Director, Product Development

Title : Director Product Development

About Catalent San Diego :

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 Catalent San Diego site 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 (Good Manufacturing Practices) manufacturing and stability storage and testing for Preclinical through Phase 2 programs. 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. For over 25 years, the San Diego site has prioritized employee engagement, good science, and creating customer loyalty, resulting in the opportunity for both growth and stability for our team members while we make a real impact for the patients we support.

Summary :

Catalent Pharma Solutions is seeking a dynamic leader to join us as Director, Product Development. The Director, Product Development (PD) is responsible for providing operational, scientific and technical leadership for all product development activities, which includes customer-focused programs and programs based with other Catalent operations. This also includes strategically planning future site capabilities and on-boarding of new development and manufacturing technologies. As a leader, the Director, Product Development will enhance and grow the technical and intellectual capabilities of the site while leading a client-centric team capable of solving diverse problem statements for small molecule and peptide therapeutics. The Director will lead the PD team and work in tandem with Project Management, Analytical Development, Engineering, and Manufacturing teams to assure delivery according to agreements with the clients. You will also offer support to sales (BD) and marketing and emphasize the leadership of development programs with a clear awareness of the site’s Quality & Safety culture.

The candidate should have extensive industry and management experience, as well as in-depth knowledge of formulation of preclinical and Phase I / II oral and / or parenteral formulations and supporting analytical techniques (such as HPLC and physical characterization). Understanding and application of bioavailability enhancing formulation technologies required. Experience with bioavailability enhancing techniques for oral small molecules is important. Current understanding of cGMP regulations is a must. The candidate must be a self-starter, have excellent written and oral communication skills, problem solving and organizational skills. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate.

The Role :

Development and management of 4-8 reports including annual reviews and performance management of all direct reports. Direct reports may also supervise full-time employees. Total group under supervision may include >

20 employees.

Manage department salary budget, hiring / staffing, and training budget.

Final review of work proposals, timelines, reports and system / procedural changes. Lead strategic and tactical scientific discussions with clients and scientific staff.

Proactively suggest solutions that help both our internal teams and our clients meet their objectives.

Provide direction for the development of drug CMC efforts including toxicology and human studies.

Communicate with clients with respect to specific scope and direction of projects, as well as costs and timing of contracted work.

Act as escalation point for client concerns, participate actively in maintaining client loyalty through independent leader-to-leader meetings, business review meetings, and other forums.

Provide progress updates to accounts receivable for client billing.

Represent Catalent by involvement with scientific community through conferences and speaking opportunities. Manage the transfer of projects from development to manufacturing and transfer of projects to external vendors and other Catalent sites.

Review and contribute to proposals / contracts for scientific projects, suggest pricing strategy.

Communicate with Business Development on department status and provide feedback on proposals. Participate in or lead cross-functional teams and projects, such as Quality / Compliance, Continuous Improvement, Safety, and Operations.

Recommend department goals and objectives.Participate in site leadership team activities.

Lead a team that works well with other departments and can be an extension of our external partners.

The Candidate :

PhD in Pharmaceutical related sciences and minimum 11 to 13 years relevant industry experience

B.S. in Pharmaceutical related sciences and minimum of 15 years of relevant industry experience or M.S. with minimum 13 years of relevant experience

Should have broad industry and management experience, with in-depth knowledge of CMC related activities. These may include but are not limited to preformulation, analytical method development (such as HPLC), development of preclinical and clinical oral and parenteral formulations, and phase appropriate quality control activities.

Understanding of cGMP regulations.

The anticipated starting salary range for this role in San Diego, CA is $185,000 to $215,000 annually. 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 :

Defined career path and annual performance review and feedback process

Diverse, inclusive culture

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

Dynamic, fast-paced work environment.

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

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 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 Catalent Careers (https : / / careers.catalent.com / us / en) 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 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.

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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https : / / cdn.catalent.com / files / legal / CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .

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