Senior Manufacturing Associate

Greetings from IT Engagements…!

IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.reetings from IT Engagements

Senior Manufacturing Associate (Fulltime - USC, GC Only)

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477 (On-Site)

What You’ll Do

• As a Senior Manufacturing Associate, you will play a key role in supporting our manufacturing operations:
• Knowledge of current cGMP.
• Fulfill the operator and verifier roles in performing cell growth and manipulation procedures such as cell enrichment, cell culture, cellular product cryopreservation, cell product thaw/wash.
• Accurately perform procedures in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA.
• Adhere to ALCOAC and cGDocP requirements while accurately performing procedures and maintaining documentation in compliance with SOPs.
• Document deviations and events, notify supervisor and quality management personnel in timely manner, and assist in investigation of root cause and any required corrective actions.
• Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers.
• Ability to work productively and to participate in a highly creative and fast-paced environment.
  
  

Secondary Functions

Independently perform calculations to determine cell viability, dilutions, and cell concentrations.

• Completes all appropriate logs and trackers.
• Maintains GMP cleanliness: autoclaving, bleaching liquid waste, removing waste, general cleanliness and organization of the office and facility.
• Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
• Conducts activities to support study plans, and IQ/OQ/PQs.
• Reviews and provides assistance with change controls, WI, SOPs, study plans, reports, deviations, OOS/OOE, and CAPA’s as directed.
• Provides improvement and troubleshooting ideas and executes implementation plans.
• Performs routine equipment maintenance and troubleshooting.
• Prepares high level overviews and leads presentations, as needed.
  
  

Required Experience And Education

• Bachelor’s Degree in Biology, Biochemistry, Biotechnology or other related field.
• Four (4) to six (6) years of cell therapy manufacturing experience.
  
  

Preferred Experience And Education

• Master’s Degree in Biology, Biochemistry, Biotechnology, Healthcare Administration or other related field.
• Five (5) years of cell therapy manufacturing experience.
  
  

Competencies

• Independent Working- minimal supervision of routine tasks; limited supervision of non-standard tasks.
• Communication- clear and efficient verbal and written communication; common courtesy; regular interaction with other teams or departments; basic presentation skills and efficient presentation of own work to small groups or own team
• Problem Solving- ability to identify, deeply analyze and communicate problems; advanced ability to develop and pro-actively propose suitable solutions.
• Critical Thinking- advanced reflection on standard and non-standard processes; identification of need and room for improvement within own or narrow scope; basic ability to anticipate future risks.
• Initiative- high degree of initiative and intrinsic motivation to exceed basic expectations of own tasks and responsibilities; pro-active contribution to development of the team structure and lab processes (beyond own tasks)
• Organizational & Prioritization Skills- intermediate organization skills required to structure own daily tasks according to predefined work packages, the manufacturing schedule and standard lab processes; good understanding of priorities within own/narrow scope; prioritization requires limited interaction with the manager.
• Coachability- actively reflect on and suggest trainings supporting professional development within or beyond current area of responsibility; high responsiveness to constructive criticism and ability to autonomously reflect on required improvements; timely implementation of suggested improvements.
• Leadership Skills, Training & Supervision- basic leadership skills required for on-the-job trainings and guidance/support of (new) team members (e.g. providing and receiving feedback, empathy, honesty, reliability); train, instruct and coordinate E level; train D & C level during onboarding.
  
  

Work Environment

• Typical office environment with moderate noise levels (~20% of work hours).
• Uses phone, computer, office equipment and supplies on a regular basis.
• cGMP clean room spaces and facilities (~80% of work hours).
• Grade A/B/C/D GMP environment with associated facility noise levels.
• Uses cleanroom phone, computer, variety of equipment and reagent/supplies.
• General unclassified laboratory spaces, as needed.
• Common laboratory equipment and noise levels.
• While performing the duties of this job, the employee routinely handles blood components and is occasionally exposed to temperatures between -196°C and 40°C, liquid nitrogen, liquid nitrogen vapor, dry ice, and carbon dioxide.
  
  

Travel required: Travel may be required between the office building and manufacturing facility on a daily basis.

Thank you

Shashank@itengagements.com