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Contract Manufacturing Project Manager

Contract Manufacturing Project Manager

Elemental EnzymesSaint Louis, MO, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Salary :

Contract Manufacturing Project Manager

Elemental Enzymes is looking for a self-motivated Contract Manufacturing Project Manager

to join our team responsible for the production and optimization of microbial and biochemical products. The Contract Manufacturing Project Manager will work with a team of dynamic scientists, engineers, and manufacturing personnel as a contributor to the advancement of 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 and formulation of biological solutions, and the downstream processing of fermentation broths.

Job Description :

  • Manage and develop relationships with strategic external contract manufacturer relationships, acting as single-point owner and understanding their capabilities and capacities
  • Identify and onboard new external contract manufacturer relationships and establish technology transfer and manufacturing product transfer plans with contract manufacturers.
  • Act as Project Manager to the production process, maintaining consistent communication throughout the production process with internal and external stakeholders, including all components of the production, timelines, deliverables, and key metrics.
  • Execute the manufacturing plan with assigned external partners (Providing forecasts, issuing Purchase Orders, processing Work Orders, and vetting invoices for payment).
  • Responsible for batch performance regarding process accuracy, quality, costs, batch metrics, and ERP accuracy.
  • Conduct thorough batch record review to ensure process compliance and production performance.
  • Manage deviations and establish corrections and preventative actions (CAPAs) in collaboration with Quality Manager and external partners. Performs proper problem-solving techniques to identify root causes to deviations. Performs Plan, Do, Check, Act (PDCA), methods to ensure effective preventative actions are implemented.
  • Negotiate sensitive issues with external partners, gathering feedback from all internal stakeholders to ensure optimal outcomes.
  • Collaborate with Product Development to perform technology transfers at contract manufacturers ensuring right, first time, technology transfer with support of process development team.
  • Implementation of established R&D-designed processes and active participation in process development as required during PD transition to manufacturing.
  • Thoroughly document and maintain detailed records of the production process, from planning to product delivery, sufficient for Scorecarding Process, aimed at product and partner performance improvements.
  • Provide scientific technical support for technology transfer of processes to manufacturing on and offsite.
  • Develop in-depth knowledge of external partners capabilities and capacities to best understand production timelines,
  • 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.
  • Audit CMOs when necessary to ensure they are in compliance with process protocols.
  • Create, monitor, and improve performance metrics (KPIs) to manage external contractors.
  • Proactively identify and solve process improvements while maintaining a full workload.
  • Support internal manufacturing process engineering when necessary.
  • Other duties as assigned. The roles and responsibilities for this function may change depending on business needs.

Required Experience :

  • Individuals with a bachelors degree in biology or microbiology, biochemical engineering, chemical engineering, or biotechnology are preferred or those with equivalent education or experience.
  • A minimum of two years of industry experience is preferred with additional active years highly desirable.
  • Extremely detail-oriented work ethic is required for the daily tasks of this role.
  • Relationship management and excellent interpersonal communication skills, with intent of seeking win-win outcomes are required.
  • Must be a self-starter, driven by a results and solutions-oriented mindset.
  • In-depth knowledge and experience of the operations included in fermentation and bioreactors is highly preferred.
  • Experience with GMP processes is strongly preferred.
  • Experience with advanced Excel and Power BI is highly preferred.
  • Experience with an ERP system, specifically NetSuite is a plus.
  • PMP certification is a plus.
  • Work Hours & Travel :

  • Must be able to work occasionally off-hours and on weekends to ensure successful offsite production runs at contract manufacturers.
  • Must be able to travel up to 25%. However, certain months during production campaigns may require more extensive travel, seldom through the weekends.
  • Physical Demands :

  • Stationary Position : Remaining in one position for sustained periods of time.
  • Moving : Moving to accomplish tasks, particularly for long distances or moving from one work site to another.
  • Fine Motor Skills : Using fingers for tasks such as typing, picking, or pinching, rather than full hand movements.
  • Transporting : Moving objects from a lower to a higher position or moving objects horizontally from position-to-position.
  • Manual Handling : Gripping, grasping, or applying pressure to objects using fingers and palms.
  • Operating : Using tools and equipment including a work computer and other office devices such as printers, calculators, etc.
  • Repetitive motion : Engaging in recurring movements of the wrists, hands, or fingers, such as typing or assembling components.
  • 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 sedentary work and the worker is primarily in a stationary position, the job is rated for light work.
  • Physical Requirements :

  • Sensory Touch : Assessing the size, shape, texture, or temperature of objects by touch, particularly with fingertips.
  • Communicating : Expressing or exchanging ideas by spoken word, including providing detailed or critical instructions clearly, quickly, and accurately. Perceiving sound details at normal speaking levels. Alternative methods of communication can be utilized as necessary.
  • Environmental Exposure : The worker is not substantially exposed to adverse environmental conditions and operates primarily in an indoor setting.
  • 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 with match, Healthcare, Dental, Vision, Life Insurance, HSA / FSA options, Dependent Care Account, Employee Assistance Program, Short-Term Disability, Long-Term Disability, Pet Insurance, Accident Insurance, Critical Illness Insurance, Hospital Indemnity Insurance, Long-Term Incentive Plan

    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. Thats 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.

    Apply

    Please fill out the application and attach a cover letter and CV / Rsum. References required upon request.

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    Manufacturing Project Manager • Saint Louis, MO, US

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