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 Manager, Manufacturing Operations provides first line supervision of operation and matrix reporting support staff. This role is responsible for Biologic Operations schedule execution including area cleaning, environmental monitoring, maintenance, operations and validation activities on a 24 hour/7 day per week schedule.
Duties & Responsibilities
Provides process oversight, spending 90% of shift time out on the production floor
Responsible for ensuring that all manufacturing and support activities are carried out to the highest standards of GMP and EHS compliance
Responsible for adherence to manufacturing and support activity schedule
Provides regular feedback and performance coaching to the manufacturing operators
Holds regular discussions on career development with direct reports
Responsible for personnel and team performance management including performance connections, acceleration of development action plans and succession planning
Accountable for real time review of all manufacturing documentation
Ensure that all batch documentation generated on shift has been fully completed prior to shift exchange
Responsible for communication of progress and escalation of non-conforming events
Responsible for managing Tier 1 meeting and communication board in manufacturing area
Responsible for initial data gathering and reporting of safety incidents and deviations and entry into relevant systems
Makes process decisions and provides troubleshooting within scope of established procedures
Responsible for permit writing and approval for within boundary of manufacturing
Responsible to ensure proper handoff for manufacturing equipment and rooms
Ensures that the area is always inspection ready by conducting daily GEMBA walks and weekly GMP walkthroughs with QA Field
Performs weekly time management system approval of non-exempt staff
Accountable to ensure all staff are trained and proficient in accordance with the job functions assigned
Responsible to champion OPEX principles in manufacturing including standard work, 5S, visual management, human error reduction and tier meetings
Supports implementation of CAPA into routine manufacturing operations
Responsible for review of procedural updates as part of CAPA implementation or errors identified by operators during execution
Education & Experience
Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
Direct biologic manufacturing experience of 6+ years. Previous supervisory experience is desirable
Extensive knowledge of working in a regulated environment and the importance of following procedures, cGMPs and EHS and the skillset to work and manage within a regulated environment
Strong knowledge of biopharmaceutical manufacturing processes with a proven record in biopharmaceutical technology
Strong change management skills and demonstrated ability to simplify and improve business processes
Excellent leadership skills with the ability to motivate and manage a team with matrix reporting relationship
Adaptable to a fast paced, complex and ever-changing business environment
Effective verbal and written communication skills with technical writing skills
Proficiency in the use of computers and business software applications
Yellow and/or green belt certification in lean manufacturing/operational excellence is strongly desired
Knowledge, Skills, Abilities
Strong working knowledge of cGMP requirements and regulations FDA, EMA
Strong working knowledge of both local, state and OSHA requirements in relation to environmental, health and safety.
Strong understanding of safety hazards (steam, pressure, chemical, etc.) and best practices for safe working behaviors.
Qualified trainer with ability to successfully coach and supervise people and teams.
Ability to create an environment of trust, compliance, safety, continuous improvement and learning.
Excellent problem solving, decision making and communication skills.
Change agent with demonstrated history of continuous improvement.
Strong knowledge of MS Excel, Word and PowerPoint is preferred.
Ability to work across the matrix to direct and support critical functions that support manufacturing including maintenance and quality.
Physical Demands
This position is located a medium scale manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE). This role will require contact with hazardous materials such as caustic, acids and steam. Frequent bending,
twisting, squatting, kneeling, climbing and reaching is required. Role also requires infrequent unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hand/wrists, grasping is also required. This position is a team-based position that requires shift work, weekends, holidays and overtime.
Work Environment
This position is for a supervisory position in a manufacturing facility with classified areas requiring appropriate gowning and personal protective equipment (PPE). This role will require working with hazardous conditions and materials such as caustic, acids
and steam. Powdered materials and high temperature liquids are also handled.
Supervisory Responsibilities
This position will supervise a staff of 6-10 hourly employees.
Shift Differential
5%
Target Bonus
10%
Work Location:
East Syracuse, NY
New York Pay Range
$76,000 - $113,000 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!
