Job Description

POSITION OVERVIEW

**This is a M-F position 1ST SHIFT POSITION supporting the MSAT pilot plant**

The Manufacturing department is where the biologic drug substance is produced and purified  in appropriate bio processing equipment.  The Global MSAT department develops second generation processes, owns control strategy and drives scale-up and tech transfer of the DS manufacturing process to Manufacturing.

This is a position within the 8 NYA Manufacturing Organization who will work directly with members of the Manufacturing Science and Technology (MSAT) Pilot Plant team to support 2nd generation pilot plant runs.  

As a member of the 8 NYA Manufacturing team, the person in this role will be embedded within the MSAT Pilot Plant, working together with the 45 NYA Pilot team who are responsible to perform scale-up development and establish robust operable 2nd generation processes. Through direct hands-on effort on operability aspects by the manufacturing expert early in the scale-up development cycle together with MSAT Pilot team, the implementation of 2nd generation processes in the 8 NYA facility is expected to be seamless. Also, she/he will become process owners of relevant steps for daily process management in manufacturing upon implementation.

This is a M-F position supporting the MSAT pilot plant with the focus of this role being on the downstream steps of the 2nd generations products. 

There will be some cross over to support the cell culture processes also performed in the Pilot Plant.  The individual in this role will be responsible for executing 2nd generation processes in the MSAT Pilot Plant, providing process operability input, and developing process automation for use in the GMP facility.  This individual will be responsible for transferring the skills, knowledge, and procedures to 8 NYA staff for successful commercial execution.

Key Responsibilities will involve the following:

Ability to work safely in a pilot plant environment, set an example and expectation for work by teammates, and maintain a safe work environment.

Ability to work collaboratively with MSAT personnel and Manufacturing personnel supporting 45 NYA and 8 NYA, providing process input when needed

Operate as primary individual responsible for the execution of 2nd generation downstream processes.

Application of scaled down processes to commercial scale operations at 8 NYA.

Ability to develop and optimize operational procedures for use in 8 NYA GMP operations.

Application of 2nd generation processes into the existing automation framework used in commercial manufacturing.

Opportunistic individual who is willing to work to develop a process with future transfer to GMP Manufacturing environment.

Experience and strong understanding and focus on upstream processing/manufacturing.

Individual with flexibility and ability to execute in a various work streams – downstream, buffer prep, and additional support of  cell expansion, bioreactors, media prep.

Ability to operate MSAT equipment and identify elements that need to be addressed to implement in a manufacturing environment (8 NYA) and lead resolution where needed.

Able to communicate clearly and confidently.  Ability to communicate clearly with management as needed.

Ability to effectively train 8 NYA staff on Cz2G process/procedures.

Able to work in a non-GMP environment with a view toward a seamless transition to a GMP environment.  

Contribute to troubleshooting during scale-up development studies and lead investigation and defining improvement solutions for operability issues.

Participation as a representative for Manufacturing in daily SCRUM board and other SMS tools utilized in Global MSAT.

Will act as manufacturing representative for the transfer of the cell culture process and supporting operation from 45NYA pilot facility to Manufacturing, conveying the aspects of manufacturability and facility fit of the process.

Contribute to process robustness and operability improvement studies in MSAT lab together with MSAT personnel at bench (2L) and pilot (50L) scales.

Promotes "Right First Time" philosophy for all activities.

Manages or supports plant floor continuous improvement initiatives.

Represents Manufacturing in Project Team meetings; may lead department initiatives and projects.

Leadership Qualifications:

Working a matrix environment with ability to Act for change and Make decisions.

Acting as role models for our fellow employees by acting responsibly, fairly, honestly in our dealing and exercising sound judgment in performing our jobs.

Basic Qualifications:

High School diploma/GED with 6-10 years of experience in a cGXP environment OR

Bachelor's degree with 4-8 years of experience AND

1 year in a lead or supervisor role.

Must have prior experience in cGMP manufacturing operations.

Demonstrated ability to effectively coach and train employees.

Preferred Qualifications:

Bachelor's degree with 5-9 years of experience in bulk biologics GMP manufacturing AND 2+ years of experience leading manufacturing teams.

Knowledge of and experience executing downstream/purification processes in a GMP manufacturing environment.

Experience authoring and reviewing standard operating procedures, on the job training, and other controlled documents.

Effectively uses process automation systems to operate production processes (ie. DeltaV, MES)

Demonstrate good technical writing skills, strong troubleshooting skills, and be familiar with biologics regulations.

Experience reviewing and creating controlled documents

Special Working Conditions:

Ability to lift up to 40 lbs.

Ability to stand for 6 hours in a production suite

Ability to gown and gain entry to manufacturing areas

Large scale operation (500L bags, handling 1000s of liters of media and waste),

Weekend coverage and holiday coverage