Lead Biotech Production Specialist (Aseptic)

Location
Rensselaer, New York, United States of America
Posted
Jul 02, 2021
Ref
24957BR
Required Education
Bachelors Degree
Position Type
Full time
Summary: Serves as Lead and also performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs.

Please note that this position is 2nd shift, Friday-Monday, from 1:00 p.m.-11:30 p.m.

Leadership-Related Activities include, but are not limited to, the following:
• Provides on-the-floor leadership to employees;
• Ensures employees timesheets are completed on time;
• Participate with employees training, to ensure that all requirement are met;
• Perform minimally monthly performance feedback meetings with direct reports;
• Escalates all performance issues to Manager and/or Directors and/or HR.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Includes all aspects of biotech production activities related to cell culture.
• Assists/contributes in all areas of production as needed.
• 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 on equipment.
• Monitors production processes.
• Participates in equipment start-up, commissioning, and validation activities.
• Ensures equipment operational readiness
• Assist 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.
• Assist 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.

Education and Experience:
• BS/BA in Life Sciences or related field or AS/AAS Degree/Certificate in Biotechnology/Biological Science and one year of related experience.
• Or equivalent combination of education and experience.

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.