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Current positions available:
Director of Operations
Process Development Senior Scientist / Manager (Cell Culture Development)
Quality Assurance Associate (Trainer)
Director of Operations
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Work Days:
M-F Full Time
Responsibilities:
This individual is responsible for all cGMP compliant Manufacturing and Facility Operations including cell culture, bioreactor operations, protein purification and final filling, Facilities and Materials Management.
Key areas of accountability include directing the activities of the responsible upstream and downstream manufacturing departments to assure projects are performed and completed in a manner that is acceptable to clients and GBI; ensures that operations departments follow cGMP, SOPs, and safety procedures as necessary and also ensures that all operations employee are properly trained for their job functions and that the training is documented in CGMP training records. It is expected that this individual will be intimately involved and hands-on activities for all GMP manufacturing, Facilities Operations and Materials Management group.
The Director of Manufacturing Operations will collaborate with Business Development, Process Development, Project Management, RA/QA/QC, and both existing and prospective clients to meet the requirements of each project. This individual will also be responsible for schedules for manufacturing activities and also prepare, review and approve written procedures, SOP’s, batch records, validation and other documents.
Qualifications:
Candidate will have a MS or Ph.D in engineering or biological science or related filed and a minimum of ten years in cGMP biologics manufacturing. Candidate must have a detailed working knowledge and hands-on experience of cell culture, bioreactor production, chromatography, ultrafiltration, and filling operations, and Facilities Operations. Experience in biologics manufacturing, preclinical, Phase I-III clinical manufacturing and/or commercial manufacturing is critical for this position. Knowledge of biologics manufacturing plant design, validation protocols, identification and specification of equipment, and operation are important.
Process Development Senior Scientist / Manager (Cell Culture Development)
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Scope of Function:
1) The transfer of existing Upstream Cell culture processes from client companies into process development and facilitating their transition into GMP production.
2) The design, development and scale up of new cGMP compliant mammalian cell culture and other upstream processes. These processes will consist of perfusion and stirred tank culture methods.
3) The resolution of technical problems and the monitoring of ongoing manufacturing campaigns.
Reports to:
Vive President of Process Development
Specific Duties:
1) Development of bioreactor manufacturing processes utilizing mammalian cell expression systems that meet GMP manufacturing requirements.
2) Development of batch or fed-batch cell culture processes.
3) Development of perfusion cell culture processes using various types of cell retention technologies.
4) Development of stirred tank cell culture processes.
5) Media development and optimization studies
6) Introduction of new processes and technologies into cGMP manufacturing.
7) Interaction with clients to facilitate the transfer of technical information between GBI and the client organization.
8) Good understanding of regulatory compliance and guidelines (e.g. FDA, EMEA, and ICH).
9) Development, planning and execution of pre-GMP scaled process runs/toxicology material.
10) Establish Bill of Materials list for new processes and maintenance of laboratory inventories and equipment.
11) Manage Process development scientists and Laboratory schedules to account for priority changes and project status. Interact with PD downstream to consolidate schedules
12) Record process development activities and results in appropriate notebooks.
13) Technology transfer of upstream processes into production and the training of production personnel. Coordination of activities and communication to assure efficient transfer of projects to manufacturing.
14) Writing and executing design input protocols and design output reports.
15) Writing SOPs and Batch records for newly implemented manufacturing processes.
16) Good verbal and written skills to communicate project status with clients and Project Management as needed.
17) Demonstration of ability to multi-task projects.
18) Interfacing with Sales and Marketing directly with perspective clients in order to facilitate sales.
Education and Skills Required:
Education: BS, MS or Ph.D. in Cell Biology, Biochemical Sciences or Biochemical Engineering
Experience: 5 (PhD) to 8 (BS) + years relevant industrial experience with a proven track record of accomplishments in the design, development and implementation of bioreactor and other cell culture processes. The utilization of molecular biology techniques as they pertain to cell line engineering, monoclonal antibody, and recombinant protein characterization for therapeutic use are a plus.
Skills: Must be able to work independently with minimum direction. Must be able to develop and implement to completion experimental protocols as they pertain to the duties listed above. Candidate must possess excellent interpersonal and communication skills. Intermediate Computer skills are required.
Quality Assurance Associate (Trainer)
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Scope of Function:
Primarily responsible for ensuring compliance as set forth by regulatory agencies- Overseeing the internal training program and providing QA oversight for product manufacturing campaigns.
Reports to:
Manager, Quality Assurance
Specific Duties:
1) Lead the development and management of a comprehensive compliance training program.
2) Enhance training courses to raise quality awareness and improve quality culture across all Operating Units.
3) Coordinate and track training to ensure compliance.
4) Evaluate and implement new and innovative training approaches and other technologies that may be used to deliver training.
5) Oversee the product manufacturing campaigns.
6) Perform reviews for executed Batch Production Records of product intermediates and final product.
7) Assist with technical and compliance issues.
8) Develop, write, and revise cGMP documents.
9) Participate in internal compliance audits.
10) Assist the Head of Department with projects.
Education and Skills Required:
Education: Bachelor’s degree in Life Sciences or a related scientific field.
Experience:At least 3-5 years experience as a trainer. Prior experience in a FDA regulated environment such as pharmaceutical or biologics industry is highly desirable.
Skills: Must be detail oriented with demonstrated organizational and coordination skills.
Outstanding written, verbal and problem solving skills.
Proficient in word processing, power point presentation and computer databases.
Interacts with:
Quality Assurance, Quality Control, cGMP Manufacturing, Project Management, Clients and Consultants.
Please send your cover letter and attached resume to: click here
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