Technician

Job Title: Technician
Location: Berkeley, CA
Zip Code: 94710
Start Date: ASAP
Job Type: Contract
Keywords: #Technicianjobs

JOB RESPONSIBILITIES:
Cell Culture bioreactor system assembly and use, including control of gas supply to
bioreactor, Micro-sparger assembly, Anti-Foam Emulsion system. Ability to
troubleshoot and control processes.
o Continuous Cells Separation equipment preparation and process/controls.
o Membrane Absorption Chromatography process (e.g. Membrane Absorption process,
Buffer and NaOH supply, cTCF supply, Capsule preparation, Inline dilution and
Temperature controls).
o Basic knowledge of protein chemistry and purification systems such as anion, cation,
and immunoaffinity chromatography.
o Membrane Absorber technology, viral removal techniques and tangential flow filtration
technology. Large scale chromatography, TFF technology.
o Familiarity with cGMP"s and applicable agency regulations

Prepares process equipment (including but not limited to Bioreactors & ancillary equipment,
Stainless Steel tanks, Pressure Transmitters, Flow Meters, Aggregate traps, Harvest
discards, Transfer lines (buffers, cTCF), Hoses and small parts.

* Cleans and Sterilizes equipment using appropriate CIP (Clean-In-Place), SIP (Steam-In*Place) procedures.
* Performs daily or routine process operations in the cell culture and purification of biotech
and biological products (Kovaltry, Kogenate, and Jivi). Operates equipment for these
processes including:
o Inoculates and monitors bioreactors.
o Processes cTCF material to Continuous Cell Separation (CCS).
o Operates Chromatography, MAEF, MAVF and TFF skids.
o Processes MAEF material using closed thaw process, step elution chromatography,
Membrane Absorber and filter clearance technology, and gradient controlled SP column
separation techniques.
o Operates 50L, 200L and 1000L collection bag technology to ensure robust collection,
mixing and dilution of products.
o Performs PEGylation of JIVI in process material using TFF technology.
o Operates automated bagging systems.
o Blast Freezes product for storage.
o Dispenses chemicals and formulate solutions.
o Prepares acids and bases as necessary.
* Performs aseptic operations.
* Takes, analyzes and submits samples as required throughout the process.
* Monitors and controls operation with computer control systems.
* Completes all routine check sheets.
* Cleans equipment and maintains clean and orderly production facilities.
* Performs in-depth troubleshooting and root cause analysis of Kovaltry, Kogenate, and Jivi
equipment and process failures.
* Contributes to continuous improvement opportunities.
* Performs all operations in compliance with cGMP.
* Performs other related duties as assigned.
Qualifications & Competencies:
Required Qualifications:
* Requires completion of two-years" college science courses in (e.g. biology, chemistry,
biochemistry, or microbiology) or a certificate from an accredited bio-technology academy.
* Relevant bio-tech industry experience in some or all of the following is preferred, and may
be considered in lieu of some or all of the educational requirements above

Intake Questions:
* Give me an overview of the role: What is a day like in this role? From a candidate"s perspective, what"s exciting about this role and team? What does this role accomplish for the business.
1. The detailed description in the posting tells the day"s activities
Prepares process equipment (including but not limited to Bioreactors & ancillary equipment,
Stainless Steel tanks, Pressure Transmitters, Flow Meters, Aggregate traps, Harvest
discards, Transfer lines (buffers, cTCF), Hoses and small parts.

* Cleans and Sterilizes equipment using appropriate CIP (Clean-In-Place), SIP (Steam-In*Place) procedures.
* Performs daily or routine process operations in the cell culture and purification of biotech
and biological products (Kovaltry, Kogenate, and Jivi). Operates equipment for these
processes including:
o Inoculates and monitors bioreactors.
o Processes cTCF material to Continuous Cell Separation (CCS).
o Operates Chromatography, MAEF, MAVF and TFF skids.
o Processes MAEF material using closed thaw process, step elution chromatography,
Membrane Absorber and filter clearance technology, and gradient controlled SP column
separation techniques.
o Operates 50L, 200L and 1000L collection bag technology to ensure robust collection,
mixing and dilution of products.
o Performs PEGylation of JIVI in process material using TFF technology.
o Operates automated bagging systems.
o Blast Freezes product for storage.
o Dispenses chemicals and formulate solutions.
o Prepares acids and bases as necessary.
* Performs aseptic operations.
* Takes, analyzes and submits samples as required throughout the process.
* Monitors and controls operation with computer control systems.
* Completes all routine check sheets.
* Cleans equipment and maintains clean and orderly production facilities.
* Performs in-depth troubleshooting and root cause analysis of Kovaltry, Kogenate, and Jivi
equipment and process failures.
* Contributes to continuous improvement opportunities.
* Performs all operations in compliance with cGMP.
* Performs other related duties as assigned.

2. Assist with the manufacturing of licensed, commercial sterile product in an aseptic environment utilizing computer operated equipment. Manufacturing includes facility and equipment cleaning, aseptic filling, lyophilizing, capping, preparing and sterilizing assemblies, tanks, and other various types of equipment, and supporting buffer formulation and the sterile bulking process.
a. The primary responsibilities of this role are to:
b. Focus on preparing and sterilizing assemblies, tanks and other various type of equipment, and supporting buffer formulation and the sterile bulking process

3. Preparation and transfer of Cell Culture and Purification large scale solutions, and filtration of Media solutions including but not limited to: antifoam, metals panel, and stabilizer solution.
a. Cleans/sterilizes and maintain Media/Solution Prep equipment using appropriate CIP (Clean-In-Place), SIP (Steam-In-Place) procedures, including manual cleaning of buffer tank interiors.
b. Preparation of various equipment for processing, for Autoclave
c. Weigh out chemical kits for Media and solutions.
d. Operate Automated HCL distribution system, drum lifter for addition of chemicals to solution prep tanks, and Osmolality, pH, Conductivity, and Refractive Index meters.
e. Perform manual bagging process for cell culture solution.
f. In-process sampling for Media and EMO sampling.
g. Monitor and control operation with computer control systems.
h. Perform aseptic operations.
i. Perform in-depth analysis of problems and contributes to continuous improvement opportunities.
j. Perform other related duties as assigned.

* Who will this person work with on a daily basis? Different qualified operators in each area, on average 6 FTEs a day
* Why is this role open? Is this more maintenance or new development work? Increased workload for production
* Location of this role (Onsite, Hybrid, Remote)? All onsite
* Tell me about the team dynamic/culture - long standing team that has worked together for years or fairly new team? How does the team work together? All teams have ops who have been here 15+ years with a great working culture
* What is the long term plan for the role? Conversion potential? Potential extension or conversion depending upon the business need post 6 months
* What does the ideal candidate background look like (ex: pharmaceutical specific background specific industry experience etc.)? Someone who worked in the field before and understands cGMP rules. It can be taught but ideally we want someone who has an idea with great work ethic and team work.
* What are you not interested in seeing and why? Someone who has bounced around from job to job, it shows they are not stable
* What kind of soft skills are you looking for? Communication, MS programs, computer skills, and written skills
* Are you open to candidates relocating (on their own) or do you prefer local candidates? Prefer local candidates
* What is the highest level of education is needed for this position? High school diploma
* Any certifications required for this role? no
* Hours per week? Any chance of OT? Shift start time? 40 hours per week. Potential for OT. Shift start times are as follows : 6am - 2:30pm, 6pm-2:30 am, 6:30am-3pm, 2:30pm-11pm, 10:30pm-7am,
* Any driving required? If so, what are they driving? How often? none
* Any travel required? If so, where? How often? none
* What is the typical work environment? Will they be required any PPE? If so, is it provided ? Scrubs, safety shoes, and safety glasses all to be provided
* Standard Dress Code? Standard street clothing, will be in scrubs primarily
* How have you filled these Requisitions in the past? yes - through Fieldglass
* Will you plan on interviewing these candidates? Interview process? Who from the team will be involved? Phone screen or face-to-face? Stress the importance of moving quickly - if we can avoid more than 1 interview per candidate, that will get someone in the door quicker. Yes interview will be done on teams (video chat lasting roughly 45 min)
* Will there be training for these roles? If so, when will the training be completed and how long will it be? Paid Training? Yes training is ongoing will focus 2 weeks on basics
* Timing for making an offer? Use this question as a discussion point about how quickly good candidates are off the market. ASAP

If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/Disability/Veterans