POSITION OBJECTIVE: In this position based in the Buffalo NY, you will be responsible for the development, refinement, implementation and oversight of cGMP-compliant processes related to the manufacture and testing of cell therapies for clinical evaluation in accordance with current regulatory guidelines and recommendations. 


The successful candidate will also contribute to the drafting, review, and revision of technical documents related to cell manufacturing including but not limited to Standard Operating Procedures (SOPs) and batch records. You will work closely with other Athenex teams and disciplines to align the cell therapy program with Quality standards expected for the modern cGMP-compliant manufacture of cell therapy products for early and mid-stage clinical evaluation.   


Essential Job Functions/Responsibilities

·      Coordinate and oversee all aspects of cGMP-compliant manufacture of cell therapies contracted to a 3rd party (eg; CDMO) and/or internally within the dedicated Athenex cGMP Facility. 

·      Collaborate with cross-functional teams (e.g. Quality) to identify and prioritize development activity requirements for manufacturing.

·      Provide technical input and support for production related investigations, ensuring compliance with study design, internal standards and regulatory requirements.

·      Review and revision of documentation related to manufacturing and facility operations per compliance standards and established company timelines.

·      Assist with efforts related to recruitment and building a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews.

·      Supervise and train facility staff to comply with GMP standards and ensure company and facility SOPs are followed.

·      Ensure facility staff have and maintain the appropriate level of training necessary for cell therapy GMP manufacturing in a multi-product development facility.

·      In accordance with Athenex SOPs, work with vendors, contractors and professional service providers to ensure the quality of contracted work and services necessary to proper and optimum facility operations.

·      Support and help coordinate facility audits and inspections from regulatory agencies relative to cGMP processes, utilities, worker safety, waste removal, validation and commissioning of operations.

·      Stay current with all pertinent federal, state and company regulations, laws and policies as they presently exist and as they evolve. Promote a general mindset of continuous improvement, problem solving, quality by design, and prevention.

·      Able to work off-shift hours and weekends, as well as provide on-call support as required.

·      May perform other duties as assigned

 

Required Education & Experience

·      Advanced degree (Masters or higher) in biology or related field (or equivalent experience required).

·      3-5 years of experience working cGMP-compliant operations of a cleanroom facility and/or other specialized facilities and equipment required for GMP compliant manufacturing of regulated cell therapy products.

·      Minimum of 2 years of project management or supervisory experience required

·      Demonstrated experience in a regulated biotech, academic or pharmaceutical setting with proven competency and expertise in the cGMP compliant manufacture of cell-based therapies.


Required Skills & Abilities:

·      Proficient in MS Office applications.

·      Knowledge and understanding of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's).

·      Advanced understanding of cell culture, cryopreservation, purification, and aseptic processing or lab techniques.

·      Basic knowledge of facility/clean room design, process, equipment, automation, and validation

·      Excellent interpersonal, verbal and written communication skills that enhance an existing collaborative teamwork-oriented environment.

·      Ability to prioritize and provide clear direction to team members in a highly dynamic environment.

·      Basic knowledge of quality by design and risk management.

·      Ability to build and manage a team as well as supervise and train entry-level team members.

·      Innovative, strategic mindset with informed, sharp, and objective practical purpose, experienced in detailed analysis, interpretation, and reporting.

·      Self-motivated with a strong sense of ownership in areas of responsibility. Conduct hands-on experimentation as needed.

 

 

Working Conditions:

·      Comfortable with gowning procedures and requirements for working under GMP conditions specific to cell therapies for extended periods (up to 8 hours in most cases).



Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. 


Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.


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