Job Details
BioTalent are partnered with an exciting Cell Therapy Company in Boston to search for Senior Manufacturing Technicians to join their team.
Under Manufacturing management guidance, the Senior Manufacturing Technician is responsible for oversight of manufacturing activities in the cleanroom for cell therapy products meeting internal and regulatory requirements.
ESSENTIAL FUNCTIONS
Core Responsibilities:
- Perform aseptic manufacturing procedures inside an ISO Class 7 cleanroom in accordance to established SOPs, cGMPs, and Safety regulations.
- Maintain frequent communication with Supervisor to exchange information, recommendations and to review daily cleanroom activities.
- Under Management guidance, provide consistent, ethical and responsible leadership to manufacturing teams to meet production demands.
- Provide guidance to staff consistent with cGMP and corporate quality governance.
- Serve as a liaison between employees and Management.
- Observe for process consistency within the team and report any observations to Management when problems occur. Receive guidance from Management regarding remediation.
- Serve as a technical resource for questions and/or investigate manufacturing issues.
To be successful in this Application you will bring:
- 2+ years of experience working in a cGMP environment in the biotech or pharmaceutical industry.
- Experience working with mammalian cell culture would be highly desirable.
- Must possess solid working knowledge of MS Office (Word/Excel/PowerPoint).
Preferred Qualifications:
- Bachelor s Degree (Life Sciences or related field) or equivalent
- Experience within a regulated environment that is frequently audited by FDA, ISO and other internal and external Agencies.
- Qualified as an On the Job Trainer.
- Excellent communication skills, written and verbal.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- May be required to sit for long periods of time while performing cell culture operations.
- Must be able to lift, carry, push and pull up to 50 lbs.
- Ability to work 1 weekend day.
- Rotating holiday coverage.
- Ability to gown and gain entry to manufacturing areas