Principal Scientist, Process Microbiologist, Manufacturing Science and Technology at LOTTE Biologics

ID
2023-3390
Category
Production Support
Position Type
Regular Full-Time
Location : Location
US-NY-East Syracuse
Location : Postal Code
13057

Overview

Lotte Biologics Company Logo

 

We are LOTTE Biologics! A new company, built on 80 years of tradition!

 

We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

 

We deliver therapies that make a Healthier World!

Responsibilities

To help us meet our mission LOTTE Biologics is in need of a Principal Scientist, Process Microbiologist in the Manufacturing Science & Technology (MSAT) department to lead the overall process microbial control strategy for various customer processes. The Principal Scientist will use scientific understanding of biologics process risks to identify potential bioburden entry points into the production process, assess the needs for bioburden control at different production process steps, confirm performance is expected under process conditions, and monitor the process to confirm maintenance of bioburden control. The incumbent will collaborate with Process Development, MSAT, Manufacturing, Supply Chain, Quality Control (QC), Microbiology Control, and Aseptic Quality Operations (AQO), Quality Assurance (QA), as well as Facilities and Engineering to design the bioburden control process map. The Principal Scientist will be responsible for identifying risks and severity levels to inform planning of process raw material selection, process elements and conditions, establishment of process alert/action levels, and selection of appropriate monitoring and detection methods. Additionally, the Principal Scientist is expected to remain current on industry trends and ICH guidelines, while also directly interacting with customers and health authority agencies to communicate the process control strategy elements.

  • Collaborate across partner functions including Process Development, MSAT, QA/QC, Microbiology Control, AQO, Manufacturing, and Facilities and Engineering to define the process bioburden control strategy and specification limits by developing a fundamental understanding of microbiological impacts to the biomanufacturing processes
  • Identify technical approaches to define, design, execute, and documents laboratory-scale process microbiology experiments and characterization study designs to improve process microbiology knowledge, establish microbial control elements, and define process specifications including alert/action levels for process steps and raw materials
  • Develop effective bioburden/endotoxin control plans and mapping strategies showing process inputs and risks contributing to bioburden loads specific to individual customer programs
  • Author documentation including process control strategies, standard operating procedures, and study protocols and reports to address both preventative and remedial actions at each process unit of operation
  • Identify, develop, and implement technologies for microbiological detection and characterization in partnership with the Microbiology Control and AQO for processes and in the manufacturing facilities
  • Demonstrate in-depth knowledge of potential contamination sources for the production process and the production facility to support selection of process equipment, development of cleaning and sanitization requirements and capabilities, preventative maintenance, bioburden monitoring, and remedial actions as appropriate
  • Lead and author microbiological process risk and severity assessments
  • Author process microbiology CMC regulatory sections and ensure familiarity with ICH, industry, and regulatory guidelines
  • Demonstrate familiarity with microbial detection assays (bioburden and endotoxin) and laboratory-scale purifications
  • Support process-related investigations and deviations around bioburden and endotoxin
  • Maintain processes at inspection readiness level and provide internal or external audit support
  • Apply formal processes and tools to manage the transfer of information, process-related risks, and change controls
  • Remain current on ICH guidelines, industry trends, and peer-reviewed literature to anticipate, evaluate, and resolve process-related challenges within microbiology area of expertise

Remote Position

No

Min Compensation

USD $91,000.00/Yr.

Max Compensation

USD $142,000.00/Yr.

Bonus

16%

Qualifications

Education/Experience:

  • Degree in Life Sciences/Engineering, Biology, Biochemistry, Biotechnology, Biomolecular Engineering, Chemistry, Microbiology, Molecular Biology or equivalent area working in Manufacturing/Contract Manufacturing: B.Sc/B.Eng degree with 9-12 years, M.Sc/M.Eng degree with 6-9 years, or Ph.D degree with 4-6 years of relevant industry experience
  • Significant professional experience as a process expert or similar position in clinical and/or commercial biomanufacturing, preferably in a microbiology laboratory with a good understanding of regulatory and cGMP requirement is desired
  • Knowledge of mammalian-based biologics manufacturing processes, with expertise in at least one area of drug-substance bioprocessing such as cell culture/fermentation or protein purification, as well as process development, manufacturing support, and/or protein chemistry is preferred
  • Experience in cleaning topics related to Biopharmaceutical Manufacturing in multipurpose facilities including leading risk assessments and validation is preferred
  • Experience with cGMP regulations, regulatory requirements and CMC authoring for biologics process validation and manufacturing are necessary
  • Demonstrated problem solving ability, interpersonal, and oral and written communication skills are essential, along with strong leadership skills

Physical Demands:

  • Position requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs.
  • Occasional bending, twisting and stooping to allow for gowning into classified environment required.

Work Environment:

  • Position is primarily office based with occasional work in a classified GMP manufacturing environment.
  • Dynamic, fast-paced, interactive, and entrepreneurial environment 
  • Position is a team and project-based position that will require occasional shift work, weekends, and holidays.

Travel:

This position requires up to 10% of domestic and/or international travel.

 

Work Location:

East Syracuse, NY

 

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities.  If this is the work that you want to do in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today! 

 

Company Website

Company Profile

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

 

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.  With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.

 

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

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