Senior Director, Quality Assurance – Formulation and Fill

Position Summary:   

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help bring biologic treatments to our patients.

As the Senior Director of Quality Assurance for Formulation and Fill at Catalent Biologics, you will assume a strategic leadership role, ensuring the highest standards of quality and compliance within our dynamic and fast-growing business, with a specific focus on formulating biologic drugs for sterile fill/finish processes. This senior-level position provides a unique opportunity to lead a critical function in the development of groundbreaking treatments for conditions such as COVID-19, cancer, autoimmune disorders, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases, and Alzheimer’s.

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

The Role:  

• Provide strategic leadership and oversight for quality assurance activities specific to formulating biologic drugs for sterile fill/finish processes within Catalent Biologics.

• Ensure compliance with company policies, standards, procedures, and regulatory requirements related to sterile fill/finish operations.

• Oversee direct reports and teams to ensure effective review and management of investigations, CAPAs, change controls, and analytical data in the context of sterile fill/finish.

• Play a key role in assisting and providing expertise in the preparation and review of BLA/IND/IMPD regulatory submissions for sterile formulating and fill/finish processes.

• Drive continuous improvement efforts through the reporting, trending, and evaluation of quality metrics data specific to sterile fill/finish operations.

• Collaborate with cross-functional teams to support process optimization and efficiency improvements in sterile formulating and fill/finish.

• Responsible for the hiring, mentoring, and performance management of Formulation and Fill/Finish QA staff with expertise in sterile processes.

• Oversee and ensure the implementation of stringent aseptic practices during all aspects of sterile production.

• Drive improvements in environmental monitoring practices to uphold the highest standards of sterility.

• Provide technical expertise for investigations related to microbial contamination in sterile products.

• Collaborate with cross-functional teams to implement and monitor sterile manufacturing best practices.

• Assess and determine the most suitable sterilization strategy for biologic drug substances considering the instability of most biologics when exposed to heat, radiation, or chemicals.

• Emphasize the preference for aseptic manufacturing, particularly sterile filtration, for unstable biologic products.

• Highlight the challenges of using terminal sterilization methods for biologics, such as heat, radiation, or chemical exposure, and stress the advantages of aseptic manufacturing.

• Emphasize the widespread use of single-use technology in sterile fill/finish operations to reduce turnover time and cross-contamination risk.

• Stress the importance of developing formulations with appropriate viscosity and compatibility with contact surfaces, shear stresses, and sterile filtration processes.

• Explore emerging technologies involving the production of sterile biologics in a powdered state for the creation of sterile suspensions.

• Other duties as assigned.

The Candidate:  

• Bachelor’s degree in chemistry or closely related field (e.g. natural sciences, engineering) is strongly preferred.

• 10-12 years’ directly related experience in pharmaceutical fields including managerial roles.

• Experience with sterile drug product manufacturing and drug substance manufacturing is strongly preferred.

• Experience leading a manufacturing site operation (e.g. Quality Operations, QC Operations, Manufacturing) is strongly preferred.

• Extensive knowledge of Quality Assurance and Quality Control.

• Proven ability to lead a large, multi-level/multi-shift organization (e.g. 50+ employees) effectively.

• Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments.

• Ability to organize time for multiple tasks (major projects and daily functions) and deliver tasks on time.

• Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations.

• 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.