Manufacturing Technician IV

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary

The objective of this position is to perform manufacturing operations of chemicals, components and finished product and to ensure that they are performed in a timely manner compliant with all cGMP, OSHA, NRC, DOT, and other regulatory requirements based on business need. Responsible for all aspects of the finishing operations processes including but not limited to , preparation of chemicals, reagents, and components used in the manufacture of finished radioactive products. Also included is support for the re-qualification of sterilizers and other manufacturing equipment, routine maintenance of finishing operations equipment and ensuring supplies are available for use in designated areas.

Key Responsibilities/Essential Functions

* Demonstrated the competency of all major duties and responsibilities of Manufacturing Tech I, Manufacturing Tech II, and Manufacturing Tech III.

* Plans and adjusts own schedule to meet changing priorities on a daily basis. Coordinates multiple tasks daily and weekly.

* Demonstrates expert knowledge of manufacturing processes, including preparation, batching, filling, and ancillary operations associated with the manufacture of radiopharmaceuticals up to and including being considered a SME for purposes of Quality investigations or internal audits.

* Checks and reviews data for accuracy and completeness, independently. Provides Production Authority review for all documentation in designated area of expertise.

* Interacts positively with team members to coordinate functions and maximize efficiency.

* Resolves 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.

* Communicates effectively across departments.

* Communicates effectively in situations involving pressure.

* Reads and follows operation manuals and SOP's.

* Demonstrates the ability to apply knowledge of the cGMP Regulations (Parts 210 and 211) to routine situations.

* Demonstrates knowledge and fundamental understanding of operating computer-controlled production equipment.

* Demonstrates knowledge of applicable software.

* Demonstrates expert knowledge and troubleshooting skills in a radiopharmaceutical production environment.

* Performs numerous tasks ranging from basic to complex functions.

* Works with new team members to train and improve understanding of processes, equipment, and good cGMP practices within the manufacturing team.

* Performs inventory moves and material transactions within the ERP system.

* Troubleshoots inventory discrepancies.

* Performs Cycle Counts and Reconciliations within the ERP system.

* Coordinates the procurement of various materials from the warehouse needed for manufacturing processes.

* Actively procures additional manufacturing operating supplies from appropriate outside vendors.

* Performs Weekly Scheduling of operations, considering production needs, lead times, and material expiries.

* Works with Process Support to coordinate WFI and Steam use and recommends ways to for more effective use.

* Schedules calibrations of assets and equipment that do not fall under the scope of Metrology department, submits service requests to put new assets into service and removes assets from service if necessary.

* Recommends process/quality improvements. Offers innovative solutions to manufacturing problems. Works with Supervision to lead the implementation of approved changes.

* Reviews, edits, and updates SOPs and Batch Records within QUMAS.

* 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.

* Actively demonstrates the Lantheus values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety.

Basic Qualifications

* Bachelor's Degree in a science related field and 3 - 5 years of experience in a pharmaceutical/biotech manufacturing environment.

* Associates Degree in a science related field and 5 - 7 years of experience in a pharmaceutical/biotech manufacturing environment.

* High school diploma with 7 - 10 years of experience in a pharmaceutical/biotech manufacturing or quality environment.

* Working in a clean-room environment and previous experience with cGMP's.

* Experience with Component Preparation, Batching/Formulation, and Fill and Finish operations.

* A combination of education, training, and experience may be considered in lieu of above stated requirements.

Other Requirements

* Knowledge of company product portfolio and manufacturing processes.

* Ability to work according to cGMP guidelines.

* Demonstrated tenure and advanced understanding of aseptic technique and clean room practices.

* 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 trouble-shooting, scale-up, and optimization efforts.

* May include working holidays, weekends, and mandatory overtime, as needed.

* Ability to pass eye exam on an annual basis, either corrected or uncorrected.

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.