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Biopharmaceutical Production Specialist
2 months ago
Overview:
BioPharma Consulting JAD Group is actively looking for a Biopharmaceutical Production Specialist to become a vital part of our organization.
The Biopharmaceutical Production Specialist will engage with various technologies (Upstream, Downstream, or Buffer Preparation Unit Operations). In this capacity, you will be tasked with executing manufacturing operations in accordance with Standard Operating Procedures (SOP) within a GMP-compliant manufacturing setting.
Key Responsibilities:
Upstream Operations:
Utilization of Single-Use Cell Culture Vessels/Bioreactors up to 2000L
Management of Bacterial Fermentation Culture Vessels up to 2000L
Operation of Alpha Wasserman Continuous Flow Centrifuge
Handling of Disposable Magnetic Mixing Bags and Totes
Cell Expansion and Propagation processes
Banking/Cryopreservation of Cell Lines and Viruses
Implementation of Hyperstack, Cellstack, and other Adherent Cell Technologies
Conducting plate counting and microscopic examinations
Monitoring cultures, sampling, bioreactor and fermenter turnaround, sterilization, and inoculation
Downstream Operations:
Management of medium to large-scale filtration systems including Tangential Flow Filtration (TFF),
Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration, and depth filtration
Operation of medium to large-scale Chromatographic systems (ÄKTA).
Utilization of Pre-Packed Columns from 1L to 100L
Management of Single-use mixing systems (Pall & GE)
Handling of Single Use connectivity types such as GE DAC and Colder AseptiQuik
Execution of bulk filling
- Aseptic process simulation and drug product filling
Buffer Preparation Operations:
Preparation of media from stock raw materials, including compounding, mixing, testing, and filtration for subsequent processing needs
Preparation of buffers from stock raw materials, including compounding, mixing, testing, and filtration for subsequent processing needs
Weighing of raw materials according to batch record specifications and assigning appropriate expiry per procedures
Integrity testing of filters
Essential Duties:
Draft and review standard operating procedures, buffer formulation records, and batch production records.
Support senior personnel in the implementation of project safety and quality assurance programs in alignment with SOPs.
Safeguard the confidentiality of proprietary company information.
Document and maintain activity records in compliance with cGMP regulations and ensure training for junior team members.
Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
Conduct daily cleaning and sanitization of laboratory and manufacturing areas.
Foster effective working relationships with colleagues.
Perform all other assigned responsibilities.
Required Skills & Competencies:
Exceptional oral and written communication skills, along with strong interpersonal and organizational abilities.
Proficiency in Microsoft Office applications.
Capability to train others to adhere to cGMP standards.
Strong self-discipline and meticulous attention to detail.
Excellent mathematical and computer skills.
Experience in a cleanroom environment with full cleanroom gowning and proficient aseptic technique.
Possess effective planning and time management skills, and be willing and able to collaborate with colleagues across various roles and functions within the manufacturing facilities.
Master's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or a related field with three (3) years of relevant experience OR
Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or another related field with one to five (1-5) years of relevant manufacturing experience in a GMP or regulated industry; OR
Associate's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or another related field and two to seven (2-7) years of relevant experience; OR
High School/GED with four to nine (4-9) years of relevant experience.
Additional Requirements:
Must be flexible with work hours and willing to work outside of standard scheduled hours as necessary.
Preferred Qualifications:
Experience in GMP environments
Green-Belt Certification
Preferred Biotechnology certificate.
Cross-training in other identified functional areas
Experience with mammalian, insect, yeast, or bacterial cell lines and their cultivation and/or purification of biologics or viral vectors.
