Job Description
Job Title: Biotech Process Development Associate 3 Location: Oklahoma City, OK
Department: Process Development
Job Type: Full-Time
Position Overview: We are seeking an experienced and highly motivated Biotech Process Development Associate 3 to join our innovative team. This role will focus on advanced process development, optimization, and scale-up of bioprocesses for the production of biologics and therapeutic products. As a Process Development Associate 3, you will work independently and as part of a multidisciplinary team to drive the development of robust, scalable processes while collaborating with other departments to ensure project success. This is an excellent opportunity for a dedicated professional looking to expand their expertise and contribute to cutting-edge research in the biotech industry.
Key Responsibilities: - Independently design, optimize, and execute experiments to advance bioprocesses for upstream and downstream operations, including cell culture, fermentation, protein expression, and purification.
- Lead the development and scale-up of bioprocesses from laboratory-scale through to pilot-scale and provide technical expertise for technology transfer to commercial manufacturing.
- Troubleshoot and resolve complex technical challenges by analyzing process data, performing root cause analysis, and implementing corrective actions.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs, to ensure the successful progression of projects.
- Lead the preparation and review of detailed technical documentation, including experimental protocols, reports, standard operating procedures (SOPs), and regulatory filings.
- Monitor and ensure compliance with industry regulations, including Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA guidelines throughout the process development lifecycle.
- Provide mentorship and guidance to junior team members, helping to develop their skills and knowledge in bioprocess development.
- Plan and execute experiments and process validations in a timely manner, ensuring all milestones and timelines are met.
- Prepare presentations for internal stakeholders and regulatory authorities to communicate process development progress, challenges, and solutions.
- Contribute to the preparation of process development budgets and timelines, and track project deliverables against established goals.
Qualifications: - Bachelor’s degree in Biological Sciences, Chemical Engineering, Biotechnology, or a related field. A Master’s degree or Ph.D. is a plus.
- Minimum of 4-6 years of experience in bioprocess development, preferably within a biotech, pharmaceutical, or biologics manufacturing environment.
- Strong hands-on experience with cell culture, protein expression, purification techniques, and process characterization.
- Expertise in process development strategies for scaling up from laboratory to pilot scale and facilitating technology transfer to manufacturing.
- Proficiency with process analytical technologies (PAT), and experience with mammalian cell culture (suspension/adherent), bioreactor systems, downstream purification equipment, and chromatography techniques.
- Strong understanding of regulatory requirements, including GMP, GLP, FDA, and ICH guidelines.
- Proficiency in data analysis and process modeling using software tools such as Excel, JMP, GraphPad, or similar platforms.
- Strong problem-solving, troubleshooting, and critical-thinking skills with the ability to manage multiple projects simultaneously.
- Excellent written and verbal communication skills, with the ability to convey complex technical concepts to both technical and non-technical stakeholders.
- Proven ability to work effectively both independently and in a team-oriented, collaborative environment .
P
hysical Requirements: - Ability to perform lab-based tasks, including standing for long periods, working with various laboratory equipment, and handling biological samples.
- Must be able to lift and carry equipment, reagents, and materials weighing up to 25 pounds.
Working Conditions: - This position requires flexibility in working hours, including potential shift work, weekends, and on-call duties as necessary.
- Work involves the handling of biological materials.
Why Wheeler Bio?- Opportunity to work with cutting-edge biotechnology in a rapidly growing field.
- Competitive compensation and benefits package.
- Collaborative and inclusive work environment.
- Professional development and growth opportunities.
Job Tags
Full time, Shift work,