Pilot Plant Operations Manager

BioMADE•Maple Grove, MN

20h•$120,000 - $150,000

About The Position

The Operations Manager will lead the operations team at BioMADE’s Maple Grove pilot plant facility. This pilot plant will help bridge a gap in the domestic biotech industry (non-pharma), providing clients with emerging fermentation technologies the ability to demonstrate upstream and downstream processes at a scale which supports future commercial scale design. The Operations Manager will work closely with site process engineers and shift supervisors, laying a foundation to safely and successfully execute client objectives at a high level of excellence. The foundation will require excellent procedures, batch records, training, staff development, and clear communication. The Operations Manager will develop systems which guide operations personnel to execute consistently and safely, empowering success. The Operations Manager will foster a collaborative environment, encouraging team members to use their gifts, talents, abilities, insights, and observations to improve site safety and consistency in operational execution. The Operations Manager will advocate and lead a Zero-Harm safety culture, encouraging full engagement and participation in safety programs and safety culture. Client processes will be operated in a manner to deliver product and data that meet client expectations, building client trust in BioMADE’s capabilities. The Operations Manager reports to the Maple Grove Pilot Facility Manager and will work closely with the site Safety Manager, Quality Manager, Maintenance Manager, Logistics Supervisor, and Process Engineers. The Operations Manager will also work closely with and receive support from members of the Pilot Plant Network.

Requirements

Minimum of 3 years in one of the following roles for a biotechnology based organization (pilot scale, commercial scale, or CDMO)
Shift supervisor or operations manager, supervising a team of at least 4
Upstream or Downstream process engineer closely tied to supporting operations or process development supporting technology transfer
Education. B.S. in Chemical Engineering, Biochemical Engineering, or Mechanical Engineering preferred. If candidate is not degreed, will consider candidate who has demonstrated a strong work history in biotechnology based organizations (pilot, commercial, or CDMO) in either operations or process development.
Clearly demonstrate a strong working knowledge of upstream and downstream systems commonly utilized in biotech

Responsibilities

Work closely with Safety Manager and Facility Manager to develop and implement site safety policies and permits, ensuring operations personnel receive and understand required training.
Advocate a Zero Harm safety culture and an environment of continuous improvement
Openly discuss and understand team members safety concerns, and develop plans to address the concerns in a timely manner.
Strongly advocate Job Safety Analysis and Pretask briefs with clear stop work criteria.
Lead the development of training documents and training programs for all unit operations, building on fundamental principles towards a more advanced understanding of the equipment as well as integrated operations. Training documents should not only prepare personnel for standard operations but also prepare personnel to understand the causes of upset conditions and effective response.
Develop a training and qualification pathway for operations personnel, advancing their knowledge, understanding, and level of responsibility for upstream operating systems, down stream operating systems, and utility support systems.
Lead the development of training documents on design and operational strategies used to achieve aseptic operation in the fermentation area, ensuring team members understand these strategies.
Ensure personnel are trained on process flows and protocols for each specific client, with clear expectations for support if deviations occur which could impact meeting client objectives
Lead the development of SOPs, batch records, checklists, troubleshooting guides, data displays, DCS displays, etc that will serve as tools to equip and empower personnel to consistently succeed in a technically demanding environment.
The Operations Manager will directly lead a team of shift supervisors. The Operations Manager will establish clear roles/responsibilities/expectations for shift supervisors.
Operations Manager will be responsible for establishing the production schedule, ensuring the team and plant equipment are ready to execute against said schedule. The Operations Manager will also be involved in troubleshooting efforts when equipment and processes deviate from normal conditions.
Maintenance and Reliability: The Operations Manager will work with the Maintenance Manager to ensure the Operations Team supports preventive maintenance plans and reactive maintenance for plant assets. Operations Team members will be trained on and use maintenance software to generate work requests in accordance with protocols established by and agreed upon by the Operations and Maintenance team.
Logistics: The Operations Manager will communicate the production forecast with the Logistics Supervisor ensuring raw material inventories are adequately maintained to support the production schedule.
Environmental: Ensure Operations team remains compliant with all site environmental and waste water permits.
Food Safety: The Maple Grove site could produce food grade products to support client applications testing. The Operations Manager will support the Quality Manager to implement required plant sanitation programs, food safety and food defense programs, and will maintain the Operations Department ready for food safety audits.
Quality: The Operations Manager will work with the Quality Manager to ensure batch documentation and client finished goods adhere to approved standards.
Other duties as assigned by Facility Manager

Benefits

BioMADE provides a comprehensive suite of health insurances, supplemental benefits, and paid time off to all regular full-time employees as outlined below. Additional benefits include:
100% employer-paid options for medical, dental, and vision
Paid time off that accrues from your hire date
13 paid holidays, including a winter closure between Christmas Eve and New Year’s Day
Hybrid work policy for most positions; stipend for internet and personal phone use
401(k) retirement plan with up to 6% match on compensation (no vesting period!)
Discretionary Incentive Plan based on organizational and individual performance
100% employer-paid short-term disability and life insurance
Paid parental leave
Section 125 Flexible Spending Plan for medical and dependent care
Commuter pre-tax benefit
Full access to LinkedIn Learning’s suite for professional development
Free parking, casual dress code, free snacks and beverages, and on-site gym access at both offices
Fun on and off-site employee activities sponsored by the Employee Engagement Committee
And much more
We nurture merit, talent, and achievement by supporting equal opportunity and welcome people of all backgrounds and beliefs to join us in our mission to enable domestic bioindustrial manufacturing at all scales. Come join our team!