Job Description:

• The Training & Development Associate Specialist is responsible for the successful implementation of the site Manufacturing Training Program.

• They assist in determining training solutions that adhere to the Site Training Program.

• This position trains other staff members, as well as assesses their ability to perform tasks proficiently.

• This position may also perform cleanroom processing duties as a Manufacturing Associate as needed.

Required Competencies:

Knowledge, Skills, and Abilities:

• Requires a high level of understanding of cell therapy processes, controls, and GMP requirements.

• Intermediate skills in design, development, and implementation of training.

• Ability to work in an aseptic environment requiring successful completion of qualification program.

Education and Experience:

• Preferred B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 1-3 years of relevant experience in a clinical laboratory or blood/cell culture processing environment.

Duties and Responsibilities:

• Implements training programs that meet regulatory requirements & business needs 

• Implements the local Manufacturing Operations new hire Training Program 

• Maintain the Training Laboratory and equipment for cleanliness and compliance.

• Manufacture clinical grade cellular therapeutic products to supply the Clinical Program (as needed):

• Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.

• Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.

• Reports and initiates non-conformances and participates in follow up investigation when necessary.

Working Conditions (US Only):

• Ability to perform frequent physical tasks with strength and mobility.

• Daily tasks call for extensive walking, standing and occasional lifting of heavy materials.

• Frequent visual demands require macroscopic and microscopic observations.

• Employees must work in areas where posted Universal Precautions must be observed and practiced.

• Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Minal Mishra    

Email ID: minalm@askconsulting.com

Phone: 470-730-2305