LOTTE BIOLOGICS located in East Syracuse, NY is seeking a Senior Specialist Quality Control - Bioanalytics to join their team who entered the biologics Contract Development Manufacturing Organization (CDMO) business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site on January 1, 2023!

The Senior Specialist, Quality Control - Bioanalytics performs Quality Control testing for in-process, release, stability, and raw materials/water in a cGMP environment, supports routine data analysis, OOS, OOT, and OAL investigations, and demonstrates familiarity with scientific techniques and practices within area of study.

A successful candidate for the position of Senior Specialist, Quality Control - Bioanalytics within the Syracuse Quality Control (SQC) organization will perform or be responsible for the following:

• Ability to accurately perform and document laboratory work.
• Demonstrate familiarity with scientific techniques such as Bioassay, ELISA, qPCR, and Surface Plasmon Resonance and practices within area of study
• Demonstrate the ability to work independently on assays within realm of experience and training while requiring limited situational-dependent supervision.
• Demonstrate the highest level of good documentation practices and instruct others with less experience on the best documentation practices.
• Be a proficient user of instrumentation and related computer systems
• Perform instrument performance checks and calibration within realm of experience and training.
• Assist in the modification of SOPs as required and recognize when an SOP revision or new SOP is required to maintain compliance.
• Demonstrate on-going proficiency in the performance and theoretical understanding of a broad range of assays.
• Execute and assist in technical transfer and co-validation activities after demonstrated proficiency in assay.
• Perform data review based on demonstrated proficiency in assay within realm of experience and training.
• Individual will need to have the ability to recognize atypical results and trends within the realm of experience and training.
• Perform basic troubleshooting of instrumentation.
• Train and assist less experienced scientists within area of expertise with assays
• Individual will become a qualified trainer
• Be recognized by other QC scientists as in-house expert user of instrumentation and related computer systems in their area of responsibility

A candidate for the Quality Control Senior Specialist position should have:

• Previous hands-on training and GMP experience within the laboratory setting.
• Advanced applied knowledge and depth of understanding of analytical techniques such as Bioassay, ELISA, qPCR, and Surface Plasmon Resonance.
• Proficiency in the performance and theoretical understanding of analytical methodology

Education/Experience/ Licenses/Certifications:

Quality Control Senior Specialist must have:

• Minimum BS degree in scientific area with 5-10 years of related experience
• Demonstrated theoretical understanding of scientific area of study and ability to train others.
• Demonstrated problem solving ability, interpersonal, oral and written communication skills.
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
• Demonstrated contributions to a team based, collaborative, and positive environment, clarity of purpose and high commitment to business goals.
• Demonstrated expertise of applicable instrumentation and computer related software

Physical Demands:

• Vision (Acuity, color-correction allowed.)
• Reaching (Shoulder)
• Repetitive (Use of Arm, Hands, Wrists)
• Unassisted lifting of items, not to exceed 50 lbs
• Bending/Stooping

Work Environment: 

This position is a lab-based position which requires appropriate levels of personal protective equipment (PPE). 

This role will 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 need to be handled.
• Use of instrumentation that includes lasers may be required.
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching is required.
• This role also requires frequent unassisted lifting (not to exceed 50 lbs).
• Repetitive use of arms/hands/wrists and grasping is also required.
• Depending on the work demands, office-based work requires sitting.
• This position is based indoors and primarily requires working with others, but also independent/alone work at times.
• This position is a team-based position that may require shift work, weekends, and holidays.

Travel: 

• This position requires up to 5% of travel

Supervisory Responsibilities:

• This position may require supervision of other staff on an as needed basis, to cover absences of team lead/ supervisor/ and/or manager.

Work Location:

East Syracuse, NY

http://www.lottebiologics.com/

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.