Senior Manager, Formulation Development

Catalent

Saint Petersburg,FL  

2019-09-26 2019-10-26
manager administration 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











Senior Manager, Formulation Development







Position Summary











St. Petersburg is our primary Softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year.  Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. 







Are you looking for an opportunity to utilize your engineering leadership skills to ultimately hep patients live better healthier lives? We want to hear from you!







Our Senior Manager of Formulation Development reports directly to the Director, Formulation Development and is responsible for leading a team that develops lipid-based and hydrophilic pharmaceutical formulations (including Softgel, OptiShell® and oral liquids), and execution of associated pre-formulation and formulation development activities for globally regulated pharmaceutical products. This scope of work applies to both new products (NPI’s) and existing products, from early-stage development through implementation into commercial production. This position leads a team including, but not limited to, Product Development Scientists, Sr. Scientists, Lab Technicians and Product Development Interns.







The Role









+ You will be responsible for maintaining appropriate staffing, onboarding, training and development of personnel within the team to meet the team’s function as described above and to maintain accountability against each individual’s goals and objectives.



+ You will provide support and technical leadership for the timely development of commercially-viable and robust formulations for site New Product Introductions (NPIs), including pre-formulation activities, fill formulation development, shell selection or development, prototype manufacturing and clinical/registration batch manufacturing, based upon agreed upon project timelines.



+ You will support and manage the timely execution of product development activities including engineering and capital spend required for NPI development projects, existing product improvements, and development of new technologies.



+ You will train team members on fundamentals of pharmaceutical product development and formulation development principles.



+ You will work cross-functionally and collaborate with other departments at the site, including but not limited to Operations, Quality Assurance, Analytical R&D, Quality Control, Validation, Engineering, EH&S, Supply Chain, Finance, HR, and Procurement.



+ You will review and approve technical documents (new formulations, reports, batch records, protocols, regulatory filing documentation, design drawings, and laboratory instrument qualification).





The Candidate





+ A Master’s Degree or Doctorate (PhD) degree is required within the fields of Chemistry, Pharmaceutical Sciences or Chemical Engineering



+ Minimum of 8 years relevant work experience with a PhD or a minimum of 10 years of relevant work experience with a Master’s Degree (preferably within the pharmaceutical industry).



+ Experience directly managing people for at least 3 years (preferably >3 years).



+ Extensive knowledge and experience in research and development activities relating to successful design and development of new pharmaceutical products within a Quality-by-Design framework and GMP compliant manufacturing processes.



+ Significant experience with pilot-scale manufacturing (both experimental and GMP) and production processes and equipment.



+ Experience in contract pharmaceutical development and manufacturing is desirable.



+ Must have well-developed people skills and be able to apply a combination of leadership, performance management, scientific knowledge, judgment, time management, delegation and realistic appraisal in varied situations.



+ Must possess excellent communication skills (written and oral) and PC skills. A knowledge base of Microsoft Word, Excel, Power Point, and Microsoft Project is desirable.



+ Strong understanding and expertise in pre-formulation and formulation development, advanced analytical instrumentation, cGMP’s, and regulatory issues as they apply to pharmaceutical product development.





Position Benefits









+ Cross functional exposure to other areas of Operations



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



+ 152 hours of paid time off annually + 7 paid holidays









We will identify candidates based on the following Catalent Competencies









+ Leads with Integrity and Respect



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ Engages and Inspires



+ Coaches and Develops

















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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