Manufacturing Specialist, Fill/Finish Operations
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a Manufacturing Specialist, Fill/Finish Operations who will be a contributing member of a team responsible for the successful technology transfer, operational readiness startup, and operation of our state-of-the-art allogeneic CAR T cell therapy manufacturing facility. The job scope includes the generation and implementation of manufacturing documentation, including batch records, logbooks, and standard operating procedures; support for implementation of manufacturing processes and systems; and assistance and troubleshooting through commissioning and qualification activities of the isolator and filling equipment.
This role will lead and participate in operational readiness activities with Manufacturing, Quality, Engineering, MS&T and/or IT to ensure the timely and smooth startup of the Newark facility. The candidate will provide expertise on fill/finish GMP activities of CAR T cell therapy products. This role will utilize knowledge of cGMP regulations and project management skills, as well as promote a culture f quality and compliance. The candidate will work with manufacturing management to ensure proper training is provided to all manufacturing floor staff. This position reports to the Director, Manufacturing and is based out of Newark, CA but may require periodic presence at headquarters in South San Francisco, CA.
The successful candidate will have experience in a regulated biotech or pharmaceutical setting and will have proven competency and expertise in isolator filling line technologies.
Responsibilities include, but are not limited to:
- Enable the successful technology transfer, startup, and operation of the GMP facility, partnering with Quality, Engineering and MS&T, with a strong focus on developing and implementing the isolator and filler technologies for CAR T drug product manufacturing.
- Support strategy for manufacturing documentation, including standard content and structure for batch records, standard operating procedures, forms, and logbooks.
- Lead and/or assist cross functional teams to develop manufacturing batch records, recipes, workflows, and standard operating procedures, ensuring that operational data, configurations, processes and reports meet all regulatory requirements.
- Ensure data integrity of various shop floor electronic systems.
- Author, review, own system related documentation.
- Support development of training materials and training of manufacturing staff
- Create and maintain a culture of continuous improvement and operational excellence
- Providing on and off-hour support to manufacturing.
- Lead and/or assist investigations as appropriate.
- Manage and approve deviations, non-conformances, change controls and CAPAs as required. Partner with Quality to address these issues effectively and compliantly.
- Collaborate with internal business partners on priorities, timelines and transparent sharing of information.
- Other duties as assigned
Position Requirements & Experience:
- 2 to 3 years of relevant experience with an MS degree or 3 to 4 years of relevant experience with a BS/BA or 5+ years relevant experience with an AS degree. Degree in biological sciences or engineering field strongly preferred.
- Expertise in isolator and filling line technologies; startup commissioning, qualification and validation experience strongly preferred.
- Experience in biologics manufacturing unit operations such as cell culture and aseptic processing preferred.
- Excellent communication, technical writing, and project management skills.
- Manufacturing document design proficiency demonstrated with formal training and experience.
- Demonstrated experience implementing software systems and performing tasks in a regulated or pharmaceutical production environment.
- Experience with complex process equipment and process automation systems.
- Understanding of ERP, LIMS, data historian, and other common manufacturing-related IT Systems.
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Willingness to think outside of the box and adapt best practices to our small, but growing environment.
- Ability to adapt in a constantly evolving environment.
- Self-motivated with a strong sense of ownership in areas of responsibility.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.
Physical Demands / Surroundings:
- Frequent use of a computer monitor, keyboard and mouse required
- Frequent lifting, carrying, pushing or pulling up to 30 pounds required
- Frequent periods of sitting, walking, and standing required
- Frequent use of personal protective equipment required
- Occasional climbing stairs or ladders, bending or stooping, crouching or squatting required
- Occasional fine finger dexterity/ including grasping or pinching required
- Occasional use of hazardous materials and chemicals required
- Occasional work in cold rooms and freezers required
Visual Demands:
- Color, vision, and depth perception required for inspection or test related jobs.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.