the Lab to help make good decisions and learn from them how to make the Lab run better. Create linkages to other lab experts in the CSL Group as appropriate.
  • Oversee the drafting, review and updating of SOPs to ensure all laboratory processes are correctly defined and described in the SOPs and are in line with relevant regulations and internationally recognized GMP standards.
  • Perform job-related duties as assigned.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Business or science

Proficient

1

37081 Göttingen, Germany