Job Details
Our client, a renowned leader in the field of biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. As a guiding force in the biotech industry, they set the bar for innovation and advancement. We are excited to announce a fantastic opportunity to join the team as a Sr. Manufacturing Associate We are seeking a dynamic individual who is eager to contribute their expertise and drive their mission forward.
Title: Sr. Manufacturing Associate
Location: Thousand Oaks, CA
Pay: $35-37.50/hr
Shift: M-F 8am-5pm
Contract to hire
Job Duties:
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
Preferred Qualifications:
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