Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Technical Operations 3.

ABOUT INCLUSIVELY:

Inclusively is a digital tech platform that connects candidates with disabilities, who may benefit from workplace accommodations, to inclusive employers. This includes all disabilities under the ADA, including mental health conditions (e.g. anxiety, depression, PTSD), chronic illnesses (e.g. diabetes, Long COVID), and neurodivergence (e.g. autism, ADHD). Applicants with one or more of these conditions are encouraged to apply; Inclusively does not require applicants to disclose their specific disability.

ROLE SUMMARY

The Technical Operator III will be responsible for performing all aspects of biologics upstream and downstream production in a single use facility, including cell vial thaw and flask expansion inside a Bio-Safety Cabinet (BSC), operation of wave/STR bioreactors up to 2000L, chromatography systems, and TFF systems.

ROLE RESPONSIBILITIES

• Performs manufacturing activities per current Good Manufacturing Practices (cGMPs).
• Perform all aspects of biologics upstream and downstream production.
• Operate production equipment safely in accordance with established standard operating procedures.
• Conduct activities in support of production schedules as directed by leadership.
• Support multiple projects simultaneously.
• Review SOPs, master batch records, specifications, and other applicable cGMP documentation for Manufacturing.
• Maintain GMP records to comply with regulatory requirements and assist with in-process testing.
• Ensure compliance to training on an activity prior to GMP execution.
• Review completed batch records daily for GMP compliance and completeness.
• Inventory manufacturing supplies and ensure items are properly stocked.
• Operate to the highest ethical and moral standards.
• Adhere to quality standards set by regulations and policies, procedures, and mission.
• Work effectively in a team environment.

BASIC QUALIFICATIONS

• High School Diploma/GED.
• 4 - 6 years of experience in a GMP pharmaceutical or biotech environment of which 2 years of experience in Upstream or Downstream processing or combined education and experience.
• Good written and communication skills.
• Ability to follow detailed instructions and to maintain accurate records.
• Working knowledge and understanding of Microsoft Office Applications.

PREFERRED QUALIFICATIONS

• Ability to successfully multitask, when required.
• Bioworks Certification.

PHYSICAL/MENTAL REQUIREMENTS

• Frequently lift and or move objects at least 30 pounds.
• Stand/walk for extended periods of time.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to work a 12-hour schedule with nights and weekends.
• Ability to travel up to 10%.

Work Location Assignment: On Premise

Relocation assistance may be available based on business needs and/or eligibility.

Job Type: Full-time

Schedule:

• 12 hour shift

Work Location: In person