Manufacturing Lead - 1st Shift

Purpose
The objective of this position is to perform manufacturing operations required to produce pharmaceutical products in a timely manner compliant with cGMP, OSHA, and other regulatory requirements. The Manufacturing Lead will become qualified and independently capable of performing all aspects of internal cold manufacturing operations. Such operations include, but are not limited to, receipt and transfer of materials and components into the manufacturing unit operation, component and equipment cleaning and preparation, operation of automated manufacturing equipment with good aseptic technique, completion of production transactions within the ERP system, completion of paper-based production records and forms in accordance with GDP. Equipment utilized by the Manufacturing Technician IV includes parts washers, sterilizers, tanks and vessels, single-use assemblies, filter integrity testers, automated filling equipment, inspection and packaging equipment. Additionally, this position is required to own the training of colleagues on the manufacturing equipment and processes.
Key Responsibilities/Essential Functions

• Upholds, fosters, and demonstrates the Lantheus core values: Let people be their best; Respect one another and act as one; Learn, adapt and win; Know someone's health is in our hands; Own the solution and make it happen
• Leads daily operations including, but not limited to, the material transfer, preparation, batching, filling, inspection and ancillary operations associated with the manufacture of pharmaceutical products.
• Demonstrates ability and willingness to receive direction and coaching from supervisor and manager.
• Able to work effectively and re-prioritize work activities in a dynamic manufacturing environment.
• Enters, checks and reviews data for accuracy and completeness, independently.
• Interacts positively with team members to coordinate functions and maximize efficiency.
• Resolves routine and non-routine manufacturing problems independently or by utilizing the appropriate technical group resource and problem-solving techniques.
• Utilizes knowledge, experience, and group resources to make decisions regarding routine issues.
• Excels in cross-functional communication.
• Excels in communicating in situations involving pressure.
• Demonstrates a strong understanding and strict compliance with standard operating procedures (SOPs)
• Able to develop, revise, and create SOPs.
• Demonstrates the ability to apply knowledge of the cGMP Regulations (Parts 210 and 211) to routine and non-routine situations.
• Demonstrates knowledge and advanced understanding of operating computer-controlled automated production equipment.
• Demonstrates the ability to obtain a high knowledge of applicable software.
• Performs numerous tasks ranging from basic to complex functions.
• Performs inventory moves and material transactions within the ERP system, specifically SAP.
• Coordinates the procurement of various materials from the warehouse needed for manufacturing processes.
• Directly supports efforts of other groups as part of daily responsibilities, including:


• Coordination of WFI and Steam usage to support production.
• Participation and support of maintenance staff while troubleshooting or making equipment repairs.
• Operating manufacturing equipment to support engineering studies or validation protocols.
• Coordination with metrology to provide calibrated devices in a timely manner.
• Support of capital project planning and execution, as related to impact on manufacturing operations.
• Coordination with microbiology and disinfection for routine and non-routine disinfection and sampling


• Recommends and drives process/quality improvements.
• Recognizes and suggests personal objectives which complement and support group and organizational goals. Influences others in meeting their group objectives through support and cooperation.
• Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.

Basic Qualifications

• Bachelor's degree in a science related field and 3-5 years of experience in a pharmaceutical/biotech manufacturing environment
• Associate degree in a science related field with 5-7 years of experience in a pharmaceutical/biotech manufacturing or quality environment.
• A combination of education, training and experience may also be considered.
• Working in a clean-room environment and previous experience with cGMP's is a plus.

Other Requirements

• Knowledge of company product portfolio and manufacturing processes
• Exhibits a desire to learn and cross-train within the organization.
• Confidence in interpersonal relationships with ability to stop operations, coach/mentor and course correct
• Ability to work in accordance with cGMP guidelines.
• Familiarity with aseptic technique
• Practical working knowledge of computer systems and platforms
• In-depth knowledge of manufacturing equipment and new technologies
• Hands-on experience with manufacturing processes and problems, including troubleshooting, scale-up, and optimization efforts.
• Ability to train others through the qualified On-the-job training process.
• In the case of supervisory absence, the incumbent will function as a backup.
• May include working holidays, weekends, and mandatory overtime, as needed.