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Cell Therapy Manufacturing Manager - The Woodlands Job

Cell Therapy Manufacturing Manager - The Woodlands Job

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Help Wanted: Cell Therapy Manufacturing Manager
Department:
Manufacturing

Reports to:
VP of Scientific Development and Manufacturing

Organizational Relationships:
�Reports to VP of Scientific Development & Manufacturing and works in close collaboration with research and development staff, Quality Systems, and any outsourced services.

�Managerial position: gives direction to lab personnel, works cooperatively with a wide variety of staff and senior management.

Position Overview:
�Responsible for production related operations and assures adherence to the applicable regulations and standards (GMP, GTP, AABB, Quality Systems, OSHA)

�Manage all production activities including planning, training, production processes, budgeting, and reporting
o Accountable for completion of project or product manufacturing goals.
o Continually monitor results for shifts and trends in all processes as well as facility functions
o Overseeing the progression and growth of the technical staff

�Work in conjunction with the Manufacturing Operational Control Supervisor to
o Maintenance of the day-to-day operation and oversight of the manufacturing staff and the GMP facility as well as critical equipment, supplies, and reagents
o Assess and prioritize work schedules in order to achieve the desired milestone across all shifts.

�Review all production records to assure completeness, correctness, and compliance with approved Standard Operating Procedures (SOP) initiating and completing deviations and variances when appropriate.

�Responsible for troubleshooting problems, evaluating root cause, working closely with Quality Systems to monitor performance and quality indicators; and develop, and implement any necessary corrective actions (CAPA) when appropriate.

�Assist in and provide input to critical process decisions

�Provide confidence, stability, leadership, and guidance to the manufacturing group, particularly when unscheduled or unplanned events occur

�Ensures that technical procedures are performed under the highest standards of quality in a timely manner while minimizing costs

�Contributes to the institution�s mission through emphasis on quality, patient focused care, planned change, and cost containment

�Participate in the development of companywide training programs, lab operations, and maintenance processes which are necessary to ensure cGMP compliance.

�Perform the more complex procedures while teaching/mentoring junior staff.

�Other duties as assigned

Skills Required:
Position Requirements:
�In-depth understanding of cell therapy processing of whole blood, aphaeresis, and other cellular products

�Skilled in cell culture and aseptic processing; prefer experience in working with closed culture systems and standard blood banking equipment

�Experience in the production of preclinical, and clinical lots of material in accordance with Batch Production Records and approved SOPs and adhering to the applicable regulations & standards (GMP, GTP, AABB)

�Familiarity with T Cell immunotherapies desirable along with other cell therapy products transitioning from development

�Possess full understanding of procedural scale-up, transitioning of research techniques to production, and of manufacturing operations

�Have a working knowledge of all policies and procedures relating to processes and equipment directly or indirectly involved in the manufacturing of clinical trial material

�Must have prior Supervisory experience

�Ability to effectively communicate directly with senior management, peers, and subordinates and as well as with outsourced service providers

�Ability to work in a multidisciplinary team based environment.

Minimum Education:
�BS in biological science, clinical laboratory sciences, or Medical Technology, and at least 5 years directly related lab experience with strong cell processing and cell culture experience.

Additional Experience and/or Qualifications:
�Must be able to work independently as well as work closely with others and possess solid interpersonal and communication skills. Good oral and written skills are needed to deal with all levels of management, FDA and production employees.

�Good technical and teaching skills, able to make sound judgment, good problem solving skills. Teaching and advisory responsibilities which requires in-depth knowledge and proven experience.

�Capable of working in a fast-paced and often rapidly changing environment

�Able to work independently on off-shifts, capable of handling stress of producing accurate results under time constraints; willing to accommodate schedule adjustments, as well as off-shift and weekend assignments as workload dictates.

�Clinical research experience desirable.
Employment Type:
Employee - Full Time
Contact this Employer »
Employer Information:
Employer:
Opexa Therapeutics
Location:
2635 Technology Forest Blvd, The Woodlands , TX
Employer's Website »
Contact Information:

Date Posted: 2011-01-11
Job ID #: 594
Valid Through: 2011-05-11


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