Wafer Process Development Manager jobs in Syracuse, NY

Overview

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 an Associate Scientist, Downstream Process Development. This role will report into the Manufacturing Science and Technology (MSAT) organization. The primary role of this position is to execute laboratory experiments in the development, optimization, characterization, and scale-up of biologics downstream purification processes from laboratory to manufacturing scale using knowledge of chromatography, dead-end and depth filtration, centrifugation, tangential flow ultrafiltration/diafiltration, viral inactivation, and viral filtration.

The role is a combination of laboratory- and office-based work. This role will execute and document laboratory studies in laboratory notebooks and will also support documentation review, protocols, technical reports, change controls, and CMC regulatory submissions under supervision. This role is expected to follow detailed GLP/GMP procedures and safety requirements and work in a team environment and will interact with other functional departments. This is a team-based position that may require work on evenings, weekends, and holidays.

Remote Position

Min Compensation

Max Compensation

Bonus

Qualifications

Education/Experience:

• Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related industry experience in biologics downstream manufacturing or manufacturing technology: B.Sc/B.Eng with 3-5 years or M.Sc./M.Eng degree with 0-2 years
• General scientific knowledge and laboratory skills. Knowledge in downstream purification (chromatography, dead-end and depth filtration, centrifugation, tangential flow ultrafiltration/diafiltration, viral inactivation and viral filtration) is preferred
• Experience with experimental statistical design and data analysis is preferred
• Experience in problem solving ability and ability to apply risk-based critical thinking in a technical environment is desired
• Technical communication skills in written and verbal presentation format are essential
• Ability to complete assignments in a timely and compliant manner within given timelines

Specific Knowledge, Skills, Abilities:

• Leverage an understanding of the drug substance downstream purification process to support execution and data analysis of scale-down chromatography and filtration laboratory studies for process development, process characterization, and process validation
• Support development of the downstream purification process control strategy through identification of critical process parameters and process attributes
• Support process technical transfers from laboratory-scale or pilot-scale to manufacturing-scale
• Support process optimization, process robustness initiatives, process troubleshooting, process yield improvements, and process-related investigations at manufacturing-scale through conducting scale-down studies
• Document execution and results of experimental plans in laboratory notebooks, perform data verification, and author and review SOPs and downstream purification documentation to capture experimental designs and results via protocols and other associated scientific technical documents for process development, process characterization, as well as validation protocols with supervision
• Support continuous process improvements and advance technology for implementation in laboratory and manufacturing operations
• Prepare buffers and reagents, as well as support operation and maintenance of laboratory equipment, including HPLCs, purification columns, spectrometers, and centrifuges
• Support CMC review and verification of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.), with interactions with global Health Authorities for inspections
• Work with other team members and on cross-functional technical teams

Physical Demands/Work Environment:

• Laboratory-based position which requires appropriate levels of personal protective equipment (PPE). This role may require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step stools, and reaching may be required. This role may also require unassisted lifting (not to exceed 50 lbs).  Repetitive use of arms/hands/wrists and grasping may also be required
• The position is based indoors and the individual will primarily be working with others, but also independently and alone at times in the laboratory
• The office-based work will require sitting
• The position is a team and project-based position that will require occasional shift work, weekends, evenings, and holidays
• Dynamic, fast-paced, interactive, and entrepreneurial environment 

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

http://www.lottebiologics.com/

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.