Director, Downstream Process Development

Proclinical is currently recruiting for a Director of Downstream Process Development with a biotechnology company located in Gaithersburg, MD. As the Downstream Process Development Director, you will be responsible for leading and building a team of scientists/engineering to develop, optimize, and characterize the validatable purification processes for Phase I through Phase III clinical development as well as support of licensure and commercial product.

Job Responsibilities:

• Lead a group responsible for the development of consistent, high-yielding, high-purity, scalable, validatable, and economical downstream purification.
• Demonstrate sound scientific and technical understanding when optimizing a process.
• Identify, apply, and develop new technologies to advance purification capabilities.
• Design, in conjunction with staff, well-thought out experiments using a Design of Experiments (DOE) approach incorporating QbD into the process characterization.
• Assist in scale up, characterization, and optimization of all programs. Provide support for critical operations as needed in our GMP manufacturing facility.
• Responsible for supporting and/or leading process validation activities and strategies including evaluating downstream process characterization plans from process validation protocol creation to report writing.
• Responsible for project coordination and resource management including identification of personnel hiring requirements and skill set gap analysis.
• Participate in tech transfer to other groups and external partners.
• Thoroughly analyze results and methods, troubleshoot processes, generate solutions to problems, and meet regulatory expectations for process development.
• Manage direct reports including Scientists and Engineers at the BS, MS, and PhD levels.
• Manage work assignments for "indirect" report technical staff at our joint venture partner (CPLB) in India.
• Maintain effective communication within process development including cell culture, formulation and analytical as well as QC, Discovery, and clinical functions.
• Prepare and review process development reports, protocols and reports, CMC regulatory filings, and scientific journal publications and presentations.

Skills and Requirements:

• BS, MS or Ph.D. in Engineering, chemistry or biological science with commensurate years of experience. For example, PhD with at least 8 years' experience in pharmaceutical, biologics, and/or vaccine product development is expected at the Director level.
• Strong expertise in process design and development of downstream unit operations with a thorough understanding of chromatography separation and viral inactivation. Experience with products requiring cell lysis, a strong plus.
• Demonstrated ability to improve product purity and yield with economically viable process choices.
• Ability to manage a team of scientists/engineers, and develop and motivate team to achieve results.
• Ability to define priorities and process to get things done.
• Ability to work effectively with cross-functional groups. Experienced in process tech transfer.
• Ability to critically review data and technical reports.
• Strong understanding of FDA regulatory requirements associated with process characterization and documentation of vaccine products.
• Knowledge and expertise in principles and practice of current Good Manufacturing Practices (GMPs).
• Present scientific findings at internal and external meetings.
• Strong people management experience, including leading staff at the various levels.
• Experience in leading managing a laboratory.
• Demonstrated teamwork, organizational, and leadership skills.
• Proven ability to influence across functions and organizations.

If you are having difficulty in applying or if you have any questions, please contact Phil Sawyer at (+1) 617-545-5923 or p.sawyer@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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