Director Biologics Process Development

Location: Oxford, UK

Catalent Pharma Solutions is the leading Contract Development and Manufacturing Organization (CDMO) with comprehensive offerings. Within Catalent, Biologics is a fast-growing business unit focused on providing innovative technologies and product solutions to our clients and patients. Process, analytical and formulation development laboratories in Product Development (PD) support clinical and late phase programs. In addition, the Manufacturing Science and Technology (MS&T) teams in PD support tech transfer and manufacturing operations. Drug Substance (DS) development and manufacturing is accomplished in Madison, WI; Bloomington, IN; and is expanding to our new state-of-the-art facility in Oxford, UK. Drug Product (DP) manufacturing for clinical and commercial products is done in Bloomington, US; Anagni, Italy; Brussels, Belgium; and Limoges, France. We are leveraging our differentiated technology, world class manufacturing capability, and integrated services across the Catalent network.

The Product Development network supports development of biologic modalities (mAbs, novel protein modalities, exosomes, enzymes, viral proteins) from initial early phase through late-stage projects to PPQ and commercial launch. The Development team designs and conducts process and analytical development to define the parameters and conditions necessary to produce high quality drug substance for clinical and/or commercial use.

Using our GPEX CHO cell based system, Upstream Process Development team is responsible for the development and implementation of mammalian cell culture upstream processing methodologies and analytical procedures that can be successfully transferred to cGMP manufacturing to generate therapeutic proteins for human clinical trials. The unit operations, process parameters, and process information to be developed, executed, and transferred include, but are not limited to, seed train scale-up and production bioreactor inoculation specifications and setpoints, specific process parameter monitoring and data collection requirements, media and feeding strategies, and harvest criteria. The process development experiments involved with this research range from high-throughput, Design of Experiment (DoE) formats for clone screening and process optimization to pilot-scale Single Use Bioreactor (SUB) toxicology or engineering non-GMP runs to support cGMP manufacturing.

The Downstream Process Development team is responsible for the development and implementation of downstream processing methodologies and analytical procedures that can be easily transferred to the cGMP Manufacturing team. The process characterization function within the Downstream Process Development group is responsible for the characterization of previously developed or transferred processes heading towards commercial manufacturing.

Responsibilities:

The Director position will work closely with the Project Management, the MS&T group and Operations to ensure successful transfer of processes from PD into manufacturing in order to support early phase through commercial manufacturing activities. The position will also interact closely with prospective and existing clients, as well as Project Management, to ensure client expectations, scheduling, and timelines are met.

Apply technical, functional, business, and/or industry knowledge to design experiments or project scopes; provide scientific or business consultation to the site and executive leadership team and manage multiple functions and/or focuses across site disciplines.

Actively define and execute on the strategic direction of the department by recommending expansion or curtailment of investigations on the basis of experimental results or scientific information.

Lead a group direct reports which may include principal level scientists; people leader reports are expected.

Manage strategic activities across departments and global sites. Define and lead multisite strategic initiatives.

Direct the development of scalable processes to support optimal expression, purification, and product quality attributes for both antibodies, recombinant proteins, or other biomolecules.

Responsible for the execution of production batches and supporting manufacturing up to 2 x2000 L scale in SUBs.

Identify, evaluate, and execute on process improvements to increase existing capabilities.

Other duties as assigned.

Requirements:

· Master's degree in a STEM discipline and >12 years related experience, OR

· Doctorate degree in a STEM discipline and >8 years related experience

· Leadership experience >5 years

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.