Manager Investigations
Manager Investigations
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$ 131100 - 161900
1 Vacancy
Job Description
Position Summary:
ultraimpact Make a difference for those who need it most
As an investigator you will participate in investigation teams to identify root cause evaluate product and process impact develop effective CAPA and provide recommendations on batch disposition for deviations of high complexity. You will provide subject matter expertise on manufacturing processes to support deviations owned by other departments.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted onsite.
Responsibilities:
- Capability to resolve complex technical manufacturing investigations/projects related to cell and gene therapy manufacturing.
- Responsible for performing thorough detailed and timely investigations and generation of high quality and timely investigation reports.
- Experience with troubleshooting and providing solutions to complex technical and logistical issues
- Excellent written and verbal communication skills
- Ability to learn and apply Root Cause Analysis tools such as 5 Whys Fishbone IsIs Not and Scatterplot.
- Ability to develop collaborative relationships with all departments including operations MSAT quality control quality assurance Pharmaceutical Development and Facilities/Engineering teams.
- Apply business processes for investigation of manufacturing deviations leveraging process knowledge Quality and Operational Excellence toolkits.
- Provide regular updates to investigation stakeholders.
Requirements:
- Minimum B.S. degree in scientific field such as microbiology chemistry or biochemistry
- 4 years of experience in biopharmaceutical biotechnology cell or gene therapy industries with Manufacturing and Quality roles.
- Fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues.
- Ability to coordinate and facilitate meetings lead conversations and influence teams.
- Knowledge of domestic and international GMP regulations and their application in the manufacture of biologics cell or gene therapy products.
- Demonstrated ability to communicate technical information or complex situations to stakeholders in a concise and clear manner.
- Technical knowledge of the processes and systems involved in the manufacturing of biologics and ATMPs
- Experience with or ability to learn Six Sigma / DMAIC and investigation management techniques.
- Ability to facilitate and use of structured problem solving and Root Cause Analysis tools including 5 Whys Fishbone IsIs Not Scatterplot.
- Excellent technical writing skills. Prior experience authoring technical reports and regulatory submissions is desired
- Strong verbal communication skills. Demonstrated ability to communicate technical information or complex situations to senior leadership and/or health authority inspectors in a concise and clear manner #LICS1#LIOnsite
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
$131100 $161900 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:
Manager
Employment Type
Full Time
