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).

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 role position : Monday Friday, days. Hybrid work schedule (remote / on-site split).

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 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 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 :

• Develop, train and mentor Associate Project Managers and other team members.
• 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.

Provide batch record training to production team on complex processes.

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.

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 preferred) with a minimum of 3+ years relatable experience in clinical supply or pharmaceutics
• Must have strong demonstrated client-facing project management skills
• 3+ years of clinical experience in a pharmaceutical / biotech environment required, with 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
• 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 $67,000 to $135,000 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 with on-site practices as well as regularly participating in Beach Clean-up activities
• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Several Employee Resource Groups focusing on D&I
• 19 days of PTO + 10 paid holidays
• Dynamic, fast-paced work environment
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement Let us help you finish your degree or earn a new one!
• On-site fitness center and wellness programs
• Tuition Reimbursement Let us help you finish your degree or earn a new one!
• GymPass 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety.

The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit 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 .

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]

com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice .

The position of Project Manager II will be based out of San Diego, CA!

Summary

The Project Manager II is responsible for managing moderate complexity project business by placing orders, tracking shipments, and billing the customer correctly.

The Project Manager II owns the relationship with the customer, manages relationships with sales and vendors, and is responsible for maintaining clear and timely communication throughout the project.

For the state of California only, the pay range is $64,480 to $80,000, depending upon qualifications, experience and other considerations permitted by law.

What You'll Do

• Manage all aspects of moderate profile / complex projects that require a strong level of product knowledge
• Communicate to the customer, expedite OS&D's (over, short & damaged) and resolve customer issues promptly
• Read through all Purchase Orders to get an understanding of requirements and makes sure terms and conditions are correctWork with sales and vendors to obtain additional margin when possible
• Coordinate with vendors, customers, and sales teams on pricing, order placement, claims and returned goods, and account management to ensure we are meeting customer expectations
• Expedite backorders to maximize fill rates and customer satisfaction
• Manage the delivery schedule, product quality, information updates and back charge
• Receive day to day requests from the project as well as large packages from the Quotation team
• Provide timely price quotations, requotes, and / or proposals
• Determine vendors and purchase requirements looking for additional pricing advantages and product substitution opportunities to substantially improve the overall profitability of the project
• Coordinate with project team for documentation requirements such as O&M manuals, Test Reports, submittal packages, and Certificates of Compliance
• Other duties as assigned

The information contained in this job description is intended to describe the essential job functions required of those assigned to this job.

It is not intended to be an exhaustive list of all responsibilities, duties, knowledge, skills, and abilities needed to perform the job.

Please note that management retains the right to assign or reassign duties and responsibilities to this job at any time.

The ability to competently perform all the essential duties of the position, with or without reasonable accommodation, demonstrated commitment to effective customer service delivery, integrity, and the ability to work productively as a member of a team or work group are basic requirements of all positions at Rexel USA.

What You'll Need

• High School or GED
• 3+ years of quotation, project management, or customer service experience
• Experience in electrical distribution industry preferred

Knowledge, Skills & Abilities

• Ability to effectively communicate with customers and peers
• Knowledge of Microsoft Outlook, Word, Excel, and Power Point
• Must possess an entrepreneurial spirit, be self-motivated, and enthusiastic about the business
• Must possess the capacity to function effectively and multi-task in a demanding and time sensitive environment
• Must be detail oriented and possess excellent organizational and time management skills
• Must be analytical and able to solve problems
• Ability to drive results

Working Conditions and Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working Environment

• Exposed to unpleasant or disagreeable physical environment such as high noise level and / or exposure to heat and cold - Occasionally up to 20%
• Exposed to bio hazardous conditions - Occasionally up to 20%
• Exposed to toxic or caustic chemicals which mandate attention to safety considerations - Occasionally up to 20%
• Exposed to electrical hazards; risk of electrical shock - Occasionally up to 20%
• Handles or works with potentially dangerous equipment - Occasionally up to 20%
• Travels to offsite locations - Occasionally up to 20%

Physical Demands

• Sit : Must be able to remain in a stationary position - Constantly at least 51%
• Walk : Must be able to move about inside / outside office or work location - Frequently 21% to 50%
• Use hands to finger, handle or feel : Operates a computer and other office machinery - Constantly at least 51%
• Stoop, kneel, crouch, or crawl : Must be able to position ones self to maintain computers in the lab, including under desks and in the server closet - Occasionally up to 20%
• Climb or balance : Must be able to ascend / descend on a ladder - Occasionally up to 20%
• Talk, hear, taste, smell : Must be able to use senses to; effectively communicate with co-workers and clients and detect hazardous conditions - Constantly at least 51%

Weight and Force

Up to 100 pounds - Occasionally up to 20%

Rexel USA (A VEVRAA Federal Contractor), and its affiliated companies, is an EEO / Disabled / Veterans employer. All qualified candidates will receive consideration for employment without regard to any characteristics protected by law.

Job Description

Summary

For location, preferred is San Diego with Franklin Lakes next and then other areas if we need to expand to find the right person.

The Project Manager will be responsible for implementation of commercial strategic initiatives which include experience in CRM (Contact Management systems), Contact Master (master data) in a SFDC / Marketo environment.

The project manager will drive the successful implementations through the adherence to a proprietary methodology and regulatory compliance followed for all systems implementations.

The project manager will be the liaison between the IT and business teams to drive a successful outcome.

Responsibilities

The ideal candidate will bring a combination of strategic understanding, change management experience & exceptional communication & analytical skills together.

10+ years of senior project management using PMBOK guidelines.

Experience with managing projects which include SFDC and Marketo systems.

Experience with managing projects which include working within a master data environment and experience with Rialto and data lake implementations.

Proven track record of collaborating with functional leads to solve complex technical / business problems and presenting solutions to leadership.

Ability to handle ambiguity effectively and manage multiple projects at once in parallel.

Experienced knowledge of project management methodologies such as SDLC, SCRUM, Agile, hybrid and best practices.

Experience working with and managing 3rd party vendors

Experience in managing highly visible projects with multiple workstreams and technology.

Experience with executive level communications written & oral. Establish, maintain, and collaborate stakeholder relationships, expectations both internal and external for the project and organization.

Must be a self-starter with the ability to work independently with minimal supervision.

Demonstrable Resilience, empathy, and accountability.

Proficient in using Microsoft Suite (PowerPoint, Excel, Outlook, MS Teams, MS Project.)

Solid experience in software Implementations in Manufacturing.

Core Competencies, Skills, and Knowledge

Program management concepts

Has technical and practical knowledge of the core Program Management Body of Knowledge (PMBOK®) concepts and principles (e.

g., agile, work breakdown structure, waterfall planning)

Demonstrated experience driving projects from initiation through closure.

Skilled in establishing detailed scope, schedule, resources, and budget using standard project tools (MS Project / SharePoint / etc.).

Experienced establishing Stakeholder management plans, Risk / issue management plans, Vendor management plans and Quality plans.

Experienced establishing and following controls to manage scope change and reporting project schedule / budget performance.

Proactive in surfacing risks and issues. Ability to engage project team and stakeholder community to resolve issues and define risk mitigations.

Stakeholder Relationship Management

Establishes and maintains effective relationships with internal customers.

Is committed to meeting internal customers’ expectations and needs while applying the concepts of objectivity and transparency.

Has technical knowledge and communication proficiency to engage with external customers and suppliers.

Leadership Skills and Presence

Gains support by actively and consistently involving others.

Has an awareness of the audience and cultural and ideological differences and knows how to engage them and have an impact on their decisions and behaviors.

Capable of building a leadership presence that inspires project stakeholders and team members to achieve the project objectives.

Proactive in driving creative resolutions to project issues and risk.

Interpersonal Skills

Experienced in the techniques to work in a virtual / cross cultural meeting environment.

Excellent time management skills. Able to work on multiple concurrent activities and prioritize personal workload and team-work load to optimize project delivery.

Ability to lead effective meetings / workshops. Creating meeting objectives, agendas, and timely distribution of meeting minutes.

Ability to manage meeting discussions to achieve meeting objectives and timeline.

Qualifications

Must haves

5 7 years of project management work experience using PMBOK guidelines.

Preferred

PMP, or other PMI Certification or equivalent

BS in Business Administration, Computer Sciences, Engineering, or related degree that provide foundational skills that foster success in managing projects.

Prior experience working in organizations performing process documentation or implementation of business process outsourcing models.

Primary Work Location

USA CA (San Diego Preferred) or NJ - Hybrid Work model

Summary

For location, preferred is San Diego with Franklin Lakes next and then other areas if we need to expand to find the right person.

The Project Manager will be responsible for implementation of commercial strategic initiatives which include experience in CRM (Contact Management systems), Contact Master (master data) in a SFDC / Marketo environment.

The project manager will drive the successful implementations through the adherence to a proprietary methodology and regulatory compliance followed for all systems implementations.

The project manager will be the liaison between the IT and business teams to drive a successful outcome.

Responsibilities

The ideal candidate will bring a combination of strategic understanding, change management experience & exceptional communication & analytical skills together.

10+ years of senior project management using PMBOK guidelines.

Experience with managing projects which include SFDC and Marketo systems.

Experience with managing projects which include working within a master data environment and experience with Rialto and data lake implementations.

Proven track record of collaborating with functional leads to solve complex technical / business problems and presenting solutions to leadership.

Ability to handle ambiguity effectively and manage multiple projects at once in parallel.

Experienced knowledge of project management methodologies such as SDLC, SCRUM, Agile, hybrid and best practices.

Experience working with and managing 3rd party vendors

Experience in managing highly visible projects with multiple workstreams and technology.

Experience with executive level communications written & oral. Establish, maintain, and collaborate stakeholder relationships, expectations both internal and external for the project and organization.

Must be a self-starter with the ability to work independently with minimal supervision.

Demonstrable Resilience, empathy, and accountability.

Proficient in using Microsoft Suite (PowerPoint, Excel, Outlook, MS Teams, MS Project.)

Solid experience in software Implementations in Manufacturing.

Core Competencies, Skills, and Knowledge

Program management concepts

Has technical and practical knowledge of the core Program Management Body of Knowledge (PMBOK®) concepts and principles (e.

g., agile, work breakdown structure, waterfall planning)

Demonstrated experience driving projects from initiation through closure.

Skilled in establishing detailed scope, schedule, resources, and budget using standard project tools (MS Project / SharePoint / etc.).

Experienced establishing Stakeholder management plans, Risk / issue management plans, Vendor management plans and Quality plans.

Experienced establishing and following controls to manage scope change and reporting project schedule / budget performance.

Proactive in surfacing risks and issues. Ability to engage project team and stakeholder community to resolve issues and define risk mitigations.

Stakeholder Relationship Management

Establishes and maintains effective relationships with internal customers.

Is committed to meeting internal customers’ expectations and needs while applying the concepts of objectivity and transparency.

Has technical knowledge and communication proficiency to engage with external customers and suppliers.

Leadership Skills and Presence

Gains support by actively and consistently involving others.

Has an awareness of the audience and cultural and ideological differences and knows how to engage them and have an impact on their decisions and behaviors.

Capable of building a leadership presence that inspires project stakeholders and team members to achieve the project objectives.

Proactive in driving creative resolutions to project issues and risk.

Interpersonal Skills

Experienced in the techniques to work in a virtual / cross cultural meeting environment.

Excellent time management skills. Able to work on multiple concurrent activities and prioritize personal workload and team-work load to optimize project delivery.

Ability to lead effective meetings / workshops. Creating meeting objectives, agendas, and timely distribution of meeting minutes.

Ability to manage meeting discussions to achieve meeting objectives and timeline.

Qualifications

Must haves

5 7 years of project management work experience using PMBOK guidelines.

Preferred

PMP, or other PMI Certification or equivalent

BS in Business Administration, Computer Sciences, Engineering, or related degree that provide foundational skills that foster success in managing projects.

Prior experience working in organizations performing process documentation or implementation of business process outsourcing models.

Primary Work Location

USA CA (San Diego Preferred) or NJ - Hybrid Work model

Summary

The Project Manager will be responsible for managing all phases of a medium to large size project through construction. Has primary responsibility for budgeting, scheduling, planning, design, specification, and working drawings on a given project.

Resolves architectural problems. Has client contact and authority to direct, control, and monitor all project activities.

Minimum Requirements :

Education : Architectural degree from an accredited university or equivalent demonstrated proficiency.

Experience : Minimum of seven (7) years’ experience in production and coordination of documents in all phases of architectural practice and in management of small projects desired.

Communication and Collaboration

• Listen and communicate effectively and professionally.
• Asks questions about assignments when unclear.
• Has working knowledge and understanding for use of HMC equipment and software.
• Coordinate with team members and consultants for conflicts and discrepancies.
• Ability to apprise supervisor and client for status of work.
• Establish productive working relationships, and deal effectively and cooperatively with clients, team members, consultants, and government agencies.
• Display willingness to make decisions; exhibit sound and accurate judgment; support and explain reasoning for decisions;

include appropriate people in decision-making process; make timely decisions.

• Resolve issues related to team members and consultants.
• Collaborate with appropriate staff to meet goals and objectives of project.
• Coach, mentor, and provide performance-enhancing feedback of assigned team members.

Supervision and Delegation

• Ability to professionally communicate both verbally and in writing to give assignments to office support staff, consultants, and vendors.
• Ability to delegate assignments to support staff and always be respectful.
• Support senior project manager and / or PIC in supervision and delegation of work.
• Be primary source for monitoring employee performance on a daily basis and take appropriate action to report both positive and negative performance.
• Assist and / or prepare evaluations and meet with their personnel to discuss the evaluation.
• Supervise and manage up to six team members for all phases of projects.

Documentation

• Be proficient with HMC’s documentation and office practice systems.
• Write meeting minutes, instruction bulletins, change orders, RFI responses, and professional correspondence for self-managed projects.
• Ability to correspond effectively with agencies, consultants, and clients.
• Assist in review of agreements with clients and consultants.
• Write RFP’S and negotiate contracts and fees with clients and consultants.
• Ability to write and edit specifications.

Business Development

• Always be professional and respectful in interactions with clients and consultants.
• Have complete knowledge and follows HMC procedures, standards, and protocols.
• Have primary role in marketing interviews and writing marketing proposals.
• Maintain primary contact with client and have excellent follow-through with client to help get repeat work.
• Write and develop project marketing interview materials. Participate in project marketing interview.

Management

• Demonstrate motivation in seeking new responsibilities and challenges.
• Set goals, prioritize, and plan work activities for self-management and use time efficiently.
• Estimate hours for assigned tasks and finish tasks within agreed upon budget hours for the task.
• Meet with their personnel to discuss the evaluations.
• Manage projects, budgets, staffing, and coordinate billing.
• Prepare and manage work plans, schedules, budgets, staffing projections, and fees for large projects, and coordinate billing.
• Collaborate with design and production staff, construction administrator, and consultants.
• Work to keep projects within cost-saving measures; contribute to profits and revenues, and use resources effectively.
• Understand contractual liabilities as they relate to projects including fee calculations,
• Monitor and assist their supervisor in the collection of aged accounts payable for the projects.
• Prepare plans of action with their supervisor for resolving project related problems.
• Ensure that project conforms to contractual agreement with client, meeting all set budgets, goals, and work assignments for their project team that clearly defines project expectations.
• Have complete knowledge and follows HMC procedures, standards, and protocols.

Design

• Participate in office design charettes.
• Support design team and ensure that the design intent is followed through all phases.
• Integrate design principles with project design team and maintain design integrity through all phases.
• Promote design quality and design collaboration.
• Collaborate with project design team for programming, planning, and feasibility analysis.

Technical

• Coordinate with government agencies, utility companies, and resolve plan check and approval issues with the agencies.
• Review documents to ensure quality, coordination, and compliance with the requirements of deliverables in all phases.
• Ensure that client standards and all HMC protocols are followed.
• Guide and direct project team and consultants for appropriate materials and systems.
• Review documents for code compliance in all phases and issue code interpretations.
• Review cost estimates and conduct value analysis.
• Review and approve changes in collaboration with the project design team and client.
• Supervise and resolve issues in preparation of construction documents.
• Demonstrate capabilities of Construction Administrator.
• Responsible for the completeness of the specifications.

The salary range for this position is $85,065 - $127,281

The actual offered salary for this position will vary depending on multiple factors including the candidate’s qualification, education, position knowledge, work experience, skills, ability, work location, and internal incumbent compensation for similar roles.

We do not anticipate individuals hired into this position will start at or near the top half of the range listed; the decision will be based on each individual case.

The salary range listed above does not include other compensation elements such as discretionary bonus opportunities, employee stock ownership grants, paid time off, medical insurance, and other wage and benefit opportunities.