Job Title: Manufacturing & Process Development Technologist
Responsible to: Director of Process Development & Manufacturing
Role: This position will work under the guidance of the Director of Manufacturing & Process Development and perform assigned responsibilities to support the company's product manufacturing process and process improvement initiatives. The Manufacturing and Process Development Technologist will also participate in the evaltation process of innovative technologies and its applicability to the product manufacturing process. This positio will participat in developmental projects that support the strategic initiatives of the company and collaborate closelywith Research and Development associates for daily execution of process development activities.
To support the company's vision, mission and values by demontrating: excellence and competence, collaboration, innovation, respect commitment to our community and accountability.
Primary duties and responsibilities of this role are to participate in product and process development programs for Cell Medica's T-cell therapy platforms and any future technology platforms, including:
- Work as part of a multidisciplinary project to develop innovative technology and product/process improvements in the field of T-cell immunology/immunotherapy.
- Evaluate new techniques and technologies;
- Develop process and product improvements that have commercial applicability, and
- Participate in the assessment of the company’s existing products, technologies and future platforms
- Provide regular updates, data, and applicable documentation to the project team.
- Communicates own work orally and in writing and provides input for scientific reports; and
- Reports and treats data with the utmost regard for integrity and ethics.
- Demonstrate ability to identify issues, offer alternatives, and implement newly recognized courses of action as determined by the team.
- Implement and maintain procedures to ensure compliance with company quality systems, safety systems and technical excellence.
- Maintain comprehensive records of all work
- Writes and formal development reports
- Review development reports
- Generate and maintain necessary batch records, SOPs and process control forms in accordance with company policies.
- Demonstrate technical ability to assist in the design (DOE) and execution of non-routine experiments and procedures with minimum direct supervision.
- Perform immunological assays on â€˜in processâ€™ and final products generated by the process development team to determine impact of process changes on cellular constituents.
- Working knowledge of good tissue culture practices, basic analytical assays such as flow cytometry, ELISpot, sterility assays, bioanalytical assay.
- Understand and apply basic scientific principles with guidance.
- Gain understanding of process quality and offer constructive input into troubleshooting issues.
- Participate in the technical transfer of knowledge, procedures, process improvements and techniques to manufacturing personnel and other appropriate departments.
- Participate in qualification/validation of equipment, assays, processes, etc.
- Other related duties may be assigned to meet business/corporateneeds.
Education and Experience
following are the minimum qualifications and competencies needed to successfully
perform the duties and responsibilities of this position. The individual may be
required to demonstrate proficiency in some of these depending on the
department and/ or job functions assigned.
- Demonstrated ability to work collaboratively as a member of a project team and to communicate effectively with colleagues.
- Strong working knowledge of GTP, GMP,
and GLP guidelines, including direct experience in GMP manufacturing and/or
process improvement in the Biotech/Pharmaceutical industries.
- Strong working knowledge of aseptic
techniques, cell culture techniques, bioanalytical assays, and an understanding
of basic cellular biology
- Working knowledge of the scientific
and technical aspects of T-cell culture is desirable
- Effective oral and written
- Ability to work well under pressure
and meet critical timelines.
justify;text-justify:inter-ideograph;mso-outline-level:1;background:white'>Demonstrated knowledge and application of pertinent or comparable computer
programs, as well as working knowledge of MS Office programs (e.g. Excel, Word).
Education, training and experience
Bachelor’s Degree in medical technology, blood banking or other relevant scientific discipline is required
(3) -Five (5) years equivalent work experience in a related field
- Analyticalâ€”fuses intricate or diverse information.
- Judgmentâ€”exhibits sound judgment and makes timely decisions.
- Planning/organizingâ€”prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
- Problem solvingâ€”identifies and resolves issues in a timely manner, gathers and evaluates information competently.
- Oral communicationâ€”speaks clearly and persuasively in positive or negative circumstances, demonstrates group presentation skills and leads meetings.
- Quality controlâ€”demonstrates accuracy and attention to detail, examines own work to ensure excellence and applies feedback to improve performance.
must be able to stand for 50% of the workday
able to lift a minimum of 35lbs
able to communicate fluently both written and verbally in English
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