Germany Job Openings
ProtaGene GmbH
Director Biologics (Head of Quality Control-Analytics) (m/f/d)
Dortmund
November 8, 2024
Job description
- Lead, manage, and develop multiple laboratory teams, fostering a culture of excellence and continuous improvement
- Report directly to senior management on all HQC and operational activities, ensuring alignment with company goals
- Oversee protein analytical methods, including method development, release testing, and stability studies
- Manage a diverse method portfolio including (U)HPLC-SEC, -IEX, RP-HPLC, LC/MS, amino acid analysis, and analytical ultracentrifugation
- Supervise all quality control systems, ensuring compliance with GMP, ICH and AMWHV regulations and functioning as the Head of Quality Control
- Ensure the release of laboratory results, including overseeing method transfers and co-validations according to ICH guidelines
- Ensure the writing, review, and approval of GMP documents, including SOPs, plans, reports, deviations, changes, OOS, etc.
- Maintain strict adherence to regulatory guidelines, supporting quality audits and inspections
- Support the development and optimization of biologic methods, utilizing Design of Experiment (DOE) and other advanced methodologies to determine identity and purity
- Drive the implementation of new technologies and automation in QC processes to enhance efficiency and accuracy
- Oversee the efficient and economic management of the laboratory, optimizing processes to meet project timelines and customers’ expectations
- Participate in personnel and budget planning, ensuring resources are effectively allocated
- Work closely with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to meet project objectives and ensure timely delivery of analytical reports
Job requirements
- Ph D or master’s degree in Biochemistry, Molecular Biology, Biotechnology, or a related field
- A minimum of 4 years of experience in Quality Control within the (bio)pharmaceutical industry in a GMP environment, with at least 2 years in a leadership role
- Experience with an extensive portfolio of protein and peptide analytical techniques, including (U)HPLC-SEC, -IEX, RP-HPLC, LC/MS, amino acid analysis, and analytical ultracentrifugation
- Extensive knowledge of biologics manufacturing, analytical techniques, and regulatory requirements (GMP, FDA, EMA, etc.)
- Proven experience in managing and developing high-performing QC teams
- Strong analytical and problem-solving skills, with a track record of successful investigations and CAPA implementation
- Excellent communication and interpersonal skills, with the ability to influence and collaborate across all levels of the organization
- Experience with QC laboratory management, including equipment qualification and method validation
- Proficiency in data analysis software and Laboratory Information Management Systems (LIMS)
- Strong organizational skills with the ability to manage multiple projects and priorities in a fast-paced environment
- Economic thinking and experience in dealing with laboratory key figures
We offer
- Responsible and varied tasks in a motivating working environment
- A permanent position in a dynamically growing international life science group with over 200 employees
- Optimal induction and training opportunities as well as individual development options
- Appreciation, openness and respect as well as a lively feedback culture
- Flat hierarchies, short decision-making processes and flexibility
- Comprehensive health management
- Job-Bike leasing
- Regular company and team events
- Heilbronn, Baden-Württemberg, Germany
-
- Dortmund, Nordrhein-Westfalen, Germany
New Job Alerts
Pwc Germany
Rechtsreferendar Legal (w/m/d)
Frankfurt am Main
FULL TIME & PART TIME
November 19, 2024
View Job Description
Pwc Germany
Praktikum / Werkstudent Legal (w/m/d)
Berlin
FULL TIME & PART TIME
November 19, 2024
View Job Description
implantcast
Ingenieur:in / Meister:in / Techniker:in als Teamleiter:in Finish Medizintechnik
Buxtehude
November 19, 2024
View Job Description
Pava Partners Germany AG
Vice President/Director M&A (m/w/d)
Leipzig
FULL TIME
November 19, 2024
View Job Description
Löwenstein Medical SE & Co. KG
Leiter entwicklungsbegleitendes Qualitätsmanagement für Medizinprodukte (m/w/d)
Hamburg
November 19, 2024
View Job DescriptionLooking for similar job?
GfK
Account Director CMT Multinationale Kunden (m/w/d) (CPS-GfK)
Frankfurt am Main
FULL TIME
October 7, 2024
View Job Description
Wipro Limited
Business Development Director (Automotive) M/F/D
Frankfurt am Main
October 7, 2024
View Job Description
Milliken and Company
Global Market Director, Coating Additives
Langenfeld (Rheinland)
October 5, 2024
View Job DescriptionNew Job Alerts
Pwc Germany
Rechtsreferendar Legal (w/m/d)
Frankfurt am Main
FULL TIME & PART TIME
November 19, 2024
View Job Description
Pwc Germany
Praktikum / Werkstudent Legal (w/m/d)
Berlin
FULL TIME & PART TIME
November 19, 2024
View Job Description
implantcast
Ingenieur:in / Meister:in / Techniker:in als Teamleiter:in Finish Medizintechnik
Buxtehude
November 19, 2024
View Job Description
Pava Partners Germany AG
Vice President/Director M&A (m/w/d)
Leipzig
FULL TIME
November 19, 2024
View Job Description
Löwenstein Medical SE & Co. KG
Leiter entwicklungsbegleitendes Qualitätsmanagement für Medizinprodukte (m/w/d)
Hamburg
November 19, 2024
View Job Description