What are the responsibilities and job description for the Manufacturing Associate I- Downstream (Nightshift Position) position at Cytovance Biologics?
Job Description:
General Summary:
This position is for nightshift only
This position is accountable for the execution of procedures for purification manufacturing and support area of manufacturing using SOP’s and batch records. Operating production equipment for purification that may include process monitoring, purification and formulation.
Essential Duties and Responsibilities:
- Perform in-process testing where applicable.
- 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.
- Provide suggestions for process optimization and efficiency, where applicable.
- Accurately follow SOP’s for operating production equipment and performing processing steps
- Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities Assume ownership of production areas and associated equipment.
- Assemble, prepare, and maintain process equipment; chromatography skids, columns, TFF systems, and ancillary equipment.
- Complete and review GMP documentation and production records for accuracy and make corrections in a timely manner.
- Initiate non-conforming events and execute corrective actions / preventative actions.
- Adhere to Quality standards and learn and comply with regulatory requirements.
- Additional duties as assigned
Job Requirements:
- Associate Degree - Science or Chemical Engineering or 2 year of experience in a GMP production and purification including aseptic processing, chromatography, TFF, Final Formulation and Filling and buffer preparation.
- Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment.
- Must be proficient in Word and Excel.
- Ability to interpret process trends and data and react appropriately to unexpected outcomes.
- Innovative spirit, strong initiative and work ethic, and positive attitude.
- Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.
- Detail oriented
- Able to follow written instructions and document work performed
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.
