Manufacturing Associate

Overview:

The Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.

External US:

Manufacturing Associate

Position Summary: The Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production.

Location: Thousand Oaks, CA

Primary Responsibilities:

• Performs Aseptic operations in a Grade A environment
• Support production in an aseptic environment.
• Executes on production batch records and work orders according to SOPs and protocols.
• Generates work orders.
• Assist in all areas of cell culture and all related duties as required including (stocking, tracking inventory, material movement, maintaining metrics, filling out log sheets, and other special projects).
• Assists in manufacturing batch record review.
• Initiates deviations and participates in root cause investigations and CAPA.
• Drafts and revises SOPs/ WINs/ BRs.
• Execute SAP transactions.
• Execute media batching.
• Routine maintenance and cleaning of rooms and equipment.
• Identifies and implements continuous improvements.
• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements.
• Adhere to all safety protocols and procedures.
• Execute visual inspection of final drug product.
• Will be managing D space during production (sample handoff, material ingress as needed, print documents as needed).

Position Requirements:

• cGMP knowledge
• Basic knowledge of aseptic processing
• Basic knowledge of cell culture (preferred)
• Ability to follow verbal and written instructions
• Problem Solving skills
• Detail oriented
• Team player
• Strong communication skills
• Strong demonstrated aseptic techniques

Education & Experience:

• Bachelor of Science (B.Sc.) with 0-3 years of experience; or
• Associate degree with 2+ years of experience; or
• High school diploma with 3+ years of experience

Physical Requirements:

• Work is generally performed in a GMP manufacturing facility.
• Subject to extended periods of standing (8 hours).
• The position requires a combination of standing in the manufacturing environment. and walking around the facility.
• Will required weekend and some holiday work.
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.

Travel:

• Possible 10%

Salary and Benefits:

• $26.50 to $33.50 per hour, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.