Manufacturing Technician 4

Job description

Manufacturing Technician 4

Your Role:

The Manufacturing Technician 4 position will be the primary coordination point for GMP Manufacturing of biologics at the Carlsbad site.  These positions may have supervisory responsibility.  Employees will support projects in conjunction with other GMP Manufacturing personnel (Supervisors, Managers).  Tech 4 roles will assume decision-making authority as delegated by management and can include interaction with clients.  Employees are expected to prepare suites for manufacturing, to prepare and autoclave tubing assemblies, and to operate in a safe manner for the employee, others in the GMP Manufacturing suites, and for the inspection and labeling of Final Product being manufactured. The employee must be able to work off-shifts, weekends, and additional hours as required. The employee must have the ability to perform moderately physical activity. The employee must have the ability to perform very complex tasks with attention to detail. The employee must be self-motivated, work well in a group, and communicate well with all levels of the operations team.

 

Who You Are:

 

Minimum Qualifications:

·  Bachelor of Science degree OR HS Diploma/GED AND 4+ years’ work experience in a cGMP clean room environment performing aseptic manufacturing operations
·  4 + years of experience in either upstream and/or downstream in aseptic manufacturing operations
·  4+ years’ experience working with cGMP/GDP concepts
·  4+ years’ experience with sterile cell culture and aseptic operations in a BSC/LFH (bio safety cabinet, laminar flow hood)
·  4+ years knowledge of biology and chemistry
·  4+ years’ experience basic troubleshooting of cell culture systems
·  4+ years’ experience compliance with safety guidelines
·  3+ years’ experience drafting and revising Standard Operating Procedures or Batch Records
·  2+ years’ experience working knowledge of desktop computers and technical equipment (MS Office)

 

Preferred Qualifications:

·  Experience with vial thaw and flask expansion operations
·  Disposable bioreactors (25 to 100L, Wave, SUB, iCELLis), viral vector manufacturing experience preferred
·  Experience growing adherent cultures in a T-Flasks, CellSTACKs and/or HYPERstacks
·  Tangential flow filtration (UF/DF) with hollow fiber membranes
·  Sterile filtration of media, buffers, and drug product
·  Experience with GE AKTA Purification Skid operation / column chromatography / column packing preferred
·  Media and buffer preparation
·  Experience in semi-automated filling and finishing final product

RSRMS

Job Requisition ID: 202356

Location: California - all

Career Level: D - Professional (4-9 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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