Senior Manager, CMC Operations

About the Role

The Senior CMC Operations Manager will drive CMC programs at CDMOs for development, scale-up, cGMP manufacturing, process characterization, and qualification for Phase 3 clinical studies and commercial supply. They will also contribute to regulatory filings and create policies to ensure compliance with FDA cGMPs (21 CFR Parts 210, 211).

Responsibilities

• Function as SME and lead the technical team at CDMOs for late-phase recombinant protein drug development (Drug Substance and Drug Product), including tech transfer, scale-up, gap/risk analysis, process characterization/qualification, and cGMP manufacturing.
• Provide technical guidance, keep projects on time, and ensure 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.
• Lead and direct the work of partner organizations and consultants, building strong communications and relationships.
• Ensure compliance with internal Curevo processes, policies, and regional regulatory requirements, focusing on quality and accuracy in communication.
• Collaborate with CDMOs for health authority inspections.
• Plan and track assigned projects/timelines and communicate commitments to team members.
• Actively participate in Curevo’s product and new business development efforts.
• Support US and international documentation for product development and maintenance, ensuring filings meet local regulatory requirements.
• Adhere to company policies, procedures, and safety rules.

Qualifications

• University-level science degree and/or equivalent qualification.
• Minimum 5 years of experience in process development and CMC operations, with biologics experience preferred.
• Strong knowledge in drug product process validation and manufacture for lyophilized recombinant protein drugs.
• Preferred knowledge in protein production and purification for clinical/commercial uses.
• Experience in formulation development is desired.
• Strong understanding of FDA and other regulatory agency requirements.

Skills

• Willingness to perform a wide range of duties independently and as a team player in a smaller organization.
• Excellent oral and written communication skills, with the 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 10-25% of the time (US and International) and work flexible hours for international collaboration.

Physical Demands

• Ability to use hands and fingers to handle or feel and manipulate keys on a keyboard.
• Occasionally required to stand, walk, reach, climb, balance, stoop, kneel, crouch, or crawl.
• Ability to read and type while sitting in front of a computer for up to 4 hours at a time.
• Close vision required; occasional lifting, tugging, and pulling up to 25 lbs.

Work Environment

• Professional office environment with standard office equipment (computers, phones, photocopiers, etc.).
• Occasional work in laboratory or industrial manufacturing settings, requiring PPE (safety glasses, protective shoes, disposable gloves).

Pay

The salary range for this position is $146,000 - $158,000 annually, with eligibility for a discretionary bonus.

Benefits

• Comprehensive benefits: medical, dental, vision insurance, flexible spending account, health savings account.
• Company-provided life and AD&D insurance, long-term disability insurance.
• 401(k) Plan with company match (eligible on day 1) and cell phone reimbursement.
• Flexible vacation plan, paid sick leave (1 hour for every 30 hours worked), and 10 paid holidays per year.

Curevo is an equal opportunity employer committed to building a diverse and inclusive culture.