• Contribute to the antigen production and process validation at CDMOs for Phase 3 clinical studies and commercial supply.
• Contribute to regulatory filing and creation of policies and procedures to ensure compliance with the US Food and Drug Administration's (FDA) current Good Manufacturing Practices (cGMPs): (21 CFR Parts 210, 211).

• Act as SME and lead the technical team at CMDO for late-phase recombinant protein antigen production and purification, including tech transfer, scale-up, gap/risk analysis, and process. characterization/qualification, cGMP manufacturing.
• Provide technical guidance and keep the project on time and in compliance with cGMP regulations.
• Review and approve controlled documents including batch records, SOPs, protocols, and reports related to process development and characterization.
• Work closely with QA/QC to identify and evaluate deviations, CAPA, and change control.
• Ensure compliance with both internal Curevo process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
• Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
• Participate in US and International specific documentation supporting the development and maintenance of products and ensuring filings meet local regulatory requirements.
• Adhere to all company policies, procedures, and safety rules as stated in the Employee Handbook and as otherwise posted or communicated.

• Minimal: University-level science degree and/or equivalent qualification.

• Minimum 3 years experience in recombinant protein process development and CMC operations.
• Experience with upstream cell culture process/production is required.
• Experience with downstream purification is required.
• Late-stage CMC experience is strongly preferred.

• Willing to perform a wide range of duties in a smaller organization on an independent level and as a team player.
• Excellent oral and written communication skills; ability to communicate effectively with co-workers and Health Authorities.
• Proficiency in MS Office [Excel, Word, PowerPoint, MS Project], JMP statistical software, and Adobe Acrobat.
• Ability to travel as required by projects (10-25% of the time, US and International).
• Ability to work flexible hours for collaboration with international CDMOs/partners.

Curevo offers its employees a generous range of compensation and benefits.
The salary range for this position is $ 110,000 - $138,000 annually. The salary range may vary based on Curevos compensation practices and an applicants qualifications and experience.
Employees have the opportunity to earn an Annual Discretionary Bonus as well as being eligible to participate in Curevos Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, a Paid Sick Leave Plan earning 1 hour of sick time for 30 hours worked, and 10 paid holidays per year.
At Curevo, we believe the highest-performing teams include people from a variety of backgrounds and experiences who respectfully challenge each other and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.
About Curevo Vaccine
Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.
Attention: Search Firms / 3rd Party Recruitment Agencies
The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire from unsolicited resumes.
Recruiters are requested not to contact or present candidates directly to our hiring managers or employees and doing so may jeopardize eligibility to work on future positions.