Manufacturing Associate II, Drug Substance Upstream - Gene Therapy - Day Shift (Pitman rotation)
Posted 15 days ago
Position Summary:
ultrafocused – 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:
- Ongoing maintenance of own training file ensuring full training has taken place for all aspects of the production activities in the GTMF area.
- Overseeing and driving their training in the GTMF area to enable them to carry out their duties efficiently and compliantly.
- Be able to operate efficiently the Veeva Vault system for all quality documentation.
- Ensure that high standards of cGMP are adhered to at all times.
- Revise GMP documents and templates including batch records, SOPs, OJTs and logbooks.
- 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.
- Demonstrate ownership of the process to ensure that all resources (materials, personnel, documentation etc.) required for processing are available.
- Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process.
- Strive to become a subject matter expert for all “assigned” equipment in the area of control.
- Identification of immediate actions/escalation needed to mitigate risk to product, employee safety or schedule as appropriate.
- Identify any Continuous Improvements to the process/equipment and drive through to completion any projects to which may be assigned.
- Ensure high standards of housekeeping are adhered to at all times.
- Participate in internal/regulatory audits as required.
- Attend project and other meetings as required.
- Ensure effective liaison and communication with other departments, maintaining good relations at all times.
- Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite.
- Ensure that objectives given are met in the appropriate agreed to timescale.
Requirements:
- High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience.
- 4+ years’ experience preferably in pharmaceutical manufacturing or other regulated industry co-op, and internship experience is considered.
- Experience with viral vectors and/or biological processes.
- Strong collaboration, team-working skills and communication skills.
- Ability and desire to work in a fast-paced, start-up environment is essential.
- 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).
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).
#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.
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].
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.
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Leading with purpose. Every day. “Ultragenyx was founded to advance innovative medicines for rare and ultrarare diseases that have never been treated before. We are delivering transformative therapies across multiple indications, and we have one of the most robust and diverse clinical pipelines in rare disease. Our focus is on doing the right things for patients both during development and commercialization to deliver on the promise of these therapies in a way that's meaningful for rare disease communities.” Emil D. Kakkis, M.D., Ph.D. Chief Executive Officer and President We have an inclusive culture of value and respect. Ultragenyx brings novel products to those living with rare and ultrarare diseases with a focus on debilitating genetic diseases. Founded in 2010, we have rapidly built a diverse portfolio of approved therapies and products aimed at diseases with a high unmet medical need for which many have no approved therapies. It takes courage, care, talent, and dedication to make a meaningful impact for those living with rare diseases, their families and the rare disease community. We put our people first, so they can take care of the rare disease community. We purposefully cultivate and nurture a dynamic, supportive work environment where we encourage every team member to share their new ideas and help us unlock more possibilities. Our team is made up of exceptional and diverse people with a strong passion and commitment to helping those living with rare diseases. By embracing generosity, curiosity, inclusion, and humility we are constantly learning together—fostering an environment that supports profound growth and fulfillment. If you want to have a meaningful impact, do the best work of your career while having fun and growing professionally and personally, come join our team! Visit our community guidelines at: https://ultragenyx.co/community
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