VP, Technical Operations

Job Description:
Antheia is hiring a Vice President of Technical Operations. Reporting directly to the Chief Operating Officer (COO), this role will be responsible for managing the scale-up and tech transfer of Antheia’s products to manufacturing partners, working with R&D functions to develop product / process development plans and timelines. A qualified candidate will be strong in process development and scale-up, fermentation-based manufacturing with small molecule DSP, and process engineering. The 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. As the operations team is the critical gateway to product launch, the leader in Technical Operations must be a technical partner to the R&D organization and a key partner to commercial and business development, able to provide the requisite techno-economic analysis (TEA) to support sound decision-making for the business. This business leader will have the opportunity to lead multiple exciting projects building out pilot scale and large-scale commercial manufacturing operations in the United States from project genesis.

Responsibilities:

• Owns the tech transfer and scale-up of Antheia processes to commercial scale. This includes working with the R&D team upstream to design manufacturability into the process to enable flexibility in tech transfer to other sites.
• Oversees the implementation of U.S. manufacturing infrastructure development and implementation, ensuring the establishment of facilities that comply with regulatory standards and align with company’s expansion goals.
• Drives the manufacturing site selection process by maintaining a stable network of capable partners and guiding the business through technical capabilities / business match.
• Manages all internal responsibilities for manufacturing, manufacturing sciences and technology (MSAT), engineering, and oversees the development of future internal pilot scale manufacturing.
• Partners with leadership on cross-functional teams to deliver and maintain processes and controls that are timely, phase-appropriate, and compliant, to meet scale.
• Ensure that each group has appropriate protocols to support tech transfer including process development, QA/QC, and regulatory.
• Assists in process equipment gap assessments, as well as capital project management necessary for manufacturing tech transfer to external partners.
• Manages manufacturing engineering activities to ensure quality, cost, and customer service goals are met.
• Effectively builds organizational capacity necessary to achieve functional objectives and organizational goals, including recruiting and developing strong scientific and technical talent with a diversity of skill sets.
• Initiates programs to identify improvements for process reliability, manufacturing yield, product quality, efficiency, and customer service, including reducing operational costs such as labor, materials, energy, and processes.
• Coordinates investigation of quality events with QA and R&D and oversees completion of any necessary corrective actions to remediate.
• Provides support and guidance to the leadership team and review business development opportunities where there is a good alignment between a critical business need and group talent, skills or abilities.
• Regularly communicates strategic and technical information that may affect major business segments and/or functional activities.
• Organizes and presents plans in a compelling manner to gain acceptance from target audience.
• Actively promotes safety culture and awareness. Always demonstrates good safety practices, including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
• Performs other duties as assigned[1]

Qualifications/Experience:

• Advanced degree or PhD in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or related field.
• Minimum of 15 years’ experience in biopharmaceutical/pharmaceutical manufacturing environment, with a minimum of 5 years’ senior management experience.
• Experience in early and late-stage product development, ideally having successfully been involved with bringing a product(s) to market.
• Experience leading technical groups to establish and achieve business objectives.
• Experience working in a CMO environment for manufacturing bio-derived products.
• Experience managing technology transfer projects.
• Position may require up to 20-30% travel.
• Strong project management skills and experience, including process and equipment design, installation, or major modification.
• Experience interacting with government regulatory agencies is a plus (FDA, DEA, etc).
• Strong organizational and communication skills.
• Effective problem solving skills.

Additional Information:

Full-time base salary range of $240,000 - $285,000, plus an annual bonus potential and equity opportunities.

[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.

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.