Description:
Note:
100% ONSITE ROLE SUPPORTING ATO FACILITY.

Manufacturing Specialist Job Description:

• Part of the Drug Product New Product Introduction Team at Thousand Oaks, Building 20. Building 20 is a clinical and commercial syringe and vial filling facility supporting patients worldwide.
• Responsibilities include, but are not 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 Manufacturing Specialist 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:

• Succinctly communicate verbally while leading meetings and in writing to staff and leadership
• Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right-First-Time approach.
• Strong project management skills, with prior project experience a must
• Lead meetings with cross functional teams to align on change scopes and impact assessments when new products are introduced to the Building 20 Manufacturing Facility
• 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
• 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
• Bachelors Degree in life sciences or engineering
• Experience using Trackwise software
• Prior experience leading cross-functional teams to align on CAPAs and closing deviations
• Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP Formulation, DP Filling, Inspection
• Strong scientific, technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory
• Demonstrated technical writing skills
• Demonstrated ability to work in a team

Basic Qualifications

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Top 3 Must Have Skill Sets:

• Clear communicator, Cross functional team leader, project management, problem resolution

Day to Day Responsibilities:    

• Set up meetings with stakeholders to gather impact assessments as a result of new product introductions
• Own change controls in Trackwise software
• Resolve project timeline issues and influence discussions toward problem resolution
• Track and clearly communicate NPI statuses
• Manage cross functional teams that do not report directly to you

Pay Rate  between $42 - $47/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"