Biotech Manufacturing Associate I / Cell Culture:
Actalent

1567998004
Actalent
Thousand Oaks California
Biotech
Apply
Description
Description:

Under the general direction of the Manufacturing Lead and overall direction of the Supervisor, the Manufacturing Associate is responsible for executing all processes in the production area while strictly adhering to CGMP, environmental health and safety guidelines and any other related regulations. Drug Substance - Cell Culture/Purification: • Support Cell Culture/Purification operations to produce a bulk drug substance product. • Prepare media and buffer solution. • Clean, set up, operate, and teardown of equipment such as tanks, filtration systems, carton assembler, bioreactors, and production lines. • Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.). • Monitor and record critical process parameters. • Complete relevant paperwork following GDP/GMP guidelines. • Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion. • Manually clean portable equipment and small parts. • Perform sampling using aseptic techniques. • Participate on Continuous Improvement Teams. • Receive and distribute supplies into production area as necessary. Drug Product - Formulation/Filling: • Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations • Executes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply • Clean, set up, operate, and teardown of equipment such as, tanks, filtration systems, filling lines, lyophilizers, etc. • Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, etc. • Receive and distribute supplies into the manufacturing areas. All Areas • Set up operations, daily maintenance, and break down of simple/routine equipment. • Gain qualification to perform CIP, SIP autoclave, small parts preparation. • Identify processing gaps and assist with implementation of new technologies. • Perform minor to moderate troubleshooting • Draft simple to moderate DCRs and complete minor NCR investigations. • May perform other duties as assigned. • Highly motivated, proactive, and enthusiastic team player with demonstrated history of flexibility • Ability to work independently, collaborate cross-functionally, and utilize resources efficiently • Ability to troubleshoot, demonstrate problem solving skills, and multitask while paying attention to timelines and priorities • Able to work effectively and efficiently in a team environment. • Able to provide feedback for operations & elevate concerns as needed • Excellent organizational, interpersonal, verbal, and written communication skills • Proactively assists others in accomplishing work • Listens carefully and is receptive to feedback from others. • High school diploma or equivalent required; Bachelor's degree preferred • 0-2 years of related work experience. • General knowledge with CGMP manufacturing, regulatory regulations and requirements is preferred • The overall physical exertion of this position requires medium to heavy work. • May be required to gown frequently and balance when gowning into clean areas. • May require the use of special visual or auditory protective equipment. • May be required to work at heights above floor level. • Will not be required to operate foot controls or repetitive foot movement. • May be required to sit between 1-2 hours. • May be required to climb (use step stools and ladders) or kneel up to 1 hour. • Requires repetitive use of both right and left hands and arms up to 3-4 hours. Cell Culture/Purification • May be required to walk or stand between 3-4 hours. • May be required to bend at the neck/waist or squat for up to 1 hour in Bulk and between 1-2 hours in Suite A. • May be required to reach above/below the shoulder between 1-2 hours • May be required to twist at the waist up/twist at the neck up to 1 hour • May be required to lift up to 75lbs in Bulk and over 75lbs in the Suite A area; Lifts per shift up to 14 times. • May be required to carry up to 25lbs; Carry distance of up to 30ft; Carries per shift up to 6 times in Bulk and up to 14 times in Suite A. • May require simple grasping/power grasping and fine manipulation up to 1 hour • May require pushing/pulling with hands/arms between 1-2 hours. • May require office work activities with hands/arms up to 1 hour in Bulk; between 1-2 hours in Suite A. Formulation/Filling • May be required to walk, stand or bend at the neck/waist for over 4 hours • May be required to squat between 1-2 hours • May be required to reach above/below the shoulder between 3-4 hours • May be required to twist at the waist up/twist at the neck up to 1 hour • May be required to lift up to 50lbs; Lifts per shift are up to 100 times. • May be required to carry up to 50lbs; Carry distance of up to 6 feet; Carries per shift are up to 100 times. • May require simple grasping & pushing/pulling with hands/arms between 3-4 hours; power grasping for over 4 hours; fine manipulation between 1-2 hours. • May be required to work with biohazards such as: bloodborne pathogens or medical waste. • Will require entering a 2-8 degree Celsius & -60-degree Celsius freezer to store and retrieve materials and various chemicals in support of mfg such as IPA, 500ppm sodium hypochlorite. • Must be able to work in controlled or clean room environments requiring special gowning. • Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments. • May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling and on-site transporting of hazardous wastes. • May work and have exposure to hot, cold, wet environment/conditions • May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection. • May be required to work in confined areas; may be required to work around moving equipment and machinery • May require office work activities between 1-2 hours. • This position requires overtime, weekend, and holiday work. • May be required to work or be assigned to a different shift as needed.

Skills:

GMP, Media prep, buffer prep, cell culture, protein purification, ncr, drug substance

Top Skills Details:

GMP,Media prep,buffer prep

Additional Skills & Qualifications:

Bachelors preferred, High School diploma with GMP MFG experience also ok

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.