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Ultragenyx
3.4
Senior Quality Control Analyst I, Bioassay
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$102K - $125K (Employer provided)
Executes sample management in support of GMP manufacturing including, but not limited to, incoming sample receipt, sample aliquoting, sample transactions in……
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Ultragenyx

3.4

Senior Quality Control Analyst I, Bioassay

Woburn, MA

$102K - $125K (Employer provided)

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this job description.

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:

ultrainnovative – 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 body. This role requires the ability to wear personal protective equipment.
Certain tasks may require use of a respirator; medical clearance will be required in advance.

#LI-AJ1 #LI-Onsite

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

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

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 or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

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. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request 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.

See company reviews

Base pay range

The minimum salary is $102K and the max salary is $125K.

$102K – $125K/yr (Employer provided)

$113K

/yr Median

Woburn, MA

If an employer includes a salary or salary range on their job, we display it as "Employer Provided". If a job has no salary data, Glassdoor displays a "Glassdoor Estimate" if available. To learn more about "Glassdoor Estimates," see our FAQ page.

Working here doesn’t have to be a secret

3.4

Recommend to a friend
Approve of CEO
CEO: Emil Kakkis
154 Ratings

Ultragenyx

3.4

Senior Quality Control Analyst I, Bioassay

Woburn, MA

$102K - $125K (Employer provided)

Ultragenyx

3.4

Senior Quality Control Analyst I, Bioassay

Woburn, MA

$102K - $125K (Employer provided)

Is your resume a good match?

Use AI to find out how well the skills on your resume fit this job description.

Why Join Us?

Be a hero for our rare disease patients

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:

ultrainnovative – Tackle rare and dynamic challenges

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 body. This role requires the ability to wear personal protective equipment.
Certain tasks may require use of a respirator; medical clearance will be required in advance.

#LI-AJ1 #LI-Onsite

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

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

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

See company reviews

Base pay range

The minimum salary is $102K and the max salary is $125K.

$102K – $125K/yr (Employer provided)

$113K

/yr Median

Woburn, MA

Working here doesn’t have to be a secret

3.4

Recommend to a friend
Approve of CEO
CEO: Emil Kakkis
154 Ratings

Are you open to new opportunities?

37,319 It process analyst jobs in United States

Position Summary:

Work Model:

Responsibilities:

Requirements:

Base pay range

Working here doesn’t have to be a secret

Position Summary:

Work Model:

Responsibilities:

Requirements:

Base pay range

Working here doesn’t have to be a secret