Manufacturing Specialist

1 Year (Extendable)

Thousand Oaks, CA

Max PR: $43-47/hr

100% ONSITE ROLE SUPPORTING FACILITY.

HIRING NOTES:

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

Why is the Position Open?

• Planned Project

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

Possible Extension:

• Yes

Red Flags:

• No prior project experience, no prior work experience

Interview Process:

• 2, video conference

Summary

• Part of the Drug Product New Product Introduction Team at Company Thousand Oaks. This building 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:

• Master’s Degree
• Bachelor’s 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