Operations Gowning Trainer

Initial Therapeutics, Inc.; Raritan (NJ); On-site; USD 59,168 - 77,658; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) match

Paid parental leave

Flexible spending accounts

Job summary

Initial Therapeutics, Inc. is seeking a Gowning Training Specialist in Raritan, New Jersey. This role involves conducting gowning training in a cGMP environment, ensuring compliance with quality and safety regulations. Responsibilities include executing training programs and maintaining documentation per company policies. Ideal candidates should have a history in Biotech or Pharmaceutical sectors.

The position offers competitive pay and a comprehensive benefits package including medical and dental insurance, 401(k) with matching, paid parental leave, and more.

Qualifications

• HS Diploma with 4-6 years Biotech/Pharmaceutical experience or Bachelor's degree required in Life Sciences or Engineering with 0-2 years experience.
• Ability to communicate and follow written, oral, and diagram instructions.
• Knowledge and ability to operate manufacturing and lab equipment.

Responsibilities

• Support the Gowning Training Program in a cGMP environment.
• Execute Instructor Led Trainings and qualifications for personnel.
• Perform gowning training and execute tasks per SOP and GDP.
• Ensure safety standards and cleanliness are maintained in work environment.

Skills

Biotech/Pharmaceutical experience

Knowledge of Process Excellence Tools

Ability to operate manufacturing equipment

Good communication skills

Problem-solving skills

Education

HS Diploma with 4-6 years experience or Bachelor's in Life Sciences/Engineering

Tools

Manufacturing and lab equipment

Job description

Role Overview

This position is responsible for performing manufacturing gowning training and the execution of gowning training tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.

Key Responsibilities

• Support the Gowning Training Program responsible for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
• Execute Instructor Led Trainings (ILT), Qualifications, and Requalification of Raritan CAR-T Personnel.
• Execute manufacturing gowning activities to support cell culturing, purification, aseptic processing, and cryopreservation using appropriate gowning techniques.
• Perform gowning training and execution that follows standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).
• Perform tasks on time in a manner consistent with quality systems, cGMP, and Learning Management System (LMS) requirements.
• Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Aid in the development of manufacturing gowning processes including appropriate documentation.
• Drive continuous improvement of gowning techniques and processes leveraging own observation as well as input of team members.
• Support schedule adjustments to meet production and business needs.
• Accurately complete documentation in SOP’s, logbooks, GMP documents, and training events.
• Demonstrate training progression through assigned curriculum.
• Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
• Wear the appropriate PPE when working in manufacturing and other hazardous working environments.
• Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
• Ensure materials are available for qualifications and training.
• Support the ongoing production schedule by:
  • Report to work on-time and according to the shift schedule.
  • Perform other duties as assigned.
  • Attend departmental and other scheduled meetings.
  • Practice good interpersonal and communication skills.
  • Demonstrate positive team-oriented approach in the daily execution of procedures.
  • Promote and work within a team environment.
  • Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
  • Support investigation efforts as required.
  • Responsible for audit preparation and participation.

Requirements

• HS Diploma required with 4-6 Years Biotech/Pharmaceutical experience or equivalent industry experience OR Bachelors degree required in Life Sciences or Engineering, with 0-2 years Biotech/Pharmaceutical experience or equivalent industry experience.
• Interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Follow instructions.
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment.
• Knowledge of Process Excellence Tools.
• Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
• Is frequently required to communicate with coworkers.
• While performing the duties of this job, the employee is regularly required to stand, walk, climb, bend and stop, and reach with hands and arms.
• Ability to lift 25 lbs.
• Needs to perform gowning procedures to work in manufacturing core.

Benefits and Paid Time Off

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. Eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Pay Range (Base Pay): $59,168 - $77,658 USD

Note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.