Operations Technician/specialist

Serán BioScience provides custom formulation, process development and clinical manufacturing services for a variety of pharmaceutical clients. Our Operation Department seeks an Operations Technicians and Operations Specialists to play an integral role in maintaining specialized equipment for the manufacturing of tablets, capsules and spray drying dispersion for the use of early phase clinical FDA trials. Adhering to strict standard operating procedures (SOP) and following good manufacturing practices (GMP) are required. Successful candidates will demonstrate strong attention to detail and focus within a fast-paced work environment with experience in teamwork, self-discipline, and proactive communication to ensure collective goals are achieved. Training available on-site. Those exhibiting successful candidate characteristics without pharmaceutical experience are encouraged to apply.

Duties and Responsibilities

• Strictly follows standard operating procedures (SOP).
• Complies with Good Manufacturing Practice (GMP).
• Completes documentation, including logbooks, batch records, and quality records.
• Maintains an organized, clean, and stocked production area.
• Cleans tools, rooms, and equipment after use.
• Weighs, measures, subdivides, and disposes of product components.
• Safely handles and disposes of hazardous materials.
• Operates specialized machinery to manufacture pharmaceutical products under supervision.
• Works closely and communicates effectively with operations team.
• Performs other related duties as assigned.

Required skills and Abilities

• Mechanical aptitude.
• Strong verbal and written communication skills.
• Strong organizational skills and attention to detail.
• Proficient in basic math.
• Strong time management skills with ability to meet deadlines.
• Ability to prioritize and ask for assistance to delegate tasks when appropriate.
• Ability to focus in a fast-paced environment with shifting priorities.
• Proficient with Microsoft Office Suite or related software.

Education and Experience

• High School Diploma or equivalent.
• Coursework or experience in chemistry or manufacturing field preferred.
• Operations Specialist require a minimum of 1 year of GMP experience within pharmaceutical manufacturing

Physical Requirements

• Prolonged periods of sitting or standing while monitoring equipment.
• Must be able to lift up to 25 pounds regularly, and up to 55 pounds occasionally.
• May require ability to work swing or weekend shift with the possibility of 12-hour shifts.
• Must be able to wear a Tyvek suit with PAPR for extended periods of time.
• Exposure to constant low-level equipment noise, and occasional high-level alarms.
• Work near heat generating equipment.
• Must be able to operate a forklift.
• Move up and down ladders, kneel, squat, balance on one foot.
• Move mop above head while cleaning room surfaces.