Director, Spray Drying Technology Transfer and Scale-up

Director Spray Drying Technology Transfer & Scale-up

Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full life-cycle supply. With time-tested experience in development sciences delivery technologies and multi-modality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Boston-area facility is Catalents global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1 SD4 and SD7 the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions in Chelsea MA is hiring a Director who is an integral part of the senior leadership team with the skills knowledge and experience to advance spray drying programs. The Director is the spray drying subject matter expert responsible for providing scientific technical and operational leadership for all spray drying activities. This position is responsible for a wide range of spray drying activities ranging from technical evaluation of new spray drying programs onboarding new clients scaling-up from laboratory to industrial scale analyzing complex data strategically planning future site capabilities and on-boarding of new manufacturing technologies.

As a leader the Director will enhance and grow the technical and intellectual capabilities of the site to establish spray drying stability while promoting long-term growth. The Director will be a change agent driving a predictable processes and favorable batch outcomes. The Director will lead the team and work in tandem with Project Management team to ensure delivery according to agreements with the clients. The Director will also offer support to Business Development.

Catalent is committed to a Patient First culture through excellence in quality andcompliance and to the safety of every patient consumer and Catalent employee.

The Role:

• Responsible for all scientific strategic project planning and execution aspects of spray drying drug product formulation process development technology transfer scale-up and validation activities based on established goals and project timelines.
• Build and lead the organization to meet the expanding needs of the Catalent-Boston spray drying pipeline which includes dry powders for pulmonary and oral solid dose markets.
• Partner internally and build a best-in-class spray drying team to design and execute phase-appropriate development activities for products ranging from pre-clinical development to routine commercial manufacturing.
• Champion spray drying life cycle management from product development to commercial operations including spray drying process development clinical supply scale-up NOR/PAR and PPQ activities.
• Advance internal spray drying capabilities for formulation drug product development and commercialization of spray drying operations.
• Lead drug product regulatory strategy development through client steering team participation establishment of documentation for regulatory filings and implementing changes to spray drying process to enhance performance.
• Will work cross functionally leading or participating in matrix teams to develop and execute project plans to meet established goals and timelines.
• Will develop the strategic plan for the site spray drying offerings. The Director will build and shape the team as the business expands. The Director will prepare and manage the yearly budget for the team.
• Will interact effectively and transparently with operations and support functions across the site (Quality Assurance Supply Chain Manufacturing Project Management Finance Operational Excellence/Continuous Improvement Commercial Operations EHS Human Resources and Facilities/Engineering).
• Identifies capital investment requirements provides insights for decision-making and supports the business case.
• Other duties as assigned.

The Candidate:

• Leadership experience in Drug Development Process Validation and Commercial Manufacturing.
• Bachelors required. Masters or Ph.D. in Pharmaceutics Chemistry Biological Sciences or other related scientific discipline or equivalent in experience preferred.
• 10 years experience in Pharmaceutical Research and Development with five years in a Leadership role.
• The Director must be on-site at the Chelsea MA (Boston) location with expertise in the inhalation / respiratory / solid dose space.
• Expert knowledge in scientific principles and concepts with a strong consultative but results-oriented approach.
• Advanced analytical skills for data analysis and decision making
• Experienced in all aspects of drug development and lifecycle support including the development of regulatory strategies.
• Works directly with Business Development to win new business (conference calls new customer meetings some travel).
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL GOLD LEAD Now GM Excellence and GROW) may be considered in place of external experience;

The anticipated salary range for this position in Massachusetts is $00. 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:

• Comprehensive Benefit Package (Health Dental Vision & Life Insurance).
• Group Retirement Savings- Registered Pension Plan (RPP) with employer contributions.
• Paid Time Off Programs including Vacation banked time and personal time.
• Employee Reward and Recognition Programs.
• Opportunities for professional and personal development.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 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.

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