Manufacturing Associate III (Drug Substance) - shift work 2:00PM - 10:30PM
Manufacturing Associate III (Drug Substance) - shift work 2:00PM - 10:30PM
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Job Description
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
The Manufacturing Associate will be a key member of the Drug Substance Manufacturing team responsible for the onthefloor operations at our Gene Therapy Manufacturing Facility. The Manufacturing Associate will be ensuring GMP compliance as well as writing SOPs and batch records to support plant operations. Must be detailoriented with troubleshooting abilities. You will be expected to be knowledgeable in purification operations (chromatography TFF Viral Filtration Membrane Filtration) and singleuse disposable technology.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted onsite on a shift basis 2:00PM 10:30PM.
Responsibilities:
- Ensure high standards of cGMP are always adhered to.
- Must be able to efficiently operate the Veeva Vault system for all quality documentation Deviations Change Controls and CAPA systems.
- Develop write and revise GMP documents and templates including batch records SOPs OJTs and logbooks.
- Drive to closure the manufacturing review of the completed batch records in a timely manner per established targets.
- Ensure high standards of cGMP documentation completion are always adhered to.
- Demonstrate a thorough and complete understanding of safety requirements and GMP compliance of the plant and process.
- An Operational Excellence champion driving medium level continuous improvements to the process or systems.
- Represents manufacturing in Project team meetings as required.
Requirements:
- Typically requires a university degree and a minimum 4 years of related experience
- 2 yr degree with 6 yrs or
- No degree with 8 years
- GMP manufacturing experience preferably in pharmaceutical manufacturing.
- Strong collaboration teamwork and communication skills
- Independently motivated and detailoriented with good problemsolving 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:
- Stand for extended periods of time with periodic stopping / 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 makeup jewelry and contact lenses while in the manufacturing environment.
- Working in temperaturecontrolled environments (cold rooms).
The typical annual salary range for this fulltime 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
Part-Time
