Senior Quality Control Analyst I, Bioassay

Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team .

Position Summary:

ultra innovative – Tackle rare and dynamic challenges

The Senior QC Analyst position will execute an interdisciplinary set of testing (e.g. microbiology testing, molecular biology testing and bioassay testing) and laboratory operations (e.g. sample management) to support AAV-based gene therapy manufacturing operations on a shift. The incumbent will demonstrate strengths in leadership in the lab with a focus on sound independent thinking and a self-motivated mindset to drive actions forward.

In addition, the Senior QC Analyst I will review, enter and approve analytical data generated internally and from external laboratories. Routine work includes release and stability testing, critical reagent qualification, quality system ownership (e.g. OOS investigations, deviations, CAPA, change controls), method validation and transfer, critical reagent qualification, analyze data, and author technical documents.

The position is scheduled Wednesday – Saturday as four 10 hour work days with flexibility to start between 7:00am – 8:30am to support operational activities.

Work Model:

Core Lab Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

Performs routine QC testing in a GMP environment to support product release and stability including but not limited to; cell-based assays, quantitative PCR, ELISA, and microbiological test methods (e.g. bioburden testing, plate reading, endotoxin testing, total organic carbon testing, conductivity testing, media growth promotion).

Executes sample management in support of GMP manufacturing including, but not limited to, incoming sample receipt, sample aliquoting, sample transactions in LIMS, sample distribution to testing laboratories and sample disposal.

Review and approval of cGMP analytical data for release and stability testing

Supports and leads QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc).

Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.

Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.

Author analytical method performance trend reports, as needed.

Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).

Model leadership behaviors and mentor/train junior staff

Work  with cross functional teams with both internal and external stakeholders

Requirements:

BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 6-8+ years industry experience or MS with 4-6 years’ experience.

4+ Experience in a GMP/GLP environment is a must.

Experience in routine mammalian cell culture required

Experience with quantitative PCR required. Experience with cell-based potency assays is required. Experience performing immunoassays such as ELISAs strongly desired

Experience with statistical analysis (SoftMax, JMP) and LIMS (LabVantage) preferred

Ability and desire to work in a fast-paced environment

Strong collaboration, team-working skills, and communication skills

Independently motivated and detail-oriented with good problem-solving ability

Strong communication, interpersonal and organizational skills

Physical Demand Requirements

Stand for extended periods of time with periodic stooping / bending / kneeling

Able to lift, push, pull up to 50lbs.

Climb ladders and stairs of various heights.

Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and bo…