Senior Specialist, Quality Assurance Operations Drug Substance (7am - 5:30pm - S
Ultragenyx Pharmaceutical, Bedford, MA, United States
Position Summary
As Quality Assurance Drug Substance (DS) Specialist, you will be responsible for QA activities at the new gene therapy manufacturing facility located in Bedford, MA. You will provide direct QA oversight and support for core Drug Substance Manufacturing activities, including Production Batch Record review, deviation management, QA Manufacturing walkthroughs, logbook review and room/equipment tag‑out for manufacturing use. The site is a multi‑product facility used for drug substance manufacturing and aseptic filling of drug product. QA activities focus primarily on the drug substance manufacturing areas but may also support Drug Product when required. Your role will partner with Manufacturing, Engineering, Validation, QC, Quality Systems and MSAT functions to provide QA approval for operating procedures, DS manufacturing processes and batch records required for ongoing manufacturing at the facility. You will report to the Associate Director, Quality Assurance at Ultragenyx Gene Therapy.
Work Model
Core Lab & Ops: This role typically requires that the majority of the work be conducted on‑site.
Responsibilities
Review and approve Master Batch Records and executed DS Production Batch Records
Perform QA review/approval of DS area shutdowns and restarts after planned or unplanned maintenance or EM events
Perform routine area walkthroughs, logbook reviews and inspection readiness assessments
Write, review and/or approve documents such as SOPs, work instructions, policies and standards to enable GMP manufacturing
Work with functions to resolve deviations and assess potential product and compliance impact; Escalate significant events to Quality Management and drive timely completion of effective investigations
Drive or support continuous improvement activities to eliminate waste and enable an effective and efficient manufacturing site/process; Champion process improvement where applicable
Requirements
Minimum B.S. degree in a scientific field such as microbiology, chemistry or biochemistry. 5+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with manufacturing and quality roles.
Direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site; knowledge of drug substance and aseptic practices.
Knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell or gene therapy products.
Demonstrated ability to communicate technical information or complex situations to site management and/or health authority inspectors in a concise and clear manner.
Physical Demands / Work Environment / Safety Considerations
Stand for extended periods of time with periodic stooping, bending or kneeling
Able to lift, push or pull up to 50 lbs
Climb ladders and stairs of various heights
Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet and body; ability to change into appropriate gowning and personal protective equipment
Certain tasks may require the use of a respirator; medical clearance will be required in advance
Must remove all makeup, jewelry and contact lenses while in the manufacturing environment
Work in temperature‑controlled environments (cold rooms)
Pay Range
$105,300 - $130,100 USD
Benefits
Generous vacation time and public holidays observed by the company
Volunteer days
Long term incentive and employee stock purchase plans or equivalent offerings
Employee wellbeing benefits
Fitness reimbursement
Tuition sponsoring
Professional development plans
* Benefits vary by region and country
Additional Information
#LI-CS1 #LI-Onsite
Ultragenyx Pharmaceutical is an equal‑opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status and any other status or classification protected by applicable federal, state and/or local laws. Reasonable accommodation will be provided for all protected statuses. Applicants may request accommodation prior to accepting a job offer; if you require accommodation in completing this application or in any part of the recruitment process, you may contact Talent Acquisition at talentacquisition@ultragenyx.com.
See our CCPA Employee and Applicant Privacy Notice.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Note to External Recruiters
All candidate activity and open positions are managed strictly through our Human Resources Department. Recruiters are kindly requested not to contact employees or hiring managers directly in an attempt to solicit business and present candidates. Failure to comply will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to talentacquisition@ultragenyx.com.
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As Quality Assurance Drug Substance (DS) Specialist, you will be responsible for QA activities at the new gene therapy manufacturing facility located in Bedford, MA. You will provide direct QA oversight and support for core Drug Substance Manufacturing activities, including Production Batch Record review, deviation management, QA Manufacturing walkthroughs, logbook review and room/equipment tag‑out for manufacturing use. The site is a multi‑product facility used for drug substance manufacturing and aseptic filling of drug product. QA activities focus primarily on the drug substance manufacturing areas but may also support Drug Product when required. Your role will partner with Manufacturing, Engineering, Validation, QC, Quality Systems and MSAT functions to provide QA approval for operating procedures, DS manufacturing processes and batch records required for ongoing manufacturing at the facility. You will report to the Associate Director, Quality Assurance at Ultragenyx Gene Therapy.
Work Model
Core Lab & Ops: This role typically requires that the majority of the work be conducted on‑site.
Responsibilities
Review and approve Master Batch Records and executed DS Production Batch Records
Perform QA review/approval of DS area shutdowns and restarts after planned or unplanned maintenance or EM events
Perform routine area walkthroughs, logbook reviews and inspection readiness assessments
Write, review and/or approve documents such as SOPs, work instructions, policies and standards to enable GMP manufacturing
Work with functions to resolve deviations and assess potential product and compliance impact; Escalate significant events to Quality Management and drive timely completion of effective investigations
Drive or support continuous improvement activities to eliminate waste and enable an effective and efficient manufacturing site/process; Champion process improvement where applicable
Requirements
Minimum B.S. degree in a scientific field such as microbiology, chemistry or biochemistry. 5+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with manufacturing and quality roles.
Direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site; knowledge of drug substance and aseptic practices.
Knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell or gene therapy products.
Demonstrated ability to communicate technical information or complex situations to site management and/or health authority inspectors in a concise and clear manner.
Physical Demands / Work Environment / Safety Considerations
Stand for extended periods of time with periodic stooping, bending or kneeling
Able to lift, push or pull up to 50 lbs
Climb ladders and stairs of various heights
Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet and body; ability to change into appropriate gowning and personal protective equipment
Certain tasks may require the use of a respirator; medical clearance will be required in advance
Must remove all makeup, jewelry and contact lenses while in the manufacturing environment
Work in temperature‑controlled environments (cold rooms)
Pay Range
$105,300 - $130,100 USD
Benefits
Generous vacation time and public holidays observed by the company
Volunteer days
Long term incentive and employee stock purchase plans or equivalent offerings
Employee wellbeing benefits
Fitness reimbursement
Tuition sponsoring
Professional development plans
* Benefits vary by region and country
Additional Information
#LI-CS1 #LI-Onsite
Ultragenyx Pharmaceutical is an equal‑opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status and any other status or classification protected by applicable federal, state and/or local laws. Reasonable accommodation will be provided for all protected statuses. Applicants may request accommodation prior to accepting a job offer; if you require accommodation in completing this application or in any part of the recruitment process, you may contact Talent Acquisition at talentacquisition@ultragenyx.com.
See our CCPA Employee and Applicant Privacy Notice.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Note to External Recruiters
All candidate activity and open positions are managed strictly through our Human Resources Department. Recruiters are kindly requested not to contact employees or hiring managers directly in an attempt to solicit business and present candidates. Failure to comply will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to talentacquisition@ultragenyx.com.
#J-18808-Ljbffr