Director, Quality Control Analytical

Director, Quality Control Analytical

Position Summary

• 100% on-site

Catalent, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The Director of QC Analytical is responsible for overseeing the Quality Control (QC) strategies and operations, including but not limited to the testing function in support of raw materials, in-process and finished products of Phase I-III and commercial programs. The Director, QC Analytical assures compliance to GMP and company specifications as well as relevant pharmacopeia compendia. The Director identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory. The Director keeps laboratory management informed of all departmental activities and product related events.

The Director, Quality Control Analytical will report to the Head of Quality.

The Role

• Accountable for all activities within the QC Analytical department. Leads the team on the strategies for daily activities of QC Analytical and QC Support Services and assures that job activity deadlines are met on a timely basis. 

• Hires and oversees the training of QC department personnel. Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly. 

• Interacts and communicates with customers to assure expectations are established, agreed to, and achieved. 

• Engage actively with Project Management and other department functions to ensure the GMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer. 

• Identify, maintain, and report functional KPIs to site management. 

• Assures execution of testing programs to assess the quality of raw materials, components, in-process and finished goods, and effectiveness of production processes. 

• Works with leaders to generate new/revise Standard Operating Procedures for analytical test procedures. 

• Other duties as assigned.

The Candidate

• Bachelor’s degree required and 10+ years of relevant experience with 8+years of direct management experience.

• Experience in Analytical testing required.

• Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred.  

• Experience in a GMP environment to include ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance’s (US and EU). 

• Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business).

• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels.  

• Creative individual with excellent problem solving and trouble shooting skills and ability to work effectively under pressure to meet deadlines. 

• 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.

Pay

“The anticipated salary range for this position in Maryland is $188,320 - $258,940 plus bonus. 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 initi