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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 Senior Manager, Manufacturing Engineering is responsible for leading a team of engineers and scientists who are subject matter experts (SME) for operational execution of the Biologics Manufacturing unit operations. The ideal candidate will have experience with common upstream unit operations such as cell culture, media batching, bioreactors, and centrifugation. This individual will work in a team-driven environment on customer projects to enable transfer to GMP manufacturing. The team will work closely with manufacturing personnel to identify opportunities for improvement, identify best practices, ensure changes are well understood, and to provide technical training.

Duties & Responsibilities

+ Manage operational activities in Upstream of Monoclonal Antibody Drug Substance manufacturing, e.g., technology transfer support, material planning, procedure and batch record preparation, training and troubleshooting, deviation handling.

+ Act as owner of upstream manufacturing MBR and SOP documents, technical approver of validation protocols and final reports, process validation studies and technical documents, critical master drawings, and consumable specifications.

+ Conduct personnel and team performance management through objective setting, development planning, performance appraisal reviews and succession planning.

+ Lead large scale manufacturing operational and equipment improvement initiatives from conception to implementation to improve cadence, simplify operation and improve compliance.

Education & Experience

+ BS or MS degree in Biotechnology, Bio-Chemical Engineering, Biochemistry or related Life Science subject.

+ Direct biologic manufacturing experience of 7+ years with minimum of 1+ years of previous supervisory experience.

Knowledge, Skills, Abilities

+ Extensive knowledge of SOPs and GMPs and the know-how to work and manage within a regulated environment.

+ In-depth knowledge and work experience of biologics upstream manufacturing including cell culture and bioreactors is preferred.

+ Have a deep understanding of the manufacturing value stream e.g., Supply chain, analytical, QA, QC.

Physical Demands

Physical exertion may be required including sitting, standing, repetitive (use of arm, hands, wrists), and walking while working for sustained periods.

Work Environment

Office space, manufacturing space, lab space, inside work, working alone, working with/around others. Role will require appropriate personal protective equipment (PPE) in classified areas.

Supervisory Responsibilities

Supervision of 3-5 direct reports.

Travel

Positions may require up to 5% travel.

Target Bonus

16%

Work Location:

East Syracuse, NY

New York Pay Range

$91,000 — $142,000 USD

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!