Manufacturing Associate II, Drug Substance Upstream - Gene Therapy - Day Shift (Pitman rotation)

Manufacturing Associate II, Drug Substance Upstream - Gene Therapy - Day Shift (Pitman Rotation)

Bedford, MA

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 focused Work together to fearlessly uncover new possibilities

The Manufacturing Associate II will be a suite-based position within the Gene Therapy Manufacturing facility. The position is a suite/clean room-based position where the Associate II position will be an on the floor technician assigned to the Upstream Manufacturing area. Expertise will include all cell thaw and culture activities through the various scale of bioreactors up to 2000L and harvest operations. The position is scheduled from 12:00 PM to 12:00 AM on a Pitman rotation, with the potential to transition to a 7:00 PM to 7:00 AM shift based on facility demand.

Work Model:

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

Responsibilities:

1. Ongoing maintenance of own training file ensuring full training has taken place for all aspects of the production activities in the GTMF area.
2. Overseeing and driving their training in the GTMF area to enable them to carry out their duties efficiently and compliantly.
3. Be able to operate efficiently the Veeva Vault system for all quality documentation.
4. Ensure that high standards of cGMP are adhered to at all times.
5. Revise GMP documents and templates including batch records, SOPs, OJTs and logbooks.
6. Ensure that high standards of cGMP documentation completion are adhered to at all times and documentation is left in a reviewable condition at all times.
7. Demonstrate ownership of the process to ensure that all resources (materials, personnel, documentation etc.) required for processing are available.
8. Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process.
9. Strive to become a subject matter expert for all "assigned" equipment in the area of control.
10. Identification of immediate actions/escalation needed to mitigate risk to product, employee safety or schedule as appropriate.
11. Identify any Continuous Improvements to the process/equipment and drive through to completion any projects to which may be assigned.
12. Ensure high standards of housekeeping are adhered to at all times.
13. Participate in internal/regulatory audits as required.
14. Attend project and other meetings as required.
15. Ensure effective liaison and communication with other departments, maintaining good relations at all times.
16. Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite.
17. Ensure that objectives given are met in the appropriate agreed to timescale.

Requirements:

1. High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience.
2. 4+ years' experience preferably in pharmaceutical manufacturing or other regulated industry co-op, and internship experience is considered.
3. Experience with viral vectors and/or biological processes.
4. Strong collaboration, team-working skills and communication skills.
5. Ability and desire to work in a fast-paced, start-up environment is essential.
6. Independently motivated and detail-oriented with good problem-solving ability.
7. Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

Physical Demand Requirements

General Manufacturing: Drug Substance/Central Svcs:

• 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 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.
• Certain tasks may require the use of a respirator; medical clearance will be required in advance.
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.
• Working in temperature-controlled environments (cold rooms).

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 View email address on click.appcast.io .