Upstream Process Development Specialist I

Job Title

Upstream Process Development Specialist I

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 schools 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 I to serve as a member in the Center for Innovation in Advanced Development and Manufacturing (CIADM) team. We desire an individual who subscribes to and supports our commitment as stated above. The successful applicant will bring their experience to the position and understand the demands of supporting the department 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.

The Texas A&M University Health CIADM program operates the Transboundary Emerging Disease facility for Zoetis Inc. While officially working at the TED facility, you will also be a subcontractor to Zoetis (an American drug company and the world’s largest producer of medicine and vaccination products advancing the care for pets and livestock) and have the opportunity to work on vaccine programs that may ultimately be produced at one of their many facilities.

Job Description

The Upstream Process Development Specialist I is responsible for (1) performing projects for developing production processes and produce recombinant proteins, restriction enzymes, monoclonal antibodies, viral materials, bacteriophages, stem cell materials, and DNA/RNA molecules for preclinical through human Phase I clinical trials. This position will also be responsible for (2) developing robust microbial, cellular and viral growth processes for large scale production of preclinical and phase I clinical materials, (3) media evaluation, development and optimization of both cellular and viral production processes, and (4) conducting and interpreting bioprocess small-scale development experiments for PD and GMP production projects.

Required Education:

BS in biology-related field or equivalent combination of education and experience

Required Experience:

None

Preferred Education:

BS in biochemistry, biotechnology, microbiology, or virology

MS in biochemistry, biotechnology, microbiology, or virology

PhD in biochemistry, biotechnology, microbiology, or virology

Preferred Experience:

Two years of biotech industrial experience

Experience with cell culture and cell line propagation as well as experience working in a BSL-2 laboratory.

Experience with basic molecular biology techniques

Experience with media evaluation, development and optimization.

Experience with virus propagation and viral process development

Experience with DOEs and the use of biometrics in bioprocess study design and evaluation.

Experience with production equipment (e.g. stainless steel fermenters, wave reactor systems, S.U.B. reactor systems)

Experience with cell transfection

Required Licenses and Certifications:

None

Preferred Licenses and Certifications:

None

Required Special Knowledge, Skills, and Abilities:

Expertise in aseptic techniques and the handling and maintenance of mammalian cell lines as well as microbial cell lines (E. coli, yeast, etc).

Knowledge of mammalian and microbial cell line development, and nutritional metabolite evaluation.

Maintain laboratory notebooks and records in accord with scientific protocol and applicable Standard Operating Procedures.

Ability to multi-task and work cooperatively with others.

Preferred Special Knowledge, Skills, and Abilities:

Knowledge of regulatory issues associated with FDA and/or 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

Job Responsibilities

Research & Development

Responsible for performing  projects for developing production processes and produce recombinant proteins, restriction enzymes, monoclonal antibodies, viral materials, bacteriophages, stem cell materials, and DNA/RNA molecules for preclinical through human Phase I clinical trials. This position will be working with intramural and extramural collaborators and team members to conduct contract research and development manufacturing operations for public, private and academic organizations. This position will be responsible for developing robust microbial, cellular and viral growth processes for large scale production of preclinical and phase I clinical materials.  This position will be responsible for media evaluation, development and optimization of both cellular and viral production processes.  This position will be responsible for conducting and interpreting bioprocess small-scale development experiments for PD and GMP production projects.  This position will be required to operate fermentor and bioreactor production systems including disposable single use reactors.  This position will be required to maintain appropriate GMP documentation in support of FDA Investigational New Drug submissions for testing drug safety and efficacy in phase I/II clinical trials.   Additionally, this position will provide support to bio-process downstream and QC team members.

This position will also need:

To assist with planning, and organizing R&D projects and establish the required procedures to be applied to those projects. To assist conducting R&D projects.

To define problems and provide possible solutions as dictated by R&D projects and protocols. To develop and modify equipment and applications as required to accomplish project goals. To coordinate and provide technical direction to research staff to ensure effective and cost-efficient completion of projects if needed. To provide technical knowledge to research staff to ensure they can complete their assignments. To recommend new areas of research and development that support the goals and objectives of our department. To analyze, interpret, compile and report project results to a PI and/or department head.

To serve as a technical liaison between the Cell and Viral Process Development and other partner groups such as Discovery, Clinical, Pilot, Manufacturing and Regulatory. To Provide finished oral and written communication reports to supervisor and management. To work under GLP/GMP to provide high quality, regulatory compliant technical documentation in support of process transfers to manufacturing. To be responsible for later stage development and transfer of robust process to Pilot as well as Commercial Production.

Documentation

Develops and disseminates work plans and project documents to include procedures, proposals, progress reports, and presentations.

Preparation and review of 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.

Other Duties

Performs other duties as assigned.

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.