We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World.

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.

Position Summary

The Quality Control Manager is responsible for laboratory operations within a functional area of expertise that support the onsite commercial biologics manufacturing facility, as well as applicable network and third-party manufacturing facilities. Functional areas of expertise include Bioseparations, Bioanalytical, In Process, and Chemistry methodologies for the testing of raw materials, manufacturing samples, and drug substance/drug product release samples. The Manager is accountable for ensuring a safe, quality driven, efficient, and robust culture while continuously challenging inefficiency at every opportunity. This position is a primarily an office-based position, however, requires routine entry into laboratories to review data, verify compliance, and access instrumentation in support of daily lab activities and laboratory investigational process.

Duties & Responsibilities

• Oversee all operations functions within area of expertise to direct the development, implementation, and refinement of standards, methods, procedures, laboratory facilities for execution of testing and reporting in accordance with cGMP and SOPs.

• Responsible to oversee the effective execution of daily operations of a biologics QC lab testing and reporting of raw material, in process, and final drug substance release samples to support the manufacturing of bulk drug substance

• Oversee and/or develop staff schedules to meet workflow demands of the 24/7 manufacture of drug substance and on time release of final bulk drug substance

• Responsible for ensuring all activities are carried out to the highest standards of cGMP and EHS compliance

• Provide technical and operational expertise for the training and development of staff, assistance in troubleshooting, conducting investigations for out of specification results

• Responsible for the development of high-quality team members with diverse backgrounds and talent capable of delivering against established goals and objectives

• Create an environment of continuous learning, improvement, and innovation.

• Responsible for adherence to SOPs, Directives, cGMPs, FDA, OSHA, ICH, and other regulatory agency requirements

• Ensures all personnel have adequate training, education, and experience to perform their GMP related job function effectively.

• Serve as Subject Matter Expert and participate in the site team supporting regulatory inspections and audits

• Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and improve laboratory efficiency

  Education & Experience

Minimum B.S. degree in a scientific area with greater than 5 years’ experience, M.S. degree with 4 years’ experience, or Ph.D. with some experience working in a cGMP laboratory.

Knowledge, Skills, Abilities

• Demonstrated expert level theoretical and technical knowledge in area of concentration; skills, hands on training, and cGMP experience within the laboratory setting are required.

• Expert level instrumentation experience in area of concentration.

• Familiarity with pharmaceutical regulations and general compendia (USP/EP/JP) methodology and instrumentation requirements is required.

• The candidate must be self-directed with a high degree of professional integrity, be organized, and detail oriented.

• Demonstrated problem solving ability and effective technical trouble shooting is required.

• Strong interpersonal, oral and written communication skills required.

• Demonstrated ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail and to contribute to a team based, collaborative, and positive environment ensuring clarity of purpose and high commitment to business goals.

• Demonstrated ability to work independently.

  Physical Demands

Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on stepstools, 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.

Work Environment

This position is office based; however, it requires intermittent laboratory testing and requires the use of appropriate levels of personal protective equipment (PPE). This role will require safe interaction with biohazardous materials. Powdered materials and high temperature liquids and solids are also handled. This position is based indoors and primarily involves working with others, but also independently at times. This position is a team-based position that may require shift work, weekends, and holidays.

Supervisory Responsibilities

This position directly supervises the Quality Control - In Process Evening shift team.

Travel

<5% travel required

Shift Differential

10%

Target Bonus

10%

New York Pay Range

$76,000 — $113,000 USD

Work Location

East Syracuse, NY

We are an Equal Employment Opportunity (“EEO”) Employer.

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!