What are the responsibilities and job description for the Fill/Finish Associate position at Regeneron?
We are currently looking to fill a Fill/Finish Associate. The Fill/Finish Associate performs all duties related to the production and support of drug product manufacturing. Works individually, and as part of a team, to support and perform operations to maintain formulation, filling, assembly, labeling and cartoning/packing equipment for parenteral biological products. Seeks to understand and develops proficiency in processes or procedures of increasing complexity.
As a Fill/Finish Associate, a typical day might include the following:
Produces life-saving therapeutics for various indications developed from a dynamic internal pipeline
Works with a team that is accountable for production activities ranging from formulation of drug product to packaging of final drug product, which may include the following process-related responsibilities:
Operates highly automated equipment to fill drug product into vials or syringes within isolators or other aseptic environments
Assembles filled drug product into syringes and autoinjectors
Operates state of the art packaging lines to place assembled and labeled drug product into packaging configurations for distribution
Monitors production line for proper operation through process controls including pneumatics, robotics, manual and PLC feedback loop systems
Cleans, handles, and installs interchangeable parts for various systems and equipment
Collaborates to create and maintain operating procedures to perform routine activities that adhere to regulatory expectations
Ensures working spaces and equipment are clean, safe, and ready for processing activities
Maintains gowning qualification and adheres to clean room behaviors wherever required
Performs environmental sampling using various methods where applicable
Records GMP data that is accurate, legible, attributable, and contemporaneous and completes review on those records
Maintains and ensures proper documentation of all training
Navigates and utilizes electronic systems to support manufacturing operations
Travel (domestic and international) may be required.
Ensures compliance with applicable procedures while executing activities and escalates any non-conformities during operations
Performs reconciliation of product and controlled materials where applicable
This role might be for you if:
Ability to perform basic algebra and geometry
Reading/writing skills
Must be able to stand for extended periods of time and lift, push and pull at least 50lbs.
Knowledge of cGMP and FDA regulated (preferred) manufacturing environment and familiarity with cGMP filling, assembly or packaging processes preferred.
Necessary to have keen attention to detail and demonstrate from previous work experiences.
Preferred experience with aseptic technique and operating filling equipment or with assembly or packaging of parenteral products in vials, syringes and cartridges using both manual and automated equipment preferred.
Basic understanding of Microsoft Office Suite.
Demonstrates strong interpersonal, cross-cultural, communication, negotiation and has a high emotional IQ.
Exhibits confidence and strong problem-solving skills and demonstrates ingenuity, creativity and resourcefulness.
Gains understanding from provided instructions and works towards established goals.
Understands and listens to team members and stakeholders’ needs while supporting a positive team environment.
Possess a strong and effective communication style among peers and with management team
Supports the development and maintenance of a diverse and inclusive environment.
Values and acts with integrity
Shift Requirements: Physical
Ability to perform physical requirements for entirety of shift (up to 10 hours):
Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs
Gowning and Environment
Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
To be considered for the Fill/Finish Associate you must have a GED/High School diploma and previous work experience.
Level is figured out based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (hourly) $16.20 - $38.56
As a Fill/Finish Associate, a typical day might include the following:
Produces life-saving therapeutics for various indications developed from a dynamic internal pipeline
Works with a team that is accountable for production activities ranging from formulation of drug product to packaging of final drug product, which may include the following process-related responsibilities:
Operates highly automated equipment to fill drug product into vials or syringes within isolators or other aseptic environments
Assembles filled drug product into syringes and autoinjectors
Operates state of the art packaging lines to place assembled and labeled drug product into packaging configurations for distribution
Monitors production line for proper operation through process controls including pneumatics, robotics, manual and PLC feedback loop systems
Cleans, handles, and installs interchangeable parts for various systems and equipment
Collaborates to create and maintain operating procedures to perform routine activities that adhere to regulatory expectations
Ensures working spaces and equipment are clean, safe, and ready for processing activities
Maintains gowning qualification and adheres to clean room behaviors wherever required
Performs environmental sampling using various methods where applicable
Records GMP data that is accurate, legible, attributable, and contemporaneous and completes review on those records
Maintains and ensures proper documentation of all training
Navigates and utilizes electronic systems to support manufacturing operations
Travel (domestic and international) may be required.
Ensures compliance with applicable procedures while executing activities and escalates any non-conformities during operations
Performs reconciliation of product and controlled materials where applicable
This role might be for you if:
Ability to perform basic algebra and geometry
Reading/writing skills
Must be able to stand for extended periods of time and lift, push and pull at least 50lbs.
Knowledge of cGMP and FDA regulated (preferred) manufacturing environment and familiarity with cGMP filling, assembly or packaging processes preferred.
Necessary to have keen attention to detail and demonstrate from previous work experiences.
Preferred experience with aseptic technique and operating filling equipment or with assembly or packaging of parenteral products in vials, syringes and cartridges using both manual and automated equipment preferred.
Basic understanding of Microsoft Office Suite.
Demonstrates strong interpersonal, cross-cultural, communication, negotiation and has a high emotional IQ.
Exhibits confidence and strong problem-solving skills and demonstrates ingenuity, creativity and resourcefulness.
Gains understanding from provided instructions and works towards established goals.
Understands and listens to team members and stakeholders’ needs while supporting a positive team environment.
Possess a strong and effective communication style among peers and with management team
Supports the development and maintenance of a diverse and inclusive environment.
Values and acts with integrity
Shift Requirements: Physical
Ability to perform physical requirements for entirety of shift (up to 10 hours):
Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs
Gowning and Environment
Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
To be considered for the Fill/Finish Associate you must have a GED/High School diploma and previous work experience.
Level is figured out based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (hourly) $16.20 - $38.56
Salary : $16 - $39
