Downstream Process Development Specialist

College Station, Texas

Texas A&M University

Job Title

Downstream Process Development Specialist

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 Center for Innovation in Advanced Development is looking for an Downstream Process Development Specialist responsible for performing advanced 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 process development, process scale-up, technology transfer, dead end and crossflow filtration, protein purification, viral inactivation, protein characterization, and operation of automatic purification systems and single-use systems for bioprocessing. This position will be responsible for conducting and interpreting bioprocess small-scale development experiments. This position will be required to maintain appropriate GLP documentation in support of global regulatory submissions. Additionally, they will provide support to bio-process upstream and analytical scientists.

Job Responsibilities:

Plan, and organize R&D projects and establish the required procedures to be applied to those projects, conduct R&D projects, define problems and provide possible solutions as dictated by R&D projects and protocols, and develop and modify equipment and applications as required to accomplish project goals.

Train and supervise research staff as needed and 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 and

recommend new areas of research and development that support the goals and objectives of the department.

Analyze, interpret, compile and report project results to a PI and/or department head and serve as a technical liaison between the Downstream Process Development group and other partner groups such as Discovery, Clinical, Pilot, Manufacturing and Regulatory, and provide finished oral and written communication reports to supervisor and management.

Will work under GLP/GMP to provide high quality, regulatory compliant technical documentation in support of process transfers to manufacturing, and be 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.

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.

Performs other duties as assigned.

Required Education and Experience:

Bachelor of Science degree in biology-related field.

Two-year experience in biology-related field.

Required Knowledge, Skills and Abilities:

Expertise in aseptic techniques and the handling of potentially infectious agents.

Experience working in a BSL-2 laboratory.

Experience with process development, process scale-up and technology transfer.

Experience with dead-end and cross-flow filtration optimization techniques.

Experience with column chromatographic techniques.

Experience with operating automatic purification systems.

Experience with protein characterization.

Experience with basic cell culture and molecular biology techniques

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

Ability to multi-task and work cooperatively with others.

Preferred Education and Experience:

BS in biology-related field with 5+ year experience

MS in biology-related field with 3+ year experience

PhD in biology-related field with 2+ year experience

Preferred Special Knowledge, Skills, and Abilities:

Experience with viral inactivation and viral filtration/concentration.

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

Experience with disposable (single-use) production equipment.

Experience in inactivation techniques and kinetics as well as associated analytical techniques.

Knowledge of regulatory issues associated with USDA and EU biologics submissions.

Knowledge of GxPs, including Process validation.

Ability to work with a high degree of autonomy with meticulous attention to detail.

Proven record of strong communication and teamwork skills.

Ability to design and analyze multi-factorial biometric experiments.

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.

Posted: 01/28/2022