Manufacturing Associate

At a top Biopharmaceutical company, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manufacturing Associate at our Thousand Oaks, CA site. Here, you will be a vital contributor to our inspiring, bold mission, and have the opportunity to grow within a thriving company.

Summary:

The Manufacturing Associate is provided 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 all in the Drug Product (Formulation/Filling) team. This is a perfect entry level position for those with minimal experience or want to gain further career advancements within the Biotech industry!

Title: Manufacturing Associate I/II

Location: Los Angeles, CA - Onsite

Pay: $23-$25/hr.

Duration: 12 months w/ potential for extension

Shifts: Wed-Sat 12PM – 10:30PM (OT after 8 hours of work)

Responsibilities:

• 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.
• May perform other duties as assigned.
• Set up operations, daily maintenance, and breakdown 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.

Must Haves:

• 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.
• Actively seeks opportunities for personal growth and development and monitors progress toward achieving development goals.
• Excellent organizational, interpersonal, verbal, and written communication skills
• Proactively assists others in accomplishing work.
• Listens carefully and is receptive to feedback from others.
• General knowledge with cGMP manufacturing, regulatory regulations and requirements is a plus.

Education/Experience:

• High school diploma or equivalent required; bachelor’s degree preferred.
• No minimum years of experience required; 1-2 years preferred.

Work Environment:

• 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 be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
• 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 manufacturing such as IPA, 500ppm sodium hypochlorite.
• Able to work in controlled or clean room environments requiring special gowning.
• May require the use of special visual or auditory protective equipment.
• 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 waste in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, and generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
• May be required to work overtime, a weekend day, holidays or be assigned to a different shift.
• May work and have exposure to hot, cold, wet environment/conditions.
• May be required to work in confined areas; may be required to work around moving equipment and machinery.
• May be required to work at heights above floor level.
• May be required to climb (use step stools and ladders) or kneel up to 1 hour.
• May be required to walk, stand, or bend at the neck/waist for over 4 hours
• May be required to reach above/below the shoulder between 3-4 hours
• 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.