2121 Second St. Suite 107B
Industry: Clinical & Scientific
Job Number: 15478
Group Leader, Bio Process Technologies
Seeking an experienced scientist/engineer to lead the Bioprocess R&D team to support microbial fermentation and downstream process development activities. He/she will be part of our R&D team responsible for understanding, developing and improving bioprocesses for new and existing products, transferring processes from R&D to Michigan Manufacturing facility in Bangor, Michigan, and other Contract Manufacturing Facilities.
RESPONSIBILITIES AND DUTIES:
- Overall hands-on experimentation and management responsibility for day-to-day functions of the Fermentation and Downstream Process Development team including directing, mentoring, maintaining and improving all functions of the team members, Process Research Labs and the Pilot Plant.
- Serve as a critical, core functional link between early stage biological development and late stage engineering technology transfer functions.
- Provide hands-on support during technical transfer of manufacturing processes (fermentation and downstream processing) from Davis to MMM and third-party contract manufacturing facilities including visits to third party manufacturing sites when required.
- Collaborate with R&D teams (Formulations, Pest Biology, Plant Biology, Microbiology and Chemistry) to identify novel bioactives and to develop potent and commercially viable/desirable formulations for the microbial end-products for Product Development and Manufacturing functions.
- Advance the physiological process database of novel, industrially useful microbes by applying advanced analytical methodologies including OMICs tools to support the production of highly effective, novel bioactive products for agricultural pest management and plant health applications.
- Apply innovative and advanced analytical bioprocessing technologies to develop scalable and cost-effective bioprocesses.
- Manage and champion the preparation of batch records, laboratory notebooks, technical reports, summaries, protocols, and methods for characterization of microbial production strains and bioprocesses under GLP guidelines to support QC/QA and Regulatory functions.
- Support scale-up of initial production runs of the bioprocesses for new products as well as debug the existing processes, as required by traveling to MMM in Michigan and other CMO sites, as necessary.
- Work with the Supply Chain department for recommending and qualifying raw materials for use in manufacturing.
• Other duties as assigned
Knowledge, Skills, and Abilities
- Hands-on experience with research to pilot scale fermentation and downstream equipment developing practical, reproducible and scalable fermentation and downstream processes.
- Collaborative in a multi-disciplinary team of scientists and engineers to develop advanced knowledge-base of microbes and their bioactivities in a controlled process environment.
- Demonstrated entrepreneurial creativity, innovation, flexibility and accountability to troubleshoot biological and engineering challenges with scale up, yield enhancement and process cost reduction of new microorganisms.
- Knowledge in Design of Experiments-based media development of microbial fermentation to increase biomass yield and the production of secondary metabolites.
- Thorough understanding of microbial physiology of Gram-negative and Gram-positive bacteria, and Eukaryotic microbes.
- Knowledge of classical and recombinant strain improvement programs directed towards improving the properties of the microbial strains.
- Experience in applying directed biosynthesis, fed-batch and continuous culture techniques for improved yields of fermentation processes.
- Experience in Process Analytical technologies-based process development of microbial fermentations to increase biomass yield and the production of secondary metabolites.
- Thorough understanding of analytics and statistics as applied to all processes.
- Experience (minimum 3-5 Years) in downstream processing of microbial products at a manufacturing scale.
- Broad exposure or experience with lab, pilot and manufacturing equipment Experience in technical transfer of processes to manufacturing facilities.
- Demonstrated success in participating with Process Engineering and Process Implementation teams to design and implement manufacturing process from inception to completion.
Required Supervisory Experience
- The candidate must have experience (minimum 5 years) at supervising and motivating technical staff (technicians, scientists, and engineers).
- Management and coaching of the team with attention to the development of required skill sets of the individuals involved
- Must have excellent team building and project management skills.
- Guiding employees with scientific and technical knowledge to navigate through aggressive timelines in a multi-tasking environment.
- Oversight and management of training requirements.
- Technical Oversight of fermentation and downstream process scale up efforts to ensure expected performance.
- Adequate process monitoring including real time review of process parameters and process data/trend analysis.
- Support of the laboratory safety program.
- Adequate knowledge and resolution of operational variances, investigations, Quality and Regulatory Compliance etc.
- Support of audits including walkthroughs, responses, and completion of any suggestions for improvement in internal controls.
- Promotion of a positive, respectful, responsive, innovative and team-based culture.
• A Ph.D. degree in Industrial Microbiology and/or (Bio)Chemical Engineering or related field with a minimum of 5 years of industrial experience in developing processes for industrially useful microorganism-based products including physiology and biochemical engineering principle-based process optimization and scale-up with a minimum of 3 years in leading and mentoring a team of fermentation technicians, scientists and engineers.
Essential Physical and Mental Requirements
Physical Requirements: e.g.,
• Ability to sit at a desk for extended periods.
• Extensive use of computer keyboard, mouse and monitor.
• Ability to lift at least 40+/- pounds.
• Ability to work in a venue such as a Michigan Manufacturing, hotel or other organization’ s meeting room, conference, or convention space; possible inclusion of weekends.
• Overnight travel to annual meetings/conferences (typically up to 7 consecutive days) required; overnight travel to other meetings (typically 1-5 consecutive days); inclusion of weekends may be involved.
• Ability to walk, bend, stoop, kneel, twist, turn and use/walk up ladder/stairs, etc.
• Ability to work with frequent interruptions and changes in workload priorities, ability to prioritize tasks, ability to maintain confidentiality.
• Excellent analytical and organizational skills, able to manage multiple priorities and delegate responsibilities while maintaining quality.
• Independent, energetic and self-motivated individual able to work in a fast-paced team environment with tight schedule.
• Must have strong written and verbal communications skills; responsive; able to work effectively as part of a team.
• Proficiency in good record keeping, writing and revising technical reports and SOPs.
- Excellent technical software skills, including fermentation control and data analysis.
• Experienced in GLP practices and mentoring staff to train and maintain staff for GLP practices.
• Ability to travel by car, train or air either domestically or internationally 1% - 10% of the time; travel 1-2 weeks; 1-7 days out of a month/year, etc.
The above is a list of essential duties and responsibilities for this position. This list is not all-inclusive. This job description may be modified as needed.