Assoc Biotech Production Specialist

Summary: Performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs.

Essential Duties and Responsibilities include, but are not limited to, 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.
• Provides input to production activities scheduling.
• Coordinates regular equipment maintenance and calibrations.
• Ensures all tasks are performed in a manner consistent with safety standards.

Education and Experience:

• Requires BS/BA in Life Sciences or related field or AS/AAS in Biotechnology/Biological Science or equivalent combination of education and experience.

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

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (hourly)

$22.21 - $34.71