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Process Development Scientist

Houston, TX

Posted: 03/05/2021 Job Number: JN -032021-12641

Job Description

Process Development Scientist

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

  • Title: Process Development Scientist
  • Location: Houston, TX
  • Industry: Pharmaceutical
  • Hours: Monday-Friday - 8am - 5pm
  • Salary: $29.74hr (Paid Weekly)
  • Employment Type: Long Term Contract
Environment: A global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.

Job Summary:

Seeking a Manufacturing Science and Technology Scientist. As a member of the MSAT Team (Manufacturing Science and Technology), you are responsible for the successful transfer of processes into production. As such, you are in direct contact with our clients and Research & Development scientists. You ensure process scalability and manufacturability. You are the person in charge for process integration related aspects during campaign preparation and you are responsible for process supervision and reporting during and after production campaigns. In addition, you will coordinate all process relevant major deviations and process adaptations and you are responsible for continuous improvement of the manufacturing processes.

Key responsibilities:
Functional Lead for Process Technology Transfer: The MSAT Scientist will be responsible for the successful transfer of Viral Vector Processes into GMP production. The incumbent will collaborate with MSAT Sr. Scientists and cross-functional teams, including Process Development (PD), Manufacturing, Quality Assurance, Supply Chain, and Program Management among others to ensure on time delivery of Technology Transfer activities. The MSAT Scientist will also represent Lonza at client facing meetings.
  • Technical Subject Matter Expert (SME):
The incumbent will act as SME within the MSAT team as well as for other Lonza teams. The activities include but are not limited to, performing process fit-to-plant and Failure Modes and Effects Analysis (FMEA)-based risk assessment, characterizing and scaling-up equipment , authoring and reviewing Process Flow Diagrams, Bill of Materials, and reviewing and approving Production Batch records. The incumbent will also provide technical support to GMP execution of the new processes and critical unit operations. Technical support to Deviation Investigations, Corrective Action Prevention Plans (CAPAs), and Change Controls is also expected.
  • Data Management:
The MSAT Scientist will perform detailed review of processes from Clients and PD of various operational parameters. The incumbent will initiate Part Numbers and Material Specifications, generate Technology Transfer documents (e.g. protocols, reports, process summary), perform process monitoring (manufacturing data analysis, summary, and presentation), author campaign summary reports and recommend improvements for MSAT practices and procedures.

Key requirements:
  • Bachelor s Degree required in a field of study such as Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or other life science fields.
  • Related Master of Science or PhD degree is a plus.
  • Experience with Biologics Process Development, Technology Transfer and/or Manufacturing.
  • Work experience in Upstream Processing (adherent and/or suspension cell culture, scale-up and bioreactor operation) and/or Downstream Processing (Chromatography operation, Ultrafiltration/Diafiltration (UF/DF), Tangential Flow Filtration (TFF), and Filtration).
  • Work experience in viral vector Process Development or Manufacturing is a plus.

EOE/ADA


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