USP MA I

Job Description:

General Summary:
 

Executes upstream manufacturing of clinical and commercial products. Executes pre and post processing activities such as:  clean of production equipment, including the operation of automated bioreactor, harvest and media prep skids. This position is accountable for executing the manufacturing processes in Contract Manufacturing Facility and/or Master Cell Banking Facility. 
 

Essential Duties and Responsibilities:
 

• Ability to work with bioreactor operation and cell culture including aseptic technique
• Execute and monitor critical processes supporting mammalian, microbial, and fill finish production facilities
• Solid experience with the following:  large-scale centrifuges, washers, autoclaves
• Ability to contribute to the development of new concepts, techniques, and standards
• Assist Facilities and Engineering personnel as necessary on equipment maintenance and calibration
• Interface with Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps.
• Provide support to cross-functional teams to meet production or timeline demands.
• Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practice.
• Adhere to Quality standards and learn and comply with regulatory requirements.
• Provide suggestions for process optimization and efficiency, where applicable.
• Operate manufacturing equipment in assigned area
• Write standard operating procedures (SOP’s) and other documents as necessary
• Complete manufacturing documents such as batch records, logbooks
• Assist in the execution of validation protocols
• Ability to accurately analyzes and processes scientific data
• Ensure the completeness and accuracy of manufacturing documentation per approved procedures
• Identify and support the implementation of process efficiencies and areas for improvement
• Ensures solutions are consistent with organization's objectives
• Demonstrate ability to perform all process steps upstream and/or support production operations
• Ability to generate SOPs for equipment and procedures used in the manufacture of biological products

Job Requirements:
 

• Associate Degree - Science or Biotech or 1 to 2 years in GMP environment with experience in GMP production including aseptic processing, chromatography, TFF, Final Formulation and Filling.
• Experience in mammalian cell culture or protein purification a plus
• GMP manufacturing experience preferred. Will train qualified candidates.
• Good mechanical aptitude
• Detail oriented
• Able to follow written instructions and document work performed
• Experience with validation and startup preferred
• Must be flexible, able to work within multifunctional teams as well as changing schedules. Occasionally required to work nights.

Physical Demands: 

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand and sit. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds.

Work Environment: 
 

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; toxic or caustic chemicals; and risk of electrical shock. The noise level in the work environment is usually moderate. A large amount of the work is completed in a cleanroom environment.  While working in the area the gowning requirements are safety glasses, shoe covers, hood, gown, mask boots and gloves.  Working conditions can include standing for long periods of time

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.

Cytovance Biologics acknowledges that providers may be a valuable resource for identifying and recruiting Candidates for employment. However, we require that all external recruiters engage directly with Cytovance Biologics Human Resources Team and comply with Cytovance Biologic’s requirements prior to transmitting any Resumes/CV’s or introducing any candidates to an employee of Cytovance Biologics. Cytovance Biologic’s Human Resource Team is the only function within the Company that can enter contractual relationships with external recruiters and recruiting agencies.