**Associate Project Lead, Pre-production** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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 (Good Manufacturing Practices) 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 an Associate Project Lead (PL) that 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). The focus will be on understanding client needs and providing excellent customer service and proactive solutions. Under direction from PL team co-ordinate projects from award stage to completion. 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 hourly position: Monday – Friday, 8am-4pm with periodic flexibility for hybrid work schedule.** **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:** + Accurately create Clinical packaging batch records using source documents provided by the Project Manager (i.e. Packaging Summary/Packaging Request/etc.) + Communicating with Project managers any special instructions, revisions, restrictions, documentation requirements, etc. Inserting digital pictures and diagrams to improve the packaging quality on the packaging floor in accordance with SOPs and cGMPs. Interact with Production, Quality Assurance, and Packaging Engineering personnel to communicate project requirements and gather appropriate paperwork for batch records + Create batch records within the timeframe allotted on the project timeline, while balancing other responsibilities and tasks, ensuring right first time. Report any issues that may impact the timelines specified for packaging studies + Calculate drug product and components, as well as checking release status, to ensure ample quantities are available prior to the packaging process. Assign job output material IDs and Lot numbers within current inventory system + Attend project kick-off meetings. Client interaction and communications to facilitate responses to customer questions and provide batch records etc., as required. Onboarding of client supplied drug & components including setting up material IDs, creating onboarding paperwork for receiving & sampling and uploading documents to the Material Tracker (or current tracking system for materials) + Peer review Primary & basic Secondary batch records, as required, for completeness/appropriate documentation and ensuring all corrections to the packaging batch record and label request(s) are corrected accurately prior to submitting for final review + Coordinate Ordering & Receiving activities for Catalent-supplied items related to: requesting/setting up Materials IDs, requesting and creating specifications/methods, submitting purchase requisitions + Other duties as assigned **The Candidate:** + High school Diploma/GED is required with minimum of 1-year of relatable experience in clinical supply, project management, or pharmaceutics. We will also accept a Bachelor’s degree with no experience, but candidates with 1-year of GMP technical writing and/or packaging experience with be favorably considered + Two years of 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. + 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. Positive attitude required + **Physical Requirements:** Individual may be required to sit, stand, walk regularly and occasionally lift up to 30 pounds; ability smell, hear, and talk to communicate orally with customers, vendors, and co-workers. 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 such as computer terminals, calculator, copiers, and fax machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business **Pay:** + The anticipated salary range for this role in San Diego, CA is $65,000 to $74,000 annually. The final salary offered to a successful candidate may vary, 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 (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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 spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .