Easter Seals Jobs

Overview

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives, and our united passion for advancing tomorrow's medicines - our Genki - will always be our driving force. While working as a Senior Manufacturing Associate with our Thousand Oaks team, you'll be joining other motivated individuals who fuel one another's passions and embrace every day as an opportunity. We am to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

External US

Manufacturing Senior Associate

Department: Internal Manufacturing

Location: Thousand Oaks, CA

Reports To: Manufacturing

The Manufacturing Senior Associate works as part of the manufacturing team to deliver high quality therapeutics. This role is focused on processing of cell therapy technologies where Aseptic Processing is of the utmost importance. This role contributes to the successful delivery of released product in support of clinical trials and commercial production.

Major Activities and Responsibilities:

• Performs Aseptic operations in a Grade A controlled environment and train staff on aseptic operation

• Support production in a controlled environment and train staff as needed

• Under minimum supervision, executes on production batch records and according to standard operating procedures and protocols

• Under minimum supervision, assist in all areas of cell processing and all related duties as required including (stocking, inventory management, material movement and reconciliation, controlled forms management, planner entry form issuance and other tasks)

• Independently support manufacturing batch record review

• Assists in the development of manufacturing electronic batch records

• Author drafts and revision of standard operating procedures, /work instructions/batch records of existing and new processes and or equipment as needed

• Support routine maintenance and cleaning of rooms and equipment

• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements

• Initiate Work orders as needed

• Independently supports initiation and investigation of minor deviations and supports root cause investigations and CAPA records

• Support as SME training of staff as applicable

• Identifies and implements continuous improvements

• Support NPI and Process Transfer activities as needed

• Execute visual inspection of final drug product.

• Will be managing D space during production (sample handoff, material ingress as needed, print documents as needed).

• Assist the team with maintaining an up-to-date working inventory for the equipment/supplies

• Document and review appropriate paperwork, daily logs, and documentation per Good Documentation Practices, to include electronic documentation

• Participate in a detailed training program and develop training plan

• Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements

Background Requirements ( Education, Behavioral, Professional & Technical Capabilities Experience):

Qualifications:

• Bachelor of Science (B.Sc.) with 3+ years of experience; or

• Associate degree with 4+ years of experience; or

• High School Diploma 5 + years of experience

• Preferred Qualifications

• Ability to follow verbal and written instructions

• Problem solving skills

• Detail oriented

• Team player

• Ability to work with minimal supervision

• Strong communication skills

• Strong demonstrated aseptic techniques

Work Environment:

• Work is generally performed in a Good Manufacturing Practice (GMP) facility. A GMP facility is governed by regulatory agencies in which there are specific requirements for hygiene and acceptable clothing. The following items are restricted when accessing the GMP manufacturing area:

• Makeup, painted nails

• Hair products (spray, gel, wax)

• Perfume and cologne

• Jewelry (rings, watches, bracelets, fitness bands, necklaces, and facial/ear

• piercings, etc.)

• Donning of gowns requires ability to physically don gowns while balancing in a cleanroom environment

• Personal Protective Equipment is required to perform certain tasks (i.e., latex/nitrile gloves, respirators and or masks, goggles, plant dedicated scrubs/shoes, full body gown that covers all exposed skin)

• Subject to extended periods of standing, to include crouching / kneeling (8 plus hours) while being donned in applicable PPE

• Required to handle biohazardous and hazardous material via direction of Standard Operating Procedures

Physical Requirements:

• Medium work that includes moving, lifting, pushing and or pulling objects up to 50 pounds

• Medium work that includes pushing and or pulling equipment with up to 50 pounds of force assisted by wheels

• Must be willing and able to bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator

• Position requires a combination of standing in the manufacturing environment and walking around the facility

• Open to work various shifts

• During initial onboarding and training – the schedule will be Monday through Friday ( 6am-2:30pm)

• After training qualification staff must be open to working any of the 4/10 shifts that are being utilized

• Required to work weekends and some holidays

Salary and Benefits:

• $36 to $42.75 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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. 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.

Job Locations US-CA-Thousand Oaks

Posted Date 4 days ago (12/16/2024 11:24 AM)

Requisition ID 2024-32677

Category Manufacturing

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies