Drug Development Project Manager
4 weeks ago
Position Title – Manufacturing Project Manager
Location – Thousand Oaks, CA
Shift – M-F 8-5
Pay Rate – $36 an Hour
Job Description:
Responsibilities include, but not be limited to; New Product Introductions (NPI) program management and non-capitol project management. The individual will be responsible for leading projects of diverse subjects and complexity and have proven strong communication and collaborative capabilities, both within and outside of the immediate team. The Sr Associate, Manufacturing will successfully inform, influence, and assign accountability to members of cross-functional teams that include; Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Job Responsibilities:
• Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right the First-Time approach.
• Strong project management skills, with prior project experience preferred.
• Timely closure of change control records in relation to procedural guidance and/or disposition timelines
• Represent Building 20 Manufacturing as the receiving site for incoming Technology Transfers/New Product Introductions into Building 20
• Identifying improvement opportunities within the organization and take pro-active steps to build consensus to implement those opportunities
• Succinctly communicate verbally and in writing to staff and leadership
• Presenting records and business processes to a variety of audiences, including auditors and inspectors
• Participating/leading Continuous Improvement Transformation activities
• Champion safety and compliance at all times
Experience Requirements
• Masters Degree
• Experience with PAS X Werum software for electronic batch records
• Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection
• Experience leading change controls in Trackwise
• Degree in life sciences or engineering
• Strong scientific, technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory
• Demonstrated technical writing skill
• Demonstrated ability to work in a team
Top 3 Must Have Skill Sets:
1. Project Management
2. Team Player
3. Attention Detail/ Quality Centric Mindset
organization, meeting minutes proactive willingness to keep self organized
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