Manufacturing Associate III, Drug Substance Upstream (7am to 7pm Pitman rotation)
Manufacturing Associate III, Drug Substance Upstream (7am to 7pm Pitman rotation)
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Job Description
Position Summary:
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The Manufacturing Associate III will be a suite based position within the Gene Therapy Manufacturing facility. The position is a suite/clean room based position where the Associate III 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.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. The shift is from 7am to 7pm on a Pitman Rotation.
Responsibilities:
Quality Systems
- 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.
- Carry out the manufacturing review of the completed batch records in a timely manner per established targets.
- Assist in Lot Disposition activities including deviation follow ups in a timely manner.
- Ownership (Closure Driver) of all assigned deviations and CAPAs
Documentation
- Create write and revise GMP documents and templates including batch records SOPs OJTs and logbooks.
- Completion of change control forms and Deviations plus subsequent implementation of changes and follow up actions.
- 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.
Plant and Process
- Demonstrate in depth knowledge 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.
- Ongoing maintenance of own training file ensuring full training has taken place for all aspects of the production activities in the GTMF area
- Strive to Become a subject matter expert for all assigned equipment in the area of control.
- Identify and drive any Continuous Improvements to the process/equipment.
Batch Ownership
- Identification of immediate actions/escalation needed to mitigate risk to product employee safety or schedule as appropriate.
- Initiation of MFG related Quality Incidents as required.
- Identify any Continuous Improvements to the process/equipment and drive through to completion any projects to which may be assigned.
Miscellaneous
- 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.
- 2-4 years experience in a Biologics Manufacturing setting
- Experience with viral vectors would be beneficial for this role #LI-Onsite #LI-CT1
Physical Demands:
- 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 applicants 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
$86000 - $106300 USD
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 .
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.
Required Experience:
IC
Employment Type
Full Time
