Senior Director, Clinical Operations Position Available In Pitt, North Carolina

Job Description:

Title:

Senior Director, Clinical OperationsLocation:

Harmans,MDPosition Summary:

Reporting to the site VP GM, the Senior Directorof Clinical Operations is a key leadership role at Catalent’sMaryland sites, responsible for driving the strategic direction andoperational success of gene therapy clinical operations. Thisposition involves leading a high-performing, cross-functional teamto ensure the seamless execution of clinical manufacturingprocesses, while meeting both client expectations and internalperformance goals. The Senior Director will leverage extensiveexpertise in clinical program delivery, including manufacturing,technical transfer, project management, and supply chainoperations, to ensure the successful execution of gene therapyprograms. This role is pivotal in cultivating strong clientrelationships, maintaining operational excellence, and workingclosely with site leadership to advance Catalent’s commitment todelivering high-quality, innovative gene therapy solutions.

Withmore than 30 years of experience in biologics services andpartnerships with more than 20 premier gene therapy companies,Catalent is the trusted gene therapy CDMO partner for custom viralvector development and scalable manufacturing of adeno-associatedvirus (AAV) vectors, next-generation vaccines, and oncolyticviruses. We have experience with more than 60 gene therapy programsacross various stages of development, a commercially approvedmanufacturing facility, and a total plasmid and gene therapyfootprint of 600,000+ square feet.

Catalent, Inc. is a leadingglobal contract development and manufacturing organization (CDMO)whose mission is to develop, manufacture, and supply products thathelp people live better and healthier lives. Catalent is dedicatedto delivering unparalleled service to pharma, biotech, and consumerhealth customers, supporting product development, launch, and fulllife-cycle supply. With time-tested experience in developmentsciences, delivery technologies, and multi-modality manufacturing,Catalent supports the acceleration of development programs and thelaunch of more than a hundred new products every year. Powered bythousands of scientists and technicians and the latest technologyplatforms at more than 40 global sites, Catalent supplies billionsof doses of life-enhancing and life-saving treatments for patientsannually.

The Role:

Direct and lead a clinical operations team responsible foroperations, supply chain, manufacturing support teams (MST),project management (PM), and quality assurance (QA) functions,ensuring “right first time” and “on-time” delivery of clientmilestones and programs. Lead and manage multiple teams across clinical manufacturingcampaigns, ensuring continuous and effective 24/7 operations. Demonstrate strong and effective collaboration across allfunctional leaders and teams, ensuring alignment of priorities anddelivering excellence in operational execution. Partner with Human Resources to attract, onboard, develop andretain top talent, ensuring a positive and comprehensive growthexperience for all team members. Lead by example, promoting and upholding organizational valuesand goals to inspire the team. Foster and maintain strong customerrelationships, ensuring high client satisfaction and cultivating a”green” client temperature status to promote repeat business. Partner with Business Development to ensure new program scopesare optimized for successful execution. Engage with clients duringpresentations and throughout the clinical manufacturing process,ensuring seamless communication and alignment with client needs,while proactively addressing any issues. Oversee upstream (direct line resources) and downstream (dottedline resources) clinical production, including protein productionand purification from microbial and cell culture processes, throughbulk drug substance and drop product. Appropriate Ensure KPIs and Operating Mechanisms/Reviews are inplace (eg. Tier process) to provide necessary focus and escalationon all elements of operational performance. Troubleshoot and resolve process and equipment issues, ensuringproactive communication with clients and internal stakeholders.

Develop, revise, and ensure compliance with clinical manufacturingprocedures and specifications, maintaining regulatoryadherence. Ensure the successful technical transfer of clinicalmanufacturing projects in collaboration with the Tech Transferteam, simplifying processes as programs approach commercializationand eliminating deviations. Ensure the implementation of GMP and safety training processes,with an emphasis on cross-training and improving productionrecords. Collaborate with senior management to initiate new clinicalproduction projects, developing strategies to meet contractobjectives and achieve business goals. Communicate departmentalprogress and results effectively through regular governanceprocesses. Forecast and plan clinical activities and resourcerequirements, including developing and maintaining rolling 12-monthforecasts that achieve growth plans.

The Candidate:

B.S. in Engineering or Science discipline and 12+ years of GMPbiologic manufacturing experience OR M.S. in Engineering in aScience discipline plus 10+ years of GMP biologic manufacturingexperience. Some or all of this experience should be in eitherupstream or downstream processing. Manufacturing experience includes mammalian or microbial cellculture and scale-up, the isolation and purification of proteins,antibodies, etc., extensive experience with chromatographyequipment, columns, TFF, CIP procedures, and those processes topurify bulk proteins, antibodies, etc. (HIC, IEX, Affinity). Must have experience in a CDMO or CMO environment and must havesignificant clinical manufacturing experience Minimum of 6 years of leadership experience required Experience with P&L desired Experience with forecasting, project management required Customer facing experience requiredThe anticipated salary rangefor this position in Maryland is $280k – $320k plus variableincentive compensation. The final salary offered to a successfulcandidate may vary, and will be dependent on several factors thatmay include but are not limited to: the type and length ofexperience within the job, type and length of experience within theindustry, skillset, education, business needs, etc. Catalent is amulti-state employer, and this salary range may not reflectpositions that work in other states.

Why You Should Join Catalent:

Defined career path and annual performance review and feedbackprocess. Diverse, inclusive culture. Potential for career growth on an expanding team within anorganization dedicated to preserving and bettering lives. Dynamic, fast-paced work environment. Community engagement and green initiatives. Generous 401K match and Paid Time Off accrual. Medical, dental, and vision benefits effective day one ofemployment. Tuition Reimbursement.

Catalent offers rewarding opportunitiesto further your career! Join the global drug development anddelivery leader and help us bring over 7,000 life-saving andlife-enhancing products to patients around the world. Catalent isan exciting and growing international company where employees workdirectly with pharma, biopharma and consumer health companies ofall sizes to advance new medicines from early development toclinical trials and to the market. Catalent produces more than 70billion doses per year, and each one will be used by someone who iscounting on us. Join us in making a difference.personal initiative.dynamic pace. meaningful work.

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Catalent is an Equal Opportunity Employer, includingdisability and veterans.

If you require reasonable accommodation forany part of the application or hiring process due to a disability,you may submit your request by sending an email, and confirmingyour request for an accommodation and include the job number, titleand location to . This option is reserved for individuals whorequire accommodation due to a disability. Information receivedwill be processed by a U.S. Catalent employee and then routed to alocal recruiter who will provide assistance to ensure appropriateconsideration in the application or hiring process.

Notice to

Agencyand Search Firm Representatives:

Catalent Pharma Solutions(Catalent) is not accepting unsolicited resumes from agenciesand/or search firms for this job posting. Resumes submitted to anyCatalent employee by a third party agency and/or search firmwithout a valid written & signed search agreement, will become thesole property of Catalent. No fee will be paid if a candidate ishired for this position as a result of an unsolicited agency orsearch firm referral. Thank you.

Important Security Notice to U.S.

Job Seekers:

Catalent NEVER asks candidates to provide any type ofpayment, bank details, photocopies of identification, socialsecurity number or other highly sensitive personal informationduring the offer process, and we NEVER do so via email or socialmedia. If you receive any such request, DO NOT respond- it is afraudulent request. Please forward such requests tospam@catalent.com for us to investigate with localauthorities.

California Job Seekers can find our California JobApplicant Notice . #J-18808-Ljbffr