MCS Manufacturing Sr. Associate

Summary:
As a Senior Associate Manufacturing, you will be part of the New Product Introduction Team at Thousand Oaks, supporting clinical and commercial manufacturing operations. This role encompasses program and project management, change control ownership, and continuous improvement initiatives. You will work cross-functionally to ensure timely delivery of new products and operational excellence, with a focus on quality, safety, and compliance.

Responsibilities:

• Change Control and Project Management:
• Own and manage change controls for new product introductions (NPI).
• Ensure records are comprehensive and compliant per GMP regulatory procedures with a Right the First-Time approach.
• Lead projects of diverse subjects and complexity, ensuring timely closure of change control records.
• Represent Manufacturing as the receiving site for incoming Technology Transfers/New Product Introductions.
• Use project management tools and methodologies to plan, monitor, and report on project progress and outcomes.
• Continuous Improvement and CAPA Management:
• Lead and execute Corrective and Preventative Actions (CAPAs) and Effectiveness Verifications (EVs) related to Epogen production.
• Identify and implement continuous improvement opportunities to enhance process efficiency, quality, and safety.
• Participate in Continuous Improvement Transformation activities.
• Initiate and drive continuous improvement projects within the organization.
• Collaboration and Communication:
• Work in a highly collaborative team environment, interacting with Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
• Communicate effectively with internal and external partners, including quality, engineering, validation, regulatory, and suppliers.
• Present records and business processes to a variety of audiences, including auditors and inspectors.
• Succinctly communicate verbally and in writing to staff and leadership.
• Operational Support:
• Support the day-to-day operational needs of the facility.
• Ensure on-time delivery of new products being introduced to Building 20 Manufacturing.
• Champion safety and compliance at all times.

Skills and Attributes:

• Strong project management skills with prior project experience.
• Strong scientific and technical interaction skills with partner organizations.
• Demonstrated technical writing skill.
• Ability to work independently and collaboratively with a high level of initiative and accountability.
• Excellent verbal and written communication skills, with attention to detail and accuracy.
• High level of initiative and accountability, with a proactive mindset.
• Strong analytical, problem-solving, and decision-making skills.

Top 3 Must Have Skill Sets:

1. Project Management
2. Team Player
3. Attention to Detail/Quality Centric Mindset

Day to Day Responsibilities:

1. Owning change controls to introduce new products to the Clinical and Commercial Drug Product Manufacturing facility.
2. Initiate continuous improvement projects.
3. Ensure on-time delivery of new products being introduced to Building 20 Manufacturing.
4. Lead and execute CAPAs and EVs related to Epogen production, ensuring timely completion and documentation.
5. Communicate effectively with internal and external partners.
6. Adhere to all applicable policies, procedures, and standards, such as cGMP, SOPs, and EHS.

Requirements

Qualifications:

Basic Qualifications:

• Master’s degree and 2 years of Manufacturing or Operations experience, OR
• Bachelor’s degree and 3 years of Manufacturing or Operations experience, OR
• Associate’s degree and 5 years of Manufacturing or Operations experience, OR
• High school diploma / GED and 10 years of Manufacturing or Operations experience.
• Degree in engineering, science, or related field, or equivalent combination of education and experience.

Preferred Qualifications:

• Master’s 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.
• Experience with CAPA and EV ownership and execution, preferably using Trackwise or similar quality system.
• Experience with project management tools and techniques, such as MS Project, Agile, Smartsheet.rience