Catalent Pharma Solutions Manager, Global Business Operation - Material Categorization in Philadelphia, Pennsylvania

Job Description

Manager, Global Business Operation - Material Categorization

Summary:

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries. https://www.youtube.com/watch?time_continue=1&v=65rz3LwTPX8

The Manager, Global Business Operation is primarily responsible for Product Onboarding (Product Quality & Occupational Toxicology) for all Clinical Supply Services (CSS) Sites via toxicological assessment of API against a qualified Site matrix, working in close partnership with Quality and Regulatory. The Manager, Global Business Operation owns the process and continuous improvement for CSS. The Manager, Global Business Operation collaborates with other similar functions across Catalent to maintain a One Catalent approach to EHS and Quality.

The Manager, Global Business Operations will travel 10% of the time, working directly with CSS Site SMEs and Functional Area Owners. This is a new role to lead a standard process that aligns with Global EHS and QA Policies, to put a One Catalent approach in place for CSS customers that work across multiple CSS sites.

The role of the Manager, Global Business Operations role is critical to the end user which are our patients. It directly affects patients risk and safety if toxicological assessment of API is incorrect. Quality, safety and on-time delivery is a must to be successful in this role!

The Role

Leadership & Communication Responsibilities:

Provides overall toxicological support and service to the Clinical Supply Services business:

  • To maintain employee safety through the control of exposure

  • To maintain patient safety through the control of cross contamination

  • To maintain environmental safety through reducing environmental releases

  • To maintain regulatory compliance with local exposure based legislation

  • Obtain and maintain appropriate qualifications and accreditations to act as the business unit’s expert toxicologist

  • Engages appropriate individuals across the Sites for understanding of responsibilities and actions

  • Client facing role/Customer service mind-set

  • Manages escalations for deliverables impacting project timelines

The Candidate

  • Minimum Bachelor’s Degree in Toxicology or Environmental Sciences is required with at least five years of relevant experience in a GMP regulated environment

  • Have a strong proficiency in a variety of scientific (e.g. toxicological) and technical skills to perform hazard/risk assessment, hazard communication, and other toxicology-based assessments in accordance with compliance to departmental, corporate, and regulatory requirements

  • Have a working knowledge of Standard Operating Procedures (SOPs) and current Good Manufacturing Processes (cGMPs) and their purpose

  • Demonstrated ability to plan and independently implement multiple projects and possess the ability to work under tight and emergent deadlines

  • Excellent written, verbal and interpersonal communication skills, including the ability to present information

Travel Requirements:

  • Travel will typically be less than 10% (once per quarter) with the ability to travel more during certain circumstances

We will identify candidates based on the following:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits:

  • Join a high growth and fast paced organization with a people focused culture

  • Global exposure, defined career path and annual performance review and feedback process

  • Competitive Insurance, 401K, PTO and paid holidays!

About Catalent

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. More products. Better treatments. Reliably supplied. ™

Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.