Project Manager

Project Manager

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. 

Catalent Pharma Solutions is San Diego, CA is hiring a Project Manager in Clinical Supplies. The Project Manager will work with our Clinical Services Supply site in San Diego and serves as a liaison between clients and cross functional teams to ensure project success while complying with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The focus will be on understanding client needs and providing excellent customer service and proactive solutions. 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.

This is a full-time salaried position: Monday – Friday, 8:30am-4pm core hours (on-site). 

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Evaluate, identify and develop continuous improvement to processes. Use technical expertise to successfully manage complex projects, mitigate risks and manage issues in timely manner. Development of clinical, stability, and commercial packaging protocols and materials. Develop strategic production plans and timelines. Lead discussions on strategic matters
• Advise clients in packaging and transportation strategic decision making. Ensure key project milestones are delivered timely with quality and integrity. Lead complex client communication. Host client on-site meetings, lead client teleconferences with agendas and meeting minutes and host internal/external project kick-off calls. Participate in internal or client audits
• Understand project contracts and client quality agreements, initiate amendments to both, and bill milestones in timely manner. Forecast M&P (Manufacturing and Production) revenue, and PM (Project Management) revenue to support S&OP (Sales and Operations Planning) and site forecast
• Will become proficient in JD Edwards (ERP), and perform all project set up entries and tracking as needed for all assigned projects and responsible for marking financial milestones. Will review contracts, investigate and propose solutions for disputed invoices to ensure timely resolution and payment
• Coordinate production preparation activities. Create and peer-review project source documentation with client input. Support creation of batch records based on project source documentation including primary, secondary labeling and kitting and assembly
• Develop, train and mentor Associate Project Managers and interact with cross functional teams to communicate project requirements and gather appropriate paperwork for batch records. Item Master identification and creator of request forms, JD Edwards Router, BOM (bill of materials), Purchase Order, and Work Order creation, Clinicopia, and GSA set up. Provide batch record training to production team on complex processes
• Support the creation of Change Orders and drive resolution to changes required during production through client collaboration. Obtain item numbers for labels and randomization copies for batch records
• Coordinate packaging, receiving and distribution activities, related to item master requests, zero-dollar purchase order generation, shipment request completion. Support procurement of needed project materials in timely, efficient and cost-effective manner. Understand and adhere to standard operating procedures (SOPs) in a GMP setting. Address service complaints and associated investigation. Compose deviations and collaborate with QA and Ops Management on Root Cause Analysis (RCA) and CAPA plans
• Other duties may be assigned

The Candidate:

• Bachelor’s degree required. Master’s degree or PMP certificate (Project Management Professional) preferred, but additional experience will be considered in lieu of education 
• Must have a minimum of three years of project management experience in clinical supply or pharmaceutics environment and demonstrated client-facing communication skills 
• Must have successful demonstration of the following: preparation of batch records, packaging, labeling, assembly, supply chain, procurement and distribution of clinical trial materials
• Excellent written and verbal communication skills and internal and external customer service skills required. Must be proactive, with superior time management, organizational skills, and detailed oriented
• Must be 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. Positive attitude
• Physical Requirements: Sit, stand, walk regularly. Able to differentiate colors, read documents, and frequent use of computer monitor and typing. Occasionally lift 0-40 pounds. Accessible to manufacturing floor, office staff, and use required office equipment

Pay:

• The anticipated salary range for this role in San Diego, CA is $95,000-105,000 annually. The final salary offered to a successful candidate, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• 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.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.