Specialist in Process Development

Type of job: full-time

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

Department: Technical Operation
Responsible To: Quality Control & Process Development Manager

Position Summary:

Responsible for optimization, characterization, automation and general development of GMP Manufacturing and Quality Control related to particular IMP (investigational medicinal product). Participates in development of new IMP. Directly reports to the Quality Control & Process Development Manager.

Key Activities and Responsibilities:

· Participates in process development for new products and technologies from the 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, effective, 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:

o Internal or external audits

o Regular controls of manufacturing processes and processes of quality control

o CAPA investigation

o 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 in internal and external meetings, audits and business or technical meetings with third parties.

· If needed, exceptionally participates in manufacturing of IMP

Competences, Skills and Qualification:

· University education, Ph.D. in biology, pharmacy or biochemistry

· Upper Intermediate or preferably advanced knowledge of English

· Solid communications skills

· Practical experience in cell cultures or pharmaceutical manufacturing

· Conscientiousness, reliability

Offer:

· Interesting work

· Very good salary

· Company benefits (e.g. bonus, pension contribution, 1 week extra holiday, sick days, multisport, meal vouchers etc.)

· Professional growth, good team

Start date is upon agreement.

In case of interest for more information, please contact us (see below).

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.

Contact:
Ing. Lada Drobišová, MBA

Telephone:
+420 722 950 102

Updated: 14.6.2019