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About the Role
Performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs, including biotech production activities related to cell culture, drug substance manufacturing, and drug product manufacturing.
Responsibilities
- Assists and/or contributes in all areas of production as needed.
- 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.
- Provides input to production activities scheduling.
- Coordinates regular equipment maintenance and calibrations.
- Ensures all tasks are performed in a manner consistent with safety standards.
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.
- Background checks may be conducted in accordance with the laws of the country where the position is based to verify information prior to employment commencement, such as identity, right to work and educational qualifications.
Location
- On-site
Work Type
- Full-time
Education Level
- BS/BA in Life Sciences or related field
- AS/AAS in Biotechnology/Biological Science
- Equivalent combination of education and experience
Salary/Compensations
- $22.21 - $34.71 hourly
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron is committed to building a workplace with an inclusive culture.
- Regeneron believes we do our best work when we are together.
- Many roles are required to be performed on-site.
Equal Opportunity
- 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.