Director of Manufacturing Operations

Miami, FL 33143

Posted: 05/20/2019 Industry: Biotech/R&D/Science Job Number: 48889

The Company:

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

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

The 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.   We empower our

customers’ people, process and products on their journey to commercialization.  

 

The Role:

They are focused on developing novel manufacturing solutions in the cell and gene therapy arenas

and is seeking a Director of Manufacturing Operations to: (1) facilitate the planning and building of a

12, 000 sq ft cGMP manufacturing facility and (2) oversee the production of research grade and clinical

materials.   This Director level hire will ensure materials will be manufactured under GMP practices and will also oversee tech transfer and final process development from the research to the manufacturing

group/customers.

 

Primary Job Responsibilities:

- Oversee the development of Standard Operating Procedures (SOPs) for manufacturing in collaboration

with Development and Quality Systems groups

- Oversee daily RUO and clinical materials production activities

- Ensure raw materials are identified and available and team members are trained and scheduled for

required clinical materials production activities

- Write, review and approve production batch records

- Ensure cGMP compliance through manufacturing oversight and tracking

- Coordinate and facilitate tech transfer and final process development from Research to Manufacturing

groups

- Provide regular production status updates to Executive Management

- Actively participate in planning, building and operationalizing a cGMP facility

- 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 such as sponsors and government agencies

- Build and manage a Manufacturing team, through hiring, training, supervision, mentoring and reviewing of key personnel

 

Primary Job Requirements:

- Advanced degree preferred in an applicable field (Bioengineering, Chemical Engineering, Biological or

relevant process related sciences), with 10+ years of experience

- Extensive cell culture experience required

- Significant GMP manufacturing experience required, with experience in process development and/or

manufacturing of cell therapy products; GMP facility planning and management experience a strong plus

- Strong experience in upstream and downstream cell processing and culture technologies for clinical

materials production

- Strong knowledge of federal requirements for GMP manufacturing and Quality Systems required

(21CFR 210, 211, 820 and 1271)

 

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