Manufacturing Associate II - 7am to 7pm - Pitman schedule

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:

ultrafocused – Work together to fearlessly uncover new possibilities

Our Manufacturing Associates support Ultragenyx’s Gene Therapy Manufacturing Facility in Bedford, MA. In this role you will report to the Associate Director of Drug Product. The Associates will be involved in daily process review meetings, routine formulation/filling operations and visual inspection of finished Drug Product vials. Must be detail-oriented with troubleshooting abilities. You will be expected to be knowledgeable in cleaning and operation of equipment (parts washers, autoclaves/sterilizers, fillers, and isolators in a clean room environment), sterile gowning, and primary labeling/packaging operations.

Work Model:

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

This is a shift based position from 7am to 7pm on a Pitman rotation.

Responsibilities:

• Support the execution of all activities in compliance with environmental health and safety (EHS) requirements, and good manufacturing procedures (cGMPs)

• Follows written procedures and document results in a neat and accurate manner according to GMP standards and other regulations

• Supports quality investigations, continuous improvement efforts, and engineering activities as they directly impact the functionality of the manufacturing areas.

• Operate and maintain drug product manufacturing equipment and support the maintenance process.

• Execute Drug Product setup and breakdown of all equipment

• Execute visual inspection of sterile filled containers (vials) in accordance with all applicable procedures, regulations and safety directives

• Ensure maintenance and upkeep of the facility and processes within area of responsibility

• Maintain training and qualification to enable aseptic processing operations

• Ensure the controlled spaces maintain the required inventory and are equipped with the necessary materials, tools, and equipment.

• Maintain manufacturing records that comply with CGMPs and internal quality system requirements

Requirements:

• High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience

• 2+ years’ experience preferably in pharmaceutical manufacturing or other regulated industry

• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.

• Experience with viral vectors is not required but preferred

• Ability and desire to work in a fast-paced is essential

• Strong collaboration, team-working skills and communication skills

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

• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook)

• Willingness to perform “hands on” work in a cleanroom environment. Gowning and aseptic processing experience essential.

• Thorough knowledge of GMP’s and a clear understanding of EH&S regulations that pertain to the operations function

.Physical Demand Requirements:

Manufacturing: Drug Product Manufacturing Assoc:

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

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

• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.

• Must complete and pass a vision exam to verify clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors with or without correction.

#LI-CT1 #LI-Onsite

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range
$78,300—$96,700 USD

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 [email protected].

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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: [email protected].