Associate Project Lead, Pre-Production

Catalent•San Diego, CA

11d•$70,000 - $75,000•Onsite

About The Position

Associate Project Lead, Pre-production (Clinical Supply) Position Summary: Work Schedule: Monday-Friday, core hours 8am-4:30pm 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent’s West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. The Associate Project Lead (PL) will support pre-production teams in the management and successful delivery of assigned Projects for our Clinical Supply site. The Associate Project Lead serves as a liaison between cross functional teams to ensure project success while complying with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). Primary responsibilities of this position include activities related to supply chain, procurement, batch record and label creation, and other project management and coordination activities affiliated with assigned projects. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. The Role: Development of clinical, stability, and commercial packaging protocols and materials. Develop strategic production plans and timelines. Lead discussions on strategic matters Attend client meetings and produce minutes and actions for internal client meetings/teleconferences/client visits and audits to support PL team and understand full scope requirements to generate all required project documentation. Ensure key project milestones are delivered timely with quality and integrity. Generate required documentation and liaise with clients as needed Will become proficient in Enterprise Resource Planning (ERP) system JD Edwards, and perform all project set up entries and tracking as needed for all assigned projects and responsible for marking financial milestones Coordinate production preparation activities. Create batch records based on project source documentation including primary, secondary labeling and kitting and assembly. Interact with cross functional teams to communicate project requirements and gather appropriate paperwork for batch records. Provide batch record training to production team on complex processes Item Master identification and creator of request forms, JD Edwards Router, Bill of Materials (BOM), Purchase Order, and Work Order creation, Clinicopia, and GSA set up. Create Change Orders and drive resolution to changes required during production. Obtain item numbers for labels and randomization copies for batch records. Support Label proof design and label printing Coordinate packaging, receiving and distribution activities, related to item master requests, zero-dollar purchase order generation, shipment request completion. Support procurement activities of needed project materials in timely, efficient and cost-effective manner. Support material onboarding for vendor-procured and client-supplied materials Understand and adhere to standard operating procedures (SOPs) in a GMP setting. Support service complaint investigations Other duties as assigned

Requirements

High School Diploma/GED is required with a minimum of one (1) year of relevant experience in clinical supply, project management, or pharmaceutics.
We will also accept a Bachelor’s degree with no experience, but candidates with one year of GMP technical writing and/or packaging experience are highly preferred
Excellent written and verbal communication skills for client communication and exceptional internal and external customer service skills is required.
Proactive, with superior time management, organizational skills, and detailed oriented.
Able to prioritize, manage multiple tasks and stressful situations.
Able to work independently, as a team, motivate cross functional teams to meet deliverables on time.
Problem solving and solutions oriented.
Focus on quality and integrity with right first-time approach and a positive attitude
Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds; Regular use of telephone and email.
Hearing, vision, and speaking within normal ranges is essential to receive ordinary information and to prepare or inspect documents.
Must be able to visually differentiate colors.
Good manual dexterity for the use of common office equipment

Nice To Haves

Experience with preparation of batch records, packaging, labeling, assembly, supply chain, procurement and distribution of clinical trial materials, pharmaceutical/biotech environment is preferred
Thorough knowledge of systems is preferred – JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS (Electronic Document Management System), etc.

Responsibilities

Development of clinical, stability, and commercial packaging protocols and materials.
Develop strategic production plans and timelines.
Lead discussions on strategic matters
Attend client meetings and produce minutes and actions for internal client meetings/teleconferences/client visits and audits to support PL team and understand full scope requirements to generate all required project documentation.
Ensure key project milestones are delivered timely with quality and integrity.
Generate required documentation and liaise with clients as needed
Will become proficient in Enterprise Resource Planning (ERP) system JD Edwards, and perform all project set up entries and tracking as needed for all assigned projects and responsible for marking financial milestones
Coordinate production preparation activities.
Create batch records based on project source documentation including primary, secondary labeling and kitting and assembly.
Interact with cross functional teams to communicate project requirements and gather appropriate paperwork for batch records.
Provide batch record training to production team on complex processes
Item Master identification and creator of request forms, JD Edwards Router, Bill of Materials (BOM), Purchase Order, and Work Order creation, Clinicopia, and GSA set up.
Create Change Orders and drive resolution to changes required during production.
Obtain item numbers for labels and randomization copies for batch records.
Support Label proof design and label printing
Coordinate packaging, receiving and distribution activities, related to item master requests, zero-dollar purchase order generation, shipment request completion.
Support procurement activities of needed project materials in timely, efficient and cost-effective manner.
Support material onboarding for vendor-procured and client-supplied materials
Understand and adhere to standard operating procedures (SOPs) in a GMP setting.
Support service complaint investigations
Other duties as assigned

Benefits

Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.
Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.
Defined career path and annual performance review and feedback process.
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Several Employee Resource Groups focusing on Diversity and Inclusion.
Competitive salary with bonus potential.
Generous 401K match and Paid Time Off accrual.
Medical, dental and vision benefits effective day one of employment.
152 hours of PTO + 10 paid holidays.
Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
WellHub program to promote overall physical wellness.
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.