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Sr. Director, Product Development - Plasmids DNA

Company: Catalent
Location: Rockville
Posted on: November 18, 2022

Job Description:

Job Title: Senior Director, Product Development - Plasmid DNA

Location: Rockville, Maryland

Position Summary

The Senior Director, Product Development (PD) is responsible for providing scientific leadership and leading the Process & Analytical Development functions for Plasmid DNA and other microbially produced proteins globally with direct oversight for PD groups located in Gosselies (BEL) and Maryland, (USA). These groups are responsible for process development for new and existing products, from early-stage through implementation into production.

The Role

  • Provide technical and strategic department leadership for the timely development of commercially viable and robust manufac turing and analytical processes for site New Product Introductions (NPIs), including technology transfer from the customer, pilot-scale process development, scale-up, and process characterization, with strict attention to timelines.
  • Provides technical sales support in partnership with Business Development, Business, and Site leaders including customer site visits, proposal development, and project meetings
  • Incumbent will play a critical role with Product Development management and Customers during new product development as a direct contact to ensure consistency with operation s and readiness required for new products and technologies
  • Oversee scale-up activities of new products to provide critical client materials (e.g., refence lots), and to ensure commercially viable and robust manufac turing processes and minimize adverse impact on plant operation s
  • Evaluate new product transfers to assure they meet minimum process capabilities, regulatory, and safety requirements
  • Support project management as needed to coordinate various phases of tech transfer process for NPI's, existing products, and new technologies with other departments
  • Provide reports and updates of projects and activities as required for internal, customer and regulatory documentation
  • Provide support and technical leadership for the intra-company and outside 3rd party technology transfers of existing technologies and NPI Commercial / Development Products into the site
  • Support and manage the timely execution of product development activities including engineering and capital spend required for NPI development projects, existing product improvement s, and new technologies
  • Incumbent will work closely with the internal innovation groups to ensure cutting edge capabilities are constantly evaluated and introduced into the PD Department

    The Candidate
    • A Bachelors or Master's degree is required with concentrated studies in Biochemistry or Engineering (or related field) with a minimum of 15 years of relevant work experience, or a Ph.D. degree with a minimum of 10 years of relevant work experience
    • Significant technical/scientific experience in microbial fermentation (upstream/downstream) and, in particular Plasmid DNA with experience also in mRNA production and formulation a plus
    • Strong communication skills (verbal and written), strong presentation skills
    • Experience leading large, global teams
    • Significant experience with production processes and equipment.
    • Experience in contract development and manufac turing is a plus.
    • Must possess exceptional verbal and written communication skills.
    • A strong knowledge of computer systems, including base of Microsoft Word, Excel, Power Point, and Microsoft Projects, in addition to familiarity with statistical software and planning/ inventory systems.
    • Candidate must have working understanding of pharma ceutical drug substance production, c GMP 's, and regulatory guidance relevant to early and late-stage plasmid DNA clinical manufac ture and testing

      Catalent's standard leadership competencies that are used to interview and for Performance & Development:
      • Leads with Integrity and Respect
      • Delivers Results
      • Demonstrates Business Acumen
      • Fosters Collaboration and Teamwork
      • Champions Change
      • Engages and Inspires
      • Coaches and Develops

        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.

Keywords: Catalent, Rockville , Sr. Director, Product Development - Plasmids DNA, Executive , Rockville, Maryland

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