Senior Scientist, Team Leader - QCCA

Catalent

Morrisville,NC  

2019-11-19 2019-12-19
pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



Job Description

Position Overview:



Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here











Position Summary



The QCCA team performs analytical testing for API, excipients, and drug products. This fast-paced group is integral to our Patient First philosophy, ensuring patient safety through rapid and accurate verification of critical characteristics. As a Senior Scientist, Team Leader your experience will be leveraged to drive technical and quality excellence within a high-performing team. The Senior Scientist, Team Leader will direct the daily work of analysts with different levels of experience and interact regularly with external customers and internal support groups.







Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures and packages pharmaceutical and other products for customers in nearly 100 countries, employs approximately 8,000 employees at 30 facilities worldwide and generates more than $1.7 billion in annual revenue. Among its core offerings, develops and manufactures oral and sterile pharmaceuticals in nearly all major dosage forms, and offers proprietary technologies used in many well-known prescriptions and over-the-counter products. Catalent is also the largest contract packager of pharmaceuticals.







The Role





+ Plan, conduct, and supervise assignments involving the identification, assessment, and development of new scientific concepts and technologies



+ Reviews progress and evaluates results



+ Plans and assigns personnel for given projects or tasks



+ Recommends changes in procedures



+ Develop and execute laboratory workplans/schedules for self and junior members of team, using customer milestones and Division/site performance standards and metrics



+ Review technical documents for accuracy, thoroughness and regulatory compliance



+ Trains, coaches or mentors others on technical, personal development or business issues



+ Supervises technical staff, including work assignments and performance and development management









The Candidate





+ Extensive experience in Compendial (USP, EP, JP) methods and the associated regulatory expectations



+ An extensive understanding of wet chemistry techniques and chemical handling is required



+ Chromatography experience (LC, GC, IC) is preferred



+ Experience in a GxP environment is required



+ Management experience is required





Education or Equivalent: Doctorate’s degree with more than 4 years related experience or, Master’s degree with more than 8 years related experience, or Bachelor’s degree with more than 10 years related experience



Experience:







Knowledge/Skills Requirements:









+ Advanced project management skills are routinely practiced for multiple concurrent projects of moderate complexity



+ Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs



+ Ability to learn and retain technical information



+ Advanced project management skills are routinely practiced for multiple concurrent projects of moderate complexity



+ Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones



+ Can provide reliable/defendable interpretations of regulatory guidances for the customer









Catalent’s standard leadership competencies





+ Leads with Integrity and Respect



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ Engages and Inspires



+ Coaches and Develops









Position Benefits





+ Medical, Dental, Vision and 401K are all offered from day one of employment



+ 19 days of paid time off annually



+ Potential for career growth within an expanding team



+ Defined career path and annual performance review and feedback process













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 www.catalent.com/careers to explore career opportunities.











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, 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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





Catalent = Catalyst + Talent







Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!







personal initiative. dynamic pace. meaningful work.







Catalent is the perfect place to grow your career if…





+ You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).











+ You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!











+ You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.











+ You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.











+ You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!











+ See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.











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.
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