Contract Manufacturing Organization (CMO) Project Manager/Process Engineer

CMO Project Manager/Process Engineer

Elemental Enzymes is looking for a motivated CMO Project Manager/Process Engineer to join our team responsible for the production, technology transfer and optimization of microbial and biochemical products. The candidate will work with a team of dynamic scientists, engineers, and manufacturing personnel as a contributor to the advancement of fermentation and novel chemical & bioprocess approaches. At Elemental Enzymes we are on a mission to develop biological solutions to change the future of agriculture.

The role is centered around production of fermentation-based biological actives, and the downstream processing of fermentation broths, as well as the assay of the biologicals. The CMO Project Manager/Process Engineer, specializing in fermentation, will operate advanced fermentation equipment at pilot and commercial scale to ensure the commercial products are completed right, first time, that are within quality parameters, on time, and at cost. In addition, the CMO Project Manager/Process Engineer will perform and oversee bench and pilot scale fermentations and further downstream processes using a variety of methods such as centrifugation, filtration, and ultra-filtration. In addition, the CMO Project Manager/Process Engineer will have the opportunity to work with non-fermentation CMOs and have responsibility over the non-fermentation-based products.  

Job Description

• Manage production runs at the contract manufacturer organizations (CMOs). Perform and monitor onsite and offsite process performance and analyze data to ensure manufacturing runs are performed accordingly.
• Responsible for batch outcomes regarding safety, quality, costs, and delivery results. Responsible for initiating cross functional working teams, and work cross functionally with quality, safety, process development, regulatory, and supply chain to ensure products are produced and ready for delivery on time, within quality and safety specifications.
• Manage deviations and establish corrections and preventative actions (CAPAs) in collaboration with Quality Manager. Performs proper problem-solving techniques, such as fishbone analysis, 5-whys, etc. to identify root causes to deviations. Performs Plan, Do, Check, Act (PDCA), methods to ensure effective preventative actions are implemented.
• Responsible for production yield and performs batch analysis, including statical process control (SPC) to ensure process in control. In addition, performs other Lean Manufacturing/Six Sigma techniques to improve process reliability and robustness.
• Perform technology transfers at contract manufacturers ensuring right, first time, technology transfer with support of process development team.
• Perform complete production runs including qualification and validation.
• Implementation of established R&D-designed processes and active participation in process development as required during R&D transition to manufacturing.
• Perform downstream processing as required by the SOPs including final formulation steps, in close collaboration with both R&D, process development, quality, and manufacturing teams.
• Thoroughly document and maintain detailed records of processing steps from raw materials to finished product including yield calculations and analysis of results aimed at performance improvements.
• Provide scientific technical support for technology transfer of processes to manufacturing on and offsite.
• Assist with on-site pilot plant activities including all upstream and harvest activities.
• Learn operations of new equipment and procedures to support the growth requirements of the company.
• Participate in writing and/or supporting existing SOPs for manufacturing operations.
• Identify and manage external contract manufacturer relationships and establish technology transfer and manufacturing product transfer plans with contract manufacturers.
• Work with Process Development, Safety, Quality, and Regulatory to ensure contract manufacturers are in compliance with local codes and laws, have a reliable and robust process, and have a strong quality management system.
• Communicate work by preparing effective presentation materials to the larger company audience or external stake holders.
• Audit CMOs when necessary to ensure they are in compliance.
• Create, monitor, and improve performance metrics, KPIs, to manage external contractors.

Required Education, Experience, and Skills

• Individuals with a bachelor’s degree in biology or microbiology, biochemical engineering, chemical engineering, or biotechnology are preferred or those with equivalent education or experience.
• Hands-on experience with microbial fermentation including operation of bench or pilot scale fermenters or bioreactors highly preferred.
• Strong knowledge of microbiology and good aseptic technique is preferred.
• Strong knowledge of chemistry is highly preferred.
• Experience in Wrike project management software and advanced Excel skills desirable.
• Familiarity with computer-controlled equipment within area of responsibility.
• Knowledge of unit operations is highly desirable.
• A minimum of two years of industry experience is preferred with additional active years highly desirable.
• Experience with and an understanding of downstream processing of protein biologicals, including micro- and ultra-filtration is strongly preferred.
• Familiarity with the knowledge to maintain a safe work environment in accordance with policies, procedures, and regulations within area of responsibility.
• Excellent oral and written communication skills. Creativity, problem solving skills, a detail-oriented and meticulous work attitude.
• Mechanical aptitude is a critical skill for this job.

Work Hours & Travel

• Must be able to work off-hours and on weekends to ensure process trials and/or production runs onsite at St. Louis and offsite at contract manufacturers are successfully performed.
• Must be able to travel up to 25%. However, certain months during production campaigns may require more extensive travel, likely through the weekends.

Physical Characteristics

• Reaching: Extending hand(s) and arm(s) in any direction.
• Standing: Particularly for sustained periods of time.
• Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
• Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position. This factor is important if it occurs to a considerable degree and requires substantial use of upper extremities and back muscles.
• Feeling: Perceiving attributes of objects, such as size, shape, temperature or texture by touching with skin, particularly that of fingertips.
• Talking: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
• Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound.
• Repetitive motion: Substantial movements (motions) of the wrists, hands, and/or finger, picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
• Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work.
• Those with this position must be able to work in Biosafety Level 2 Laboratory which can cause more illnesses to those with immunocompromised systems.

Job Location: Flexible with time commitments to St. Louis, MO, United States

Position Type: Full-Time/Regular/Salary/Exempt

Salary: Competitive base range

Benefits: 401K, Healthcare, Dental, Vision, Life Insurance, HSA/FSA Options, Employee Assistance Program, Short-Term Disability, Long-Term Disability, Pet Insurance, Accident Insurance, and Dependent Care Account

About Elemental Enzymes

Elemental Enzymes was founded upon the simple belief that we must do everything we can to improve agricultural performance in a way that not only enables plants to flourish but enriches and renews the planet with eco-friendly and sustainable agricultural solutions. From products that enable effective enzyme, peptide and protein inputs to foliar treatments that hold the promise to renew entire industries, our focus to make a positive difference in the world through people – like you and me. Success is a byproduct of responsible production. That’s why Elemental Enzymes works to bring cross-disciplinary scientists and processes together to create novel solutions to practical problems with a shared goal of helping both the plant and the planet.

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Please complete the application and submit your resume and cover letter to the job opening on our website.