Director of Fermentation Process Development and Scale-Up

Who We Are:

Antheia is a science and technology company developing next generation plant-inspired medicines. Applying synthetic biology, genomics, bioinformatics, data science, and fermentation, we harness the most beneficial molecules from plants to create active pharmaceutical ingredients in more controlled and economical ways. We are a close-knit team inspired by the possibilities of delivering transformative technologies and breakthrough science to change the course of medicine. We value our people as our most important resource and are always looking for talented individuals who can make valuable contributions to our efforts.

Job Description:
Antheia seeks an experienced Scientist / Engineer to help lead the fermentation scale-up and tech transfer activities at Antheia. A successful candidate will be a strong communicator, effective problem solver, and able to work efficiently in a fast-paced, dynamic environment characteristic of a start-up. The candidate will be capable of working collaboratively with the R&D teams to ensure the processes developed can be cost-effectively scaled to commercial manufacturing level, and effectively communicating realistic timelines and cost considerations. Primary Process Development responsibilities extend to pilot scale planning and execution, tech transfer and scale-up activities, process qualification, deviation management, process monitoring, and post-approval change management to ensure production delivers an uninterrupted and timely supply of commercial products across Antheia's portfolio, meeting all process and product quality requirements. The selected candidate could also be significantly involved in helping develop scale-up and scale-down models for data interpretation and supporting material generation in support of DSP process development work.

The Director of Fermentation Process Development and Scale-up thrives in a diverse and collaborative work environment. Interacting effectively with peers, functional managers, and senior leadership will drive success. You will collaborate closely with R&D, Supply Chain, Quality, the Commercial team, and our global partner CMOs.

Responsibilities:

• Job Description:
  Antheia seeks an experienced Scientist / Engineer to help lead the fermentation scale-up and tech transfer activities at Antheia. A successful candidate will be a strong communicator, effective problem solver, and able to work efficiently in a fast-paced, dynamic environment characteristic of a start-up. The candidate will be capable of working collaboratively with the R&D teams to ensure the processes developed can be cost-effectively scaled to commercial manufacturing level, and effectively communicating realistic timelines and cost considerations. Primary Process Development responsibilities extend to pilot scale planning and execution, tech transfer and scale-up activities, process qualification, deviation management, process monitoring, and post-approval change management to ensure production delivers an uninterrupted and timely supply of commercial products across Antheia's portfolio, meeting all process and product quality requirements. The selected candidate could also be significantly involved in helping develop scale-up and scale-down models for data interpretation and supporting material generation in support of DSP process development work.
  
  The Director of Fermentation Process Development and Scale-up thrives in a diverse and collaborative work environment. Interacting effectively with peers, functional managers, and senior leadership will drive success. You will collaborate closely with R&D, Supply Chain, Quality, the Commercial team, and our global partner CMOs.

  
  Responsibilities:

  • Leads the tech transfer and scale-up of Antheia fermentation processes to commercial scale. This includes working with R&D upstream to design manufacturability into the process to enable flexibility and ultimately success in tech transfer to other sites.
  • Oversee and manage successful operations for pilot and commercial scale runs at external partners in support of product development / launch
  • Defines and manage timelines for fermentation tech transfer to outsourced manufacturing partners
  • Develop TEA models to support cost models for business decisions impacted by engineering changes such as manufacturing scale and process improvements.
  • Assists in process-equipment gap assessments, as well as capital project management necessary for manufacturing tech transfer to external partners.
  • Assist in design of Antheia pilot manufacturing facility as well as potential commercial manufacturing projects
  • Partners with Quality to manage and execute investigation of quality event investigations related to fermentation and the implementation of corrective and preventative actions.
  • Establish and lead failure mode and effect analysis (FMEA) processes/templates to determine which critical processes require validation and at what level of effort. Ensure all needed mitigation plans are in place on time.
  • Develop and utilize scale-down models to predict and troubleshoot large-scale fermentation issues, ensuring seamless scale-up from pilot to commercial production.
  • Oversee and ensure the robustness and capability of manufacturing processes and quality of final products by identifying and monitoring of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs), and oversee the development of data systems to help monitor and report KPI as well as flag process opportunities.
  • Work with manufacturing, quality, and technical staff at Antheia and partner CMOs to prepare and review necessary technical documentation (Process Flow Diagrams, Run Designs, Batch Records, SOPs, OCAPs, CAPAs, specifications, etc.)
  • Serve as Antheia's internal expert on fermentation scale-up and transfer.
  • Implement continuous improvement initiatives: Drive continuous improvement methodologies (e.g., Lean, Six Sigma) to enhance fermentation processes, reduce costs, and increase yield and efficiency at commercial scale.
  • Travel required: up to 15-25%, with some periods of higher frequency, primarily to support European manufacturing operations and domestic manufacturing start-up.
  • Perform other duties as assigned[1]

    [1] This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice.

    Please note that Antheia doesn't discriminate based on age, race, ethnicity, national origin, religion, gender, sexual orientation, disability, medical history, and other non-merit characteristics.

Qualifications/Experience:

• 8-10 years of experience successfully working in a manufacturing fermentation operations environment, with at least five years of managing large, complex cross-functional projects involving large-scale fermentation manufacturing. BS in the relevant Engineering or Life Sciences field discipline is required. An advanced degree (MS or PhD) is a plus.
• Experience with large scale fermentation (>50m³) and tech transfer to Contract Manufacturers of multiple scales in fermentation, as well as commercial manufacturing in various industrial environments from food grade to Pharmaceutical cGMP conditions. In-depth knowledge of upstream and downstream processes, including microbial cultivation, fermentation, harvest, purification required.
• Experience working with other manufacturing functions preferred. These include quality assurance and quality control, supply chain and logistics management, sourcing and procurement, and material and inventory management.
• Exceptional organizational skills with the ability to attain deadlines and prioritize work on multiple projects. Proven experience with project management tools.
• Experience managing internal and external stakeholders.

Additional Information: 

Full-time base salary range of $185,000 - $210,000 (based on Bay Area base salary, will be adjusted accordingly), plus an annual bonus potential and equity opportunities. 

Antheia’s compensation and benefits include:

• Comprehensive compensation package, which includes annual bonus potential and equity opportunities
• Paid time off, in addition to company-observed holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan
• Free access to the Menlo Park Labs Gym
• Menlo Park Labs free shuttle service to CalTrain, BART Station, and SF

Antheia is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Antheia prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire..