Specialist in Process Development (biotechnological company)

Typ práce: hlavní pracovní poměr

For my client, prestigious biotechnological company I am looking for Specialist in Process Development.

Department: Technical Operation

Responsible To: Quality Control & Process Development Manager

Location: Prague, Czech Republic

Employment Type: Full time employment

 Position Summary

Responsible for development, optimization, characterization and automation of cell and gene therapy investigational medicinal products. Directly reports to Quality Control & Process Development Manager.

Key Activities and Responsibilities

• Participates in process development of new products and technologies from preclinical through pilot plant and manufacturing scale.
• Participates in manufacturing and quality control automation projects performed within Process Development department.
• Optimizes existing process and technologies for the purpose of creating more efficient and compliant manufacturing and operational processes. Responsible for planning, performance and proper documentation of laboratory experiments within optimization, development, characterization, stability or validation studies.
• Participates in preparation and revision of standard operating procedures (SOP) of manufacturing and quality control processes.
• Participates in quality assurance processes:
• Internal or external audits
• Regular controls of manufacturing processes and processes of quality control
• CAPA investigation
• Change requests
• Provides training for QC and manufacturing associates
• Participates in preparation of documents for regulatory authorities
• Represents departmental activities as needed, including project teams, presentations at internal and external meetings, audits and business-related activities with third parties.
• If needed, exceptionally participates in GMP manufacturing of IMP

Competences, Skills and Qualification

• University education, Ph.D. in biology, pharmacy or biochemistry
• Upper-Intermediate or preferably advanced knowledge of English with solid communications skills
• Proven experience and knowledge of cell biology/molecular biology/biochemistry related laboratory techniques
• Advantage is previous experience from the biotech or pharmaceutical manufacturing company and knowledge of GMP
• Advantage is knowledge of cell culture techniques, gene therapy, flow cytometry, PCR
• Conscientiousness, reliability

Offer

• Interesting work
• Very good salary
• Company benefits (e.g. bonus, pension contribution, 2 weeks extra holiday, multisport, meal vouchers etc.)
• Professional growth, good team

Start date is upon agreement.

In case of interest for more information, please contact Ing. Lada Drobišová, MBA. Phone number: 722 950 102.

If you are interested in the position, please send your CV at lada.drobisova@LDHR.cz.

In sending your CV you give your consent to processing and holding of your personal data in accordance with the General Data Protection Regulation (EU) 2016/679. regarding personal data protection by LD Human Resources s.r.o., ID: 24275336 until a written form revocation. Your personal data can be provided to third persons in order to obtain employment, namely after prior approval.

Kontaktní osoba:
Ing. Lada Drobišová, MBA.

E-mail:
lada.drobisova@LDHR.cz

Telefon:
+420722950102

Vloženo: 11.11.2021