This job is archived
(Archived) Technical Project Manager
Job Description
Position Summary
The position is for a working technical project manager. The successful candidate will will effectively manage and coordinate Reference Qualification technical and non-technical projects and initiatives at the Lincoln site. The scope of the support will include projects associated with in-line biologic product references and/or reference standards, reference monitoring, VMRD transfers of assays for reference monitoring, and cost-improvement projects. The position will be responsible for the change control process associated with projects and therefore requires strong leadership and demonstrated communication skills in order to collaborate across organizational lines (QO, QC, RA, VMRD, EHS and MFG ops) to ensure timely implementation of projects and initiatives. The ideal candidate would have a strong biological background in analytical methods. The candidate will be required to understand key technical data in order to be a representative for the site on VMRD-led Co-development teams that involve references.
Position Responsibilities
The successful candidate will be expected to deliver allocated projects on time and budget in order to meet business objectives. The candidate will be expected to make decisions that impact their own work and exercise judgment to complete assigned tasks. The candidate will lead cross-functional teams to support reference-related initiatives as their primary role. The candidate will be expected to manage the following team dynamics:
1. Accountability,
2. Consensus building,
3. Definition of team roles and responsibilities,
4. Facilitate recommendations of team to management and
5. Deliver projects on time and budget.
Education and Experience
B.S. degree in biological or related science with emphasis in microbiology, virology, bacteriology, or immunology
• Minimum of 5 years’ experience in Biologics industry with at least 2 - 3 years of experience in Reference Qualification.
Preferred:
• Minimum of 10 years’ experience in Biologics industry with at least 1 - 5 years of experience in Reference Qualification.
• Five or more years of experience in assay validations.
• Five or more years of experience in general and technical management of projects with demonstrated ability to resolve technical issues, addresses validation requirements, prepares and administers budgets.
• Demonstrated expertise in areas of Biological sciences including production, Quality control, Compliance, Regulatory Affairs and Biological Research and development will be considered strongly.
• Additional key attributes desired are demonstrated ability to function and influence in a team/matrix environment, good interpersonal skills, communication skills, computer skills and working knowledge of key regulatory authorities (USDA, FDA).
• Demonstrated expertise in Project management/Coordination. Prior people leadership experience is a plus.
Technical Skills and Competencies
• Laboratory and/or manufacturing experience in biological manufacturing and/or testing is desirable. A working knowledge of vaccine production methods and experimental design and experience in GLP or GMP is also desirable.
• Regulatory experience in reference qualification / requalification.
• High degree of personal motivation and attention to detail. Strong oral and written communication, excellent interpersonal skills, strong commitment to product quality, continuous improvement and working knowledge of RFT (Right First Time) principles.
Physical Position Requirements
Typical office based working conditions of sitting at the computer and teleconferencing. Some travel may be required as part of project transfers. Occasional weekend work may be required.
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