About Us:
aTyr is a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. aTyr’s discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by its proprietary library of domains derived from all 20 tRNA synthetases. aTyr’s lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease, a group of immune-mediated disorders that can cause inflammation and progressive fibrosis, or scarring, of the lungs.
Overview:
Patients and their challenges provide tremendous drive and meaning to what we do at aTyr. We seek a talented and successful individual that deeply desires to participate in our process to make medicines that change a patient’s life forever.
Role Description:
We are seeking a highly motivated and experienced individual to be an external manufacturing leader to ensure right first time delivery for efzofitimod late-phase drug substance. This role is critical for ensuring timely process validation execution and enabling a successful on time launch with high quality drug substance. Success elements for this position will be to establish clear and meaningful timeline expectations from internal and external teams while concurrently identifying associated risks for leadership to review. If you thrive in a Tech Ops environment and possess a unique blend of project management expertise, manufacturing technical understanding and logistical acumen, this position is for you.
Primary Responsibilities:
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- Oversee technical bioprocess design and execution of upstream and downstream processes at CDMOs by tracking vendor performance and process metrics
- Review current and past GMP and development data to synthesize actionable insights from process documentation and communicate this through technical reports or presentations to leadership
- Review process data to identify areas for yield improvement or process characterization studies to support at-scale ranges
- Collaborate with Tech Ops, Process Sciences, Quality, Regulatory and Clinical teams to assess and manage drug substance deviations, ensure adequate documentation to support disposition, and confirm that implemented CAPAs are effective
- Ensure compliance with all relevant cGMP regulations
- Coordinate and facilitate document review across internal CMC functions & external CDMO partners to ensure compliance, accuracy, and change control
- Identify scopes of work at CDMOs that are needed to support program needs and be responsible from initiation through tracking and closure activities.
- Contribute to CMC budgeting and timeline development
- Leverage your past manufacturing and development experience as the process owner for aTyr for during at-scale manufacturing via Person-In-Plant responsibilities (PIP)
- Occasional long travel periods will be required up to 50%
Qualifications:
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- Bachelor’s degree in science or engineering
- 4-6 years of relevant experience in a biotechnology or pharmaceutical company overseeing development or manufacturing at a CDMO
- Demonstrated E. coli upstream or downstream biologics manufacturing expertise
- Functional knowledge of GMPs with a proven track record of successful process design and execution
- Preference for candidates with late-phase or commercial supply experience
- Strong understanding of E. coli upstream or downstream development with scaling or transferring E. coli manufacturing processes
- Proficient in MS Excel, Smartsheet, Visio, ERP systems, and Power BI (or similar applications)
- Excellent analytical, problem-solving, and communication skills
- APICS , CSCMP, or PMP certification is a plus
Further Recruiting Information
The salary range for this position is $130,000-$157,000 per year. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. In addition to a competitive compensation package with stock options and an Employee Stock Purchase Plan, aTyr Pharma also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, life, disability, time-off, and 401(k)-matching contribution.
For additional information about aTyr Pharma, please visit our website at www.atyrpharma.com. aTyr Pharma, Inc. is committed to providing equal employment opportunities to all applicants and employees. We are committed to providing a workplace free of discrimination and harassment based on any protected characteristic. In accordance with the Americans with Disabilities Act (ADA) and other applicable laws, we will provide reasonable accommodations for qualified individuals with disabilities who are employees or applicants for employment, unless to do so would cause an undue hardship.
For consideration, please submit your resume and cover letter referencing job #222CS to jobs@atyrpharma.com. aTyr Pharma, Inc. is an EEO employer.