Production Associate, Cell Based Therapies

SCOPE:               

The individual will conduct cGMP manufacturing of a cell-based product. This includes validation and development runs under cGMP and assistance in technology transfer of novel products.  All activities will be performed in a cGMP-compliant environment

RESPONSIBILITIES:

• Execute procedures to manufacture cell therapy products ensuring that production batch records are completed at the highest standards according to Company policies and procedures.
• Assist with review and organization of completed batch records, address deviations and support investigations as necessary.
• Perform daily clean room activities such as equipment/material preparation and cleaning/sanitization of equipment and rooms including packaging and disposing of biohazard waste per established procedures.
• Assist in ordering and transfer of materials and maintain supplies adequate for production demands. Stocking of non lot controlled materials and cleanroom garments and provide assistance to maintain vendor service relations.
• Assist with execution of environmental monitoring of air, surfaces and personnel in classified areas.
• Provide assistance with employee training as required
• Provide assistance with authoring and revision of Batch records, SOPs, Temporary changes, Item Specifications and other cGMP documentation.
• Collaborate with and assist other groups with projects by executing protocols associated with validation, technology transfer, etc.
• Perform other duties as required.

QUALIFICATIONS:

• For level II minimum two years of relevant experience for level III four years of experience.
• Preferred Bachelor degree in Biology, Science or related field or Associates degree with relevant experience in clean room manufacturing
• Experience with cell culture and/or molecular biology and aseptic techniques is strongly preferred.
• Hands on experience working in GMP environments is preferred.
• Good communication skills to clearly convey complex information and ensure proactive communication in timely manner.
• Must have strong computer skills.
• Must be able to communicate effectively with co-workers and be willing to collaborate closely with co-workers and other groups.
• Must have initiative, high attention to detail, and the ability to multi-task
• Flexibility with work schedules and duties including necessary extended hours, weekends and holidays.
• Ability and willingness to be regularly, predictably, and reliably at work.

Physical Demands: Majority of work is sedentary with sitting, standing, and bending. Some occasional physical demands such as: pushing, pulling, and lifting up to 30 lbs. Good dexterity and balance required. Work will require working with Biohazardous, small quantities of chemical materials, as well as ultra-cold temperatures while wearing personal protective equipment.

The requirements listed in this job description are representative of the management’s assignment of essential function, with knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Furthermore, the job description doesn’t constitute a contract of employment and CoImmune Inc. may exercise its employment-at-will at any time.

EOE