Project Manager, Biosimilars Business Unit PD/Operation Group

Company: Randstad USA
Location: Thousand Oaks
Posted on: November 6, 2024

Job Description:

Job Summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you! Location: Newbury Park, California Job Type: Contract Salary: $65.00 - 74.52 per hour Work Hours: 9 to 5 Education: High School Responsibilities:

• Provide project management to technical teams responsible for developing biosimilar candidates through to regulatory approval.
• Provide project management of biosimilar business unit (BBU) analytical similarity sample management.
• Collaborate closely with cross-functional teams including Similarity Team, Critical Regents Group (CRG), Data Management, and scientific staff to plan and maintain inventory.
• Manage logistics for distribution of samples for testing and communicate incoming data for biosimilar projects.
• Create electronic laboratory notebooks (ELN) for sample submission.
• Generate lot number, sample ID, and retrieve data in QC LIMS.
• Assist BBU staff with navigating ELN software and placing work orders for ELN updates. Perform database queries of LIMS, ELN, and other databases including compiling and organizing data for review, verifying independently or in coordination with Data Management.
• Retrieve and organize data for review with Data Management.
• Document archival in controlled document repository.
• Provide data verification as needed for internal documents and regulatory filings in controlled document system.
• Utilize a strong foundation in scientific principles to thoroughly review regulatory documents and accurately determine the data elements that require verification in accordance with established protocols.
• Collaborate with cross-functional teams to ensure the completion and accuracy of the data verification processes.
• Assist in formatting documents in compliance with the company's internal style guidelines and standards. Qualifications:
  • Doctorate degree OR Master degree and 2 years of experience OR Bachelor degree and 4 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience. Skills: Project Management, MS-WORD, MS-EXCEL, MS-Powerpoint, MS-Project, PMP Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). This posting is open for thirty (30) days. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers. We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
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Keywords: Randstad USA, Mission Viejo , Project Manager, Biosimilars Business Unit PD/Operation Group, Executive , Thousand Oaks, California