Biotech Production Specialist - Fill Finish
Regeneron Pharmaceuticals Inc

New York, New York

Posted in Pharmaceuticals


This job has expired.

Job Info


We are currently looking to fill a Biotech Production Specialist - Fill Finish, with all shifts; 1st, 2nd, and 3rd, with potential for double weekend days. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Biotech Production Specialists are on the front line, producing life changing products. They perform all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs.

As a Biotech Production Specialist, a typical day might include the following:

  • Assists and/or contributes in all areas of production as needed.
  • Includes all aspects of biotech production activities related to cell culture.
  • Monitors production processes including cell culture and purification activities for drug substance manufacturing and filling, and inspection and packaging activities for drug product manufacturing.
  • Reviews, edits, completes and revises completed batch records, logbooks and SOPs in accordance with cGMP standards and compliant with written procedure.
  • Ensures availability of production batch records for upcoming lots.
  • Performs manufacturing-level maintenance and cleaning of equipment.
  • Participates in equipment start-up, commissioning and validation activities.
  • Ensures equipment operational readiness.
  • Assists with troubleshooting in case of equipment failure.
  • Gathers, trends and analyzes process generated data.
  • Participates in defining robust process parameters during routine manufacturing campaigns.
  • Works to optimize, trend and report manufacturing process operational parameters during routine manufacturing campaigns.
  • Creates process evaluation reports, process transfer documentation and process characterization presentations.
  • Documents all training.
  • Assists with training of new employees.
  • Performs various tests and analytical procedures.
  • Performs in-process sampling, quality control chemistry and quality control microbiology.
  • Keeps process area stocked with essential equipment and components.
  • Ensures all tasks are performed in a manner consistent with safety standards.
  • Provides input to production activities scheduling.
  • Coordinates regular equipment maintenance and calibrations.
This role might be for you if:
  • You want to support our amazing team to produce the highest quality medicines for patients as efficiently as possible to change people's lives
  • You are driven to challenge the status-quo and develop a culture where continuous improvement is not just a metric but rather an approach for everyone, every day, to do better
  • You are not easily frustrated with a meticulous process of change control, investigations, and corrective actions
  • You enjoy project oriented work with a career goal of becoming a subject matter expert
  • You thrive in a fast-paced setting where your priorities can quickly change based on the needs of the business and our patients
  • You are smart, adaptable and great at problem solving
  • You prosper in a culture of trust, teamwork and transparency
  • You are driven to constantly improve processes and procedures to find the most efficient and effective way to make it happen, everyday
  • You are capable of pushing, pulling, and lifting at least 50 pounds

To be considered for the Associate Biotech Production Specialist - Fill Finish, you must be willing and able to work all shifts; 1st, 2nd, and 3rd, with potential for double weekend days. You must have the following; BS/BA in Life Sciences or related field or AS/AAS in Biotechnology/Biological Science or equivalent combination of education and experience.

To be considered for the Biotech Production Specialist - Fill Finish role, you must be willing and able to work all shifts; 1st, 2nd, and 3rd, with potential for double weekend days. You must have one of the following; BS/BA in Life Sciences or related field or AS/AAS Degree/Certificate in Biotechnology/Biological Science, or an equivalent combination of education and experience and a minimum of 2 years of relevant experience.

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.


This job has expired.

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