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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.

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 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.

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Confirmed 20 hours ago. Posted 22 days ago.

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