Job Description Summary

Responsible for preparation of materials to support downstream manufacturing operations in the Low Volume PPM Department. May operate specialty preparation equipment. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and accurate proportions following approved procedure. Assists with in process testing to ensure batches meet specifications. Responsible for validating processes and equipment directly related to filtration, cleaning and sterilization. Responsible for the removal and disposal of waste chemicals, solvents and acids. Identifies, troubleshoots, and resolves complex issues associated with bulking/formulation operations.

Job Description

Job Overview

            Leads and is responsible for manufacturing and assembling clinical and commercial products. Operates production equipment. Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and accurate proportions following approved procedure. Leads in-process testing to ensure batches meet specifications. Responsible for validating processes and equipment that are directly related to filtration, cleaning and sterilization. Responsible for the removal and disposal of waste chemicals, solvents and acids. Identifies, troubleshoots, and resolves complex issues associated with bulking/formulation operations. Provides additional leadership support as needed and escalates team issues as necessary.

Responsibilities and Duties

• Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients
• Leads simple analytical tests (pH, conductivity, and absorbance)
• Performs routine cleaning of processing equipment
• Handles hazardous waste as appropriate
• Leads inventory counting activities as required
• Inspects in-process parts to ensure consistent quality and remove defective product, packaging, and component material
• Responsible for ensuring timely and accurate documentation of all manufacturing activities performed
• Monitors meters, gauges, temperatures, pressures, and related controls
• Plans and controls timing of operations
• Generates reports, graphs, and other data
• Ensures accurate proportions of batches following approved procedure
• Interprets complex drawings, diagrams, charts and specifications
• Performs complex work to close tolerances, high quality and accuracy
• Makes effective decisions relative to position requirements
• Evaluates operating process equipment and implantation to ensure constant compliance with standard manufacturing practices (SMP)
• Uses independent judgment in troubleshooting and problem solving
• Develops weekly production plans coordinating resources (raw materials) and communicating relative priority to downstream parties
• Provides support to the supervisor when necessary
• Provides training support for on-boarding and/or new procedures
• Provides support on special projects
• Provides coaching to associates on day-to-day activities and performance
• Provides continuous improvement recommendations and/or solutions to support overall operational efficiency
• Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP)
• Must follow all BD housekeeping policies and procedures
• Must follow all BD safety policies and procedures
• Must be able to work overtime as required to meet BD business requirements

Qualifications

Minimum Education/Experience:

• High School with 6 years’ experience or AA science degree with 3 years’ experience

Basic Skills: (i.e. Time management skills, interpersonal skills, detail-oriented, teamwork skills, communication skills)

• Exhibit the ability to use independent judgment and demonstrated leadership
• Possess the ability to communicate (oral/written) technical and non-technical information across the group and organization
• Possess strong time management skills to complete assigned tasks in an accurate and timely manner
• Strong attention to detail

Proficient/Working Skills: (i.e. Forklift Certification, computer skills, problem solving skills)

• Must be proficient in English with the ability to read, write, analyze/evaluate charts, follow simple diagrams and perform basic arithmetic
• Demonstrate the ability to use personal computers
• Proficiency in MS Excel is required
• Must be able to use advanced math skills to produce accurate formulas
• Possess the able to read, write, comprehend and interpret complex charts, drawings, diagrams, graphs and other data
• May require forklift certification

Minimum Physical Requirements (Lifting requirements):

• Lifting/moving 1-5 lbs. over 70% of the time
• Lifting/moving 5-25 lbs. 40%-70% of the time

Working Conditions (Bending, pushing, twisting)

• Must be able to work  2nd shift from 4 pm- 2:30 am including weekends

Primary Work Location

USA MD - Baltimore

Additional Locations

Work Shift