The Senior Manufacturing Associate performs routine and complex operations for the GMP production of pharmaceutical products. This individual exhibits model behaviors in accordance with environmental, health, safety, and cGMP guidelines.  This individual is responsible for the hands on execution of production activities as they relate to spray drying, capsule filling, and blister packaging operations of manufactured products. This individual works closely with the Engineering group to scale-up and troubleshoot manufacturing processes, and may perform maintenance of manufacturing equipment.

_*_ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Executes routine and complex production processes, and provides guidance manufacturing staff for activities relating to:
  • CIP/SIP operations
  • Component/Equipment Preparation
  • Spray Drying
  • Capsule Filling
  • Packaging
• Performs set up and teardown of manufacturing equipment utilized in production processes.
• Coordinates the ordering of raw materials used in the production processes with Materials Management.
• Drives safety and process improvement initiatives with manufacturing staff.
• Collaborates with support functions for the execution of engineering and development protocols, and CAPA implementation.
• Provides guidance and training to less experienced team members on manufacturing processes.
• Develops and implements Standard Operating Procedures (SOPs) for manufacturing related processes.
• Performs product and process investigations and documents findings in accordance with the deviation program.

SUPERVISORY RESPONSIBILITIES:   None. However, this individual may occasionally act as a team lead and may coordinate activities of manufacturing personnel. 

EDUCATION AND/OR EXPERIENCE:

• High school diploma with a minimum of 8 years relevant bio-manufacturing experience required.
• Biotechnology Certificate from an accredited institution and/or an Associate’s degree in a science related or engineering field, with a minimum of 5-8 years of related experience preferred.
• Bachelor’s degree in a science related or engineering field, and a minimum 3-5 years of related experience preferred.

QUALIFICATIONS:

• Extensive experience with operating automated manufacturing control systems, utilizing parts washers and autoclaves for the preparation of manufacturing and/or laboratory equipment.
• Critical understanding of the importance of documentation and data traceability.
• Strong working knowledge of Good Documentation and current Good Manufacturing Practices required.
• Experience with the revision and review of Standard Operating Procedures and Batch/Production Records in a manufacturing, preferably in the pharmaceutical industry.
• Demonstrated experience to perform product and/or process investigations.
• Demonstrated experience to train and develop employees in a manufacturing environment.

CERTIFICATES, LICENSES, REGISTRATIONS: None required.

COMPUTER SKILLS:

• Must be proficient in MS Office Suite.
• Experience with automated manufacturing control systems required.

OTHER SKILLS AND ABILITIES:

• Demonstrates attention to detail.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities at one time and adjust priorities as necessary.
• Ability to manage both day-to-day operations as well as project work in a fast paced environment.
• Excellent organizational skills.
• Must be able to work well independently and in a team environment.

PHYSICAL DEMANDS:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Must have the ability to lift up to 50 pounds.
• Requires physical activity such as standing for long periods of time, walking, and working with hands.
• This position requires minimum travel. Average travel for this position is less than 5% with some variation based upon the demands of business imperatives.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• Must be able to work in a controlled or clean room environment requiring special gowning.
• Must have the ability to work safely and conscientiously in a manufacturing environment.
• Some weekends or holidays may be required.
• May require adjustment to a shift schedule as manufacturing objectives change.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.