Technical Project Support Specialist
Technical Project Support Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Setup and facilitate key analyticalfocused team meetings
- Coordinate authoring review and approval of critical analytical documents
- Perform secondperson review on analytical reports and memos
- General operational support for analytical working groups for commercial biologic/vaccine programs
- Collaborate across internal network external partners international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of large molecule analytics
- Coordinate with analytical and process development groups to prepare for analytical troubleshooting validation and technology transfers
- Support coordination of analytical activities across teams of subject matter experts to maintain or troubleshoot biochemical immunochemical and chromatographybased analytical methods
- Support coordination of analytical method transfers and/or assay method validations including authoring and coordinating review of protocols and reports
- Project manage change controls related to analytical method or specification change controls
Qualifications :
Basic Minimum Qualifications:
- Bachelors of Science (Biology Chemistry Biochemistry or related sciences) AND two (2) years of working in a related role OR
- Masters of Science preferably with experience in a related role
- Minimum of two (2) years of large molecule (vaccine or biologics) method development validation or project management
- Minimum of two (2) years of working knowledge of a GMP laboratory environment
- Technical writing experience
- Ability to work in a fastpaced teamoriented setting
- Excellent communication (oral and written) and attention to detail
- Authorization to work in the United States indefinitely without restriction or sponsorship
The Ideal Candidate would possess:
- Proven ability to manage multiple projects/tasks simultaneously
- Demonstrated selfstarter with capability to develop innovative solutions to challenges
- Excellent communication skills oral and written
- Strong organization and attention to detail
- Ability to learn new techniques quickly keep accurate records follow instructions and comply with company policies as well as regulatory/GMP requirements
- Ability to work independently and as part of a team selfmotivation adaptability and a positive attitude
- GMP large molecule method development validation and/or project management experience
- Understanding of regulatory filings (IND MAA BLA)
Change control experience
Additional Information :
Position is fulltime MondayFriday generally 8 a.m. 5 p.m. with overtime as needed. Candidates currently living within a commutable distance of West Point PA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
