Pilot R&D Associate

Job Title

Pilot Plant R

Organization Name

InvaGen Pharmaceuticals

Location

594 Airport Rd, Fall River, MA 02720. (927 Currant Rd when required)

Employment Type

(Hourly/ Full Time)

Professional/Exempt

Salary Range

(Base/ Hourly)

$65,000 – $87,000 (DOE)

Work Hours/ Shift/ Remote

8:30 AM – 5:00 PM (may vary based on business requirements)

Responsibilities/ Accountabilities

To execute the activities as defined in Duties and responsibilities for proper functioning of R&D with cross functional teams and to fulfil regulatory requirements.

Duties and Responsibilities

• Dispensing of raw and primary packing materials as per work order.
• Ensure the proper planning and execution of batches.
• Ensure cleaning and sanitation of production area and machinery as per respective SOP during batch to batch and product to product changeover.
• Daily monitoring and recording of production materials and production lines.
• Monitor process checks and ensuring recording in batch manufacturing record.
• Address and escalate (when required machine operations issues with maximum rejections and minimum outputs while maintaining quality standards within the standard norms when addressing the issue.
• Ensure that the necessary maintenance of operating equipment has been performed.
• Safeguard equipment for smooth functioning with co-ordination of engineering for preventive maintenance and calibration.
• Manufacturing, filling and packing of products as per Batch Manufacturing and Packing Records and SOP.
• Coordinating with other departments like packaging, engineering, QA and QC for better planning and execution.
• Sampling includes in-process as per schedule informing and coordinating with QA, engineering and other CFT’s to ensure operation continuity or taking proper action to ensure compliance with batch manufacturing and packing.   
• Check and ensure status labels at all stages of manufacturing, packing and filling.
• Perform, check and ensure calibration/verification of instruments, equipment and weighing balances as per schedule.
• Online documentation and timely entries related to manufacturing and filling operations and activities.
• Ensure all safety requirements required for handling of propellant HFA-152a and any other hazardous material.
• Produce requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures.
• Performing other related duties assigned.

Other Responsibilities and Competencies

• Ability to update job knowledge by participating in training opportunities.
• Flexibility working across any shifts (1st, 2nd & 3rd) during when assigned to meet batch manufacturing schedules and/or other operational needs.
• Working individually and in collaboration with others as part of a team.
• Maintain 100% cGMP and SOP Compliance during complete operation hours.

Education and Experience

• Must have a minimum of a bachelor’s degree from an accredited university in pharmaceutical sciences or relevant field.
• At least one (1) year of experience in Pharmaceutical Industry is preferred (including internship).
• Proficiently speak English as a first or second language
• Have excellent organization, learning and teaching skills required to work in teams.

Physical Requirements

• Able to lift 15 pounds with or without assistance.
• Able to frequently stand, bend, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, write, type, listen and hear.
• Must be able to work some weekends and extended hours based on as needed and required.
• Must be willing to work any shift or site as required.
• Able to be able to wear personal protective equipment (PPE) such as hard hat, hair net, safety shoes, glasses, lab coat, and other PPE as required.
• No remote work.
• No employment sponsorship.
• No relocation.