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Position Summary

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 our customers worldwide. Among its core offerings, Catalent develops and manufactures oral and sterile pharmaceuticals in nearly all major dosage forms while also offering proprietary technologies used in many well-known prescriptions and over-the-counter products.

The Director of Analytical Labs is responsible for the delivery and compliance of a broad spectrum of analytical services encompassing small and large molecules. Services include analytical method development and validation to routine quality control and stability testing.

The Role

• Responsible for technical and operational leadership and management responsibilities for multiple laboratories including:

• Small Molecule Analytical Research and Development

• Solid State Optiform Formulation

• Extractables and Leachable

• Organics and Inorganics

• Compendial and Stability

• Bioassay and Biophysical Characterization

• Plan and lead employee development to achieve performance goals

• Achieve performance for key quality and compliance metrics

• Evaluate and act on internal and external customer feedback to improve measures of customer satisfaction and loyalty at the site level

• Develop and support continuous improvement initiatives to strengthen Catalent’s competitive position in the industry

• Uses regulatory and pharmaceutical industry knowledge to anticipate market trends or modify Catalent offerings

• Provide vision and develop initiatives to improve the site culture and employee engagement

• Prepare budgets and recommend capital expenditures necessary to execute the strategic plan for analytical laboratories

The Candidate

• Bachelors degree required. Masters or PhD in pharmaceuticals, chemistry, biological sciences or other related scientific discipline or equivalent preferred

• 12 years of experience in pharmaceutical research and development

• Minimum of 5 years in a managerial position

• Experienced in aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones. Works directly with Business Development to win new business (conference calls, new customer meetings)

• Expert knowledge in scientific principles and concepts with a strong consultative, but results-oriented approach

• Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings

• Provides reliable/defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies

• Able to lead difficult discussions with customers and drive the conversation to an acceptable resolution

• Accountable to meet business unit revenue targets

• Understand the details of regulatory CMC filing package and the analytical and formulation documentation required therein

• 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

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process

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

• Dynamic, fast-paced work environment

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• GymPass program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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 is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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) .