Upstream Process Development Specialist-2

Job Title

Upstream Process Development Specialist-2

Agency

Texas A&M University Health Science Center

Department

Pharmacy - Instruction

Proposed Minimum Salary

Commensurate

Job Location

College Station, Texas

Job Type

Staff

Job Description

Job Description

What we believe:

Texas A&M University is committed to enriching the learning and working environment by promoting a culture that respects all perspectives, talents & identities.  Embracing varying opinions and perspectives strengthens our core values which are: Respect, Excellence, Leadership, Loyalty, Integrity, and Selfless Service.

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 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.

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 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 Experience:

• BS in biology-related field with 2 years experience

Required Special Knowledge, Skills, and Abilities:

• 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 Education:

• BS in biology-related field with 5+ years experience
• PhD in biology-related field with 2+ years experience
• Microbiology, or Virology degree

Preferred Special Knowledge, Skills, and Abilities:

• 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
• Experience working with diverse individuals and communities

Job Responsibilities

• Responsible for performing advanced project management support for developing and working with onsite and offsite colleagues and to work independently. 
• Employs and validating 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. 
• 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.
• This position will work both with onsite and offsite colleagues and to work independently.
• Plans, and organize R&D projects and establish the required procedures to be applied to those projects,
• Conducts R&D projects,
• Defines problems and provide possible solutions as dictated by R&D projects and protocols,
• Develops and modify equipment and applications as required to accomplish project goals,
• Trains and supervise research staff as needed,
• Coordinates and provide technical direction to research staff to ensure effective and cost-efficient completion of projects if needed,
• Provides technical knowledge to research staff to ensure they can complete their assignments,
• Recommends new areas of research and development that support the goals and objectives of our department,
• Analyzes, interpret, compile and report project results to a PI and/or department head,
• Serves as a technical liaison between the Cell and Viral Process Development and other partner groups such as Discovery, Clinical, Pilot, Manufacturing and Regulatory,
• Provides finished oral and written communication reports to supervisor and management,
• Works 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
• 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.

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.