Supervisor, Formulation and Fill - 2nd shift

SUN PHARMA; Billerica (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

SUN PHARMA in Massachusetts is seeking a second-shift supervisor (1:30PM–10:00PM) to oversee the preparation, formulation and dispensing of pharmaceutical products in a cGMP environment.

You will author and close investigations, CAPAs, deviations and change controls using root cause analysis and reporting tools, while supervising technicians on the floor and ensuring batch records comply with specifications and SOPs.

Qualifications

• Bachelor's degree or equivalent experience in a life sciences/technical field.
• 6–8 years of experience in pharmaceutical manufacturing.
• Excellent verbal, written and interpersonal communication.
• High level of initiative and self-motivation.
• Ability to plan, prioritize and organize a diversified workload.
• Safe chemical handling techniques.
• Knowledge of SAP, GMP, GDP, FDA, and OSHA regulations.

Responsibilities

• Supervise and perform the activities of technicians on the second shift in equipment and component preparation operations; dispensing API and excipients; formulation and filling and capping of parenteral drug products; oversee dermatological products.
• Schedule weekly plan of floor activities for technicians on second shift
• Author and track to close investigations, CAPAs, deviations and change controls as required
• Troubleshoot and solve moderate to complex problems related to the equipment, processes; existing or new products
• Oversee inventory control in the production area and order supplies as needed for production to assure no delay in the manufacturing plan
• Evaluate team performance by conducting midyear and yearly reviews
• Review completed batch records to ensure product is made in accordance with specifications
• Review SOPs and Batch Records, and update through DCRs as needed
• Work under limited supervision and follows clearly described procedures
• Other duties as assigned
• Education in Life sciences or technical discipline

Skills

Verbal communication

Written communication

Interpersonal skills

Prioritization

Education

Bachelor's degree in Life sciences or related field

Tools

SAP

Job description

This position is a 2nd shift role, 1:30PM - 10:00PM. Supervise and perform regularly the preparation, formulation and dispensing of pharmaceutical products according to our current Good Manufacturing (cGMPs) and utilize Standard Operating Procedures (SOPs) in a clean room environment. Write and complete investigations, CAPAs, deviations and change controls utilizing root cause analysis tools and reporting software.

Area Of Responsibility

• Supervise and perform the activities of technicians on the second shift in equipment and component preparation operations; dispensing API and excipients; formulation and filling and capping of parenteral drug products. Also responsible for overseeing the formulation and filling of dermatological drug products.
• Schedule weekly plan of floor activities for technicians on second shift
• Author and track to close investigations, CAPAS, deviations and change controls as required
• Troubleshoot and solve moderate to complex problems related to the equipment, processes; existing or new products
• Oversee inventory control in the production area and order supplies as needed for production to assure no delay in the manufacturing plan
• Evaluate team performance by conducting midyear and yearly reviews
• Review completed batch records to ensure product is made in accordance with specifications
• Review SOPs and Batch Records, and update through DCRs as needed
• Work under limited supervision and follows clearly described procedures
• Other duties as assigned
• Education in Life sciences or technical discipline

Work Conditions:

• Lab
• Clean room/controlled classified areas
• Manufacturing/production areas
• Office
• Exposure to noise
• Exposure to Chemical/Biological hazards
• Exposure to non-hazardous chemicals
• Exposure to radiation within NRC limits
• Exposure to/use of syringes and needles
• Must wear scrubs/coveralls, safety glasses, safety shoes, gloves as required

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, stoop, kneel, crouch or crawl, climb, talk and hear
• Able to operate lab equipment, production equipment and computer/office machines
• Ability to wear Personal Protection Equipment
• Lift up to 50 lbs.

Up to 0%

Education and Job Qualification

• Bachelor's degree in related field or equivalent experience
• 6 to 8 years of experience in pharmaceutical manufacturing
• Excellent verbal, written and interpersonal communication skills
• High level of initiative and self-motivation
• Ability to plan, prioritize and organize diversified workload
• Safe chemical handling techniques
• Knowledge of SAP, GMP, GDP, FDA, and OSHA regulations and standards

Experience

• Minimum 2 – 5 years of supervisory or team lead experience
• 5 to 7 years of aseptic processing and aseptic area techniques experience
• Experience with technical writing, root cause analysis and completing investigations, CAPAs, deviations and change controls