Apply on Employer Site

Catalent · 1 day ago

Project Manager

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$95K/yr - $105K/yr

4+ years exp

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO) providing comprehensive clinical supply services. The Project Manager will independently lead project teams in the management and successful delivery of assigned projects and client relationships, ensuring adherence to timelines and quality standards.

BiotechnologyHealth CareManufacturingPharmaceutical

Responsibilities

Coordinate projects from award stage to completion ensuring correct planning timelines are generated, monitored and tracked to ensure successful adherence and completion

Accurately forecast M&P revenue, PM revenue, and supply chain to support S&OP and site forecast process

Lead the implementation of new clinical and/or commercial projects including aspects of material qualification, master batch records, process validation, validation master plan and commercial supply agreements

Utilize and drive Smartsheet/Workfront timeline for day-to-day project activities and become proficient with JD Edwards ERP

Attend and produce minutes and actions for client meetings/teleconferences/client visits and audits to support assigned projects or PM team and understand full scope requirements to generate all required project documentation

When leading commercial projects, determine approach to be utilized, plan and help execute work independently with minimal supervision

Take a lead role in successful and timely launch and subsequent campaigns

Receive, monitor and manage client supplied label text/randomizations, drug, components and materials and ensure delivery to internal functions as required

Generate required documentation and liaise with depot group for 3rd party depot set up

Manage inventory reporting and monitor and track client inventory in line with project requirements

Set up clients on Fusion suite as required

Provide ongoing support for client use and password management

Set up returns phase of projects, generate, manage and monitor inventory reports and destruction process ensuring invoicing is completed

Collect KPI data and provide to internal teams and client

Assist with departmental training and completion of training documentation

Will mentor junior project managers and project coordinators

Will review contracts, investigate and propose solutions for disputed invoices, and effectively manage invoice queries to ensure timely resolution and payment

Assist in the preparation and regular review of Standing Operating Procedures relating to own areas of responsibility

Other duties as assigned

Qualification

Project Management ProfessionalCGMP regulationsProcess validationClinical supply chainCommercial supply agreementsCustomer serviceCommunication skillsTeam leadershipMentoring

Required

Bachelor's Degree and Project Management Professional (PMP) highly preferred. High School Diploma/GED required as a minimum

One (1) year of customer service or client-facing PM role preferred, but ideally four (4) years or more within the pharmaceutical or clinical supply chain field

Preferred experience in leading the initiation of projects in a cGMP regulated industry or validation experience with commercial pharmaceutical projects, knowledge of commercial supply agreements, validation master plans, process validation and rolling forecasts

Physical Requirements: Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently

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.

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees