Upstream Process Development Specialist-1 Agency
Texas A&M University Health Science Center Department
Cnt For Innovation in adv Dev & Manufacturing Proposed Minimum Salary
Commensurate Job Location
College Station, Texas Job Type
Staff Job Description
What we believe:
Texas A&M University is committed to enriching the learning and working environment for all visitors, students, faculty, and staff by promoting a culture that embraces inclusion, diversity, equity, and accountability. Diverse perspectives, talents and identities are vital to accomplishing our mission and living our core values.
Who we are:
As one of the fastest-growing academic health centers in the nation, the Texas A&M University Health Science Center encompasses five colleges and numerous centers and institutes working together to improve health through transformative education, innovative research and team-based health care delivery.
What we want:
The Health Science Center (HSC) is looking for an Upstream Process Development Specialist to serve as a member of the CIADM team. We desire an individual who subscribes to and supports our commitment as stated above. The successful applicant will bring an expert level of experience to the position and understand the demands of supporting executives in a fast-paced environment. This person must be professional, enjoy working in a high-volume environment and be able to apply strong organizational skills while being flexible in their daily routine. If this is you, we invite you to apply to become a member of our team. Job Summary:
The position will be responsible for (1) employing and validating robust cellular and viral growth processes for transfer into a manufacturing setting, (2) media evaluation, development and optimization of both cellular and viral production processes, (3) conducting and interpreting bioprocess small-scale development experiments, and (4) maintaining appropriate GLP documentation in support of global regulatory submissions for vaccine licensure. This position will require to work under GLP/GMP to provide high quality, regulatory compliant technical documentation in support of process transfers to manufacturing. Required Education:
- BS in biology-related field with 2 years experience
Required Special Knowledge, Skills, and Abilities:
- BS in biology-related field with 2 years experience
- Expertise in aseptic techniques and the handling and maintenance of mammalian cell lines.
- Experience with cell culture and cell line propagation as well as experience working in a BSL-2 laboratory.
- Knowledge of mammalian cell line development, and nutritional metabolite evaluation.
- Experience with media evaluation, development and optimization.
- Experience with basic molecular biology techniques
- Ability to multi-task and work cooperatively with others.
Preferred Special Knowledge, Skills, and Abilities:
- BS in biology-related field with 5+ years experience
- PhD in biology-related field with 2+ years experience
- Microbiology, or Virology degree
- Experience working with diverse individuals and communities
- Experience in animal health vaccinology.
- Experience with virus propagation and viral process development
- Experience with DOEs and the use of biometrics in bioprocess study design and evaluation.
- Experience with disposable production equipment (e.g. wave reactor systems, S.U.B. reactor systems)
- Experience with cell transfection
- Knowledge of regulatory issues associated with USDA and EU biologics submissions.
- Knowledge of GxPs, including Process validation.
- Master seed production and working knowledge of GMP seed procedures
- Proven record of strong communication and teamwork skills
- Ability to design and analyze multi-factorial biometric experiments
Instructions to Applicants: Applications received by Texas A&M University must either have all job application data entered or a resume attached. Failure to provide all job application data or a complete resume could result in an invalid submission and a rejected application. We encourage all applicants to upload a resume or use a LinkedIn profile to pre-populate the online application.
- Performs advanced project management support for developing and working with onsite and offsite colleagues and to work independently.
- Employs and validates robust cellular and viral growth processes for transfer into a manufacturing setting.
- Responsible for media evaluation, development and optimization of both cellular and viral production processes.
- Conducts and interpreting bioprocess small-scale development experiments for Zoetis projects.
- This position will have experience with bioreactor production systems including disposable single use reactors.
- Maintains appropriate GLP documentation in support of global regulatory submissions for vaccine licensure.
- Provides support to bio-process downstream and analytical scientists.
- Works both with onsite and offsite colleagues and to work independently.
- Plan, and organize R&D projects and establish the required procedures to be applied to those projects,
- Conduct R&D projects,
- Defines problems and provide possible solutions as dictated by R&D projects and protocols,
- Develop and modify equipment and applications as required to accomplish project goals,
- Train and supervise research staff as needed,
- Coordinate and provide technical direction to research staff to ensure effective and cost-efficient completion of projects if needed,
- Provide technical knowledge to research staff to ensure they can complete their assignments,
- Recommend new areas of research and development that support the goals and objectives of our department,
- Analyze, interpret, compile and report project results to a PI and/or department head,
- Serve as a technical liaison between the Cell and Viral Process Development and other partner groups such as Discovery, Clinical, Pilot, Manufacturing and Regulatory,
- Provide finished oral and written communication reports to supervisor and management,
- Work under GLP/GMP to provide high quality, regulatory compliant technical documentation in support of process transfers to manufacturing, and
- Responsible for later stage development and transfer of robust process to Pilot as well as Commercial Production.
- Develops and disseminates work plans and project documents to include procedures, proposals, progress reports, and presentations.
- Prepares and reviews proposals, SOPs, BPRs, reports, QC/QA related documents.
- Maintenance of appropriate documentation for tests, research and development as specified by our department and required laws and regulations.
- Performs other duties as assigned.
In accordance with the federal contractor vaccination mandate, specific facilities at The Texas A&M System may be considered a covered contractor workplace with covered contractor employees. Therefore, successful applicants for this position may be subject to the federal mandate and will be required to be fully vaccinated against COVID-19 as a condition of employment unless an approved medical or religious accommodation is in place.
All positions are security-sensitive. Applicants are subject to a criminal history investigation, and employment is contingent upon the institution's verification of credentials and/or other information required by the institution's procedures, including the completion of the criminal history check.
Equal Opportunity/Affirmative Action/Veterans/Disability Employer committed to diversity.