Cell Therapy Specialist I*

TekWissen LLC

Frederick, MD

JOB DETAILS
SALARY
$28–$31
SKILLS
Biology, Biotech and Pharmaceutical, Cancer, Change Control, Current Good Manufacturing Practice (cGMP), Diversity, Drug Development, GMP (Good Manufacturing Practices), HIV/AIDS (Acquired Immune Deficiency Syndrome), Hepatitis B, Hepatitis C, High School Diploma, Identify Issues, Maintain Compliance, Manufacturing, Materials Management, Operational Support, Quality Assurance, Quality Control, Regulatory Compliance, Research & Development (R&D), Standard Operating Procedures (SOP), Team Player, Workforce Management
LOCATION
Frederick, MD
POSTED
11 days ago
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: Cell Therapy Specialist I
Location: Frederick, MD
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: 6:00 am to 4:30 pm (Day Shift), Sun-Wed, Wed-Sat, and Thurs-Sun
3:00 pm to 1:30 am (Swing Shift), Sun-Wed, Wed-Sat, and Thurs-Sun
5:00 pm to 3:30 am (Swing Shift), Sun-Wed, Wed-Sat, and Thurs-Sun
Job Description:
  • Everyone at this facility is grounded by one common goal curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
  • Would you like to join us in this mission?
  • We are seeking a highly motivated, Cell Therapy Specialist to join our newly formed Cell Therapy Manufacturing team at our brand new, state of the art, commercial Cell Therapy facility in Frederick, Maryland.
  • The Cell Therapy Specialist will perform and/or verify all tasks associated with the manufacture of commercial product following batch records and standard operating procedures (SOPs) to ensure safe and compliant operations as well as works as part of a team to execute GMP runs in close collaboration with Materials Management, Quality Control and Quality Assurance.
Responsibilities (include but are not limited to):
  • To be considered for this role, you must meet the following basic criteria:
  • Successfully troubleshoots processing and equipment issues while communicating said issues to management
  • Completes required training assignments to maintain necessary technical skills and knowledge and to ensure compliance with cGMP requirements
  • Authors and/or revises SOPs that are technically sound, provides clear instructions to align with cGMP requirements, and supports efficient operations
  • Routinely monitors, cleans, prepares and operates sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean rooms. All required PPE and gowning for classified GMP manufacturing areas are provided by the company.
  • Finds opportunities for improvement in manufacturing efficiencies and compliance while assisting with investigations/deviations and change controls
  • Ability to wear a respirator during use of certain cleaning chemicals
Basic Qualifications:
  • Bachelor s Degree in Life Sciences Field
  • Associates Degree in Life Sciences Field with 1+ years of biotech experience or
  • High School Diploma with 2+ years of cGMP experience
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/