Director of Process and Product Development

Miami, FL 33143

Posted: 05/20/2019 Industry: Biotech/R&D/Science Job Number: 48887

The Company:

This is a Miami-based startup that will supply primary cells, cell-derived products (conditioned

media and exosomes), and GMP manufacturing solutions to the regenerative medicine industry.

Their vision is to transform a world of cell and gene research to a world of cell and gene therapies.

We cater to the market segments that the major suppliers ignore. They empower their customers’ people, process and products on their journey to commercialization


The Role:

We are seeking an experienced Director of Process and Product Development to lead and

collaborate with cross-functional teams to oversee the production of novel research grade and clinical

materials for cell and gene therapies. This Director level hire will ensure products will be manufactured

under GLP and GMP practices, will oversee tech transfer from Development to the Manufacturing

group/customers and will support Manufacturing and customers with technical support.

Primary Job Responsibilities:

• Lead the Development Team to develop and optimize robust and scalable processes for product


• Develop robust designs for new, custom, or existing products that can be produced costeffectively and according to established project timelines

• Supervise/coach scientists and manage routine team operations

• Define and manage timelines and deliverables of manufacturing process

• Work independently and with a level of functional expertise necessary to influence and execute

technical and project delivery execution

• Design and lead assessment of critical process parameters and process and product


• Collaborate with Quality to establish appropriate critical to quality (CTQ) metrics.

• Write, review, approve technical reports

• Lead and manage technology transfer to Manufacturing. Assist Manufacturing in troubleshooting

production issues on standard and special products.

• Closely work with other functional teams in a matrix organization to move projects forward;

• Plan and manage department budget

• Provide regular production status updates to Executive Management

• Support regulatory filings and inspections as required

• Serve as an SME (Subject Matter Expert) and liaison to senior management, cross-functional

areas and external organizations

• Build and manage a Development team through hiring, training, supervision, mentoring and

reviewing of key personnel


Primary Job Requirements:

• PhD in an applicable field (Bioengineering, Chemical Engineering, Biological or relevant process

related sciences), with 10+ years of industry experience

• Extensive cell culture experience required

• Minimal 5 years of industry experience in process development and/or GLP/GMP manufacturing

of cell and gene therapy products

• Strong experience in upstream and downstream cell processing and culture technologies for

clinical materials production

• Ability to apply scientific and engineering approaches to problem solving and process


• Ability to introduce new technologies to improve and accelerate manufacturing process;

• Deep experience in process optimization, risk assessment, process characterization, validation,

and SOP authoring;

• Strong verbal and written communication skills, ability to manage multiple projects simultaneously

and attention to details, highly organized and self-motivated;

• Management level experience in R&D environment is a strong plus

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