SENIOR MANAGER, CMC Operations

Classification: Exempt
Reports to: VP, CMC Operations

PURPOSE

The SR. CMC Operations Manager will drive the CMC programs at CDMOs for development and scale up, cGMP manufacturing, process characterization and qualification for Phase 3 clinical studies and commercial supply. CMC Operations manager will also contribute to regulatory filing and creations of policies and procedures to ensure compliance with US Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs): (21 CFR Parts 210, 211).

KEY ROLES AND RESPONSIBILITIES

• Function as SME and lead technical team at CMDO for late phase recombinant protein drug development for both Drug Substance and Drug Product, including tech transfer, scale up, gap/risk analysis, process characterization/qualification, cGMP manufacturing.
• Provide technical guidance and keep 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.
• Lead and direct the work of our partner organizations and consultants. Build strong communications and relationships with partner organizations and consultants.
• 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.
• Collaborate with CDMO for health authority inspection.
• Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
• Actively participate as member of Curevo supporting product and new business development.
• Participate for US and International specific documentation supporting 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.

PREFERRED EDUCATION

• University level science degree and/or equivalent qualification.

PREFERRED EXPERIENCE

• Minimum 5 years’ experience in process development and CMC operations. Experience with biologics preferred.
• Requires strong knowledge in drug product process validation and manufacture for lyophilized recombinant protein drugs.
• Prefer strong knowledge in protein production and purification for clinical/commercial uses.
• Experience in formulation development is desired.
• Strong understanding of the regulation requirements from FDA and other regulatory agencies.

KNOWLEDGE, SKILLS, AND ABILITIES

• 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 time, US and International).
• Ability to work flexible hours for collaboration with international CDMOs/partners.

PHYSICAL DEMANDS

Performing the responsibilities of the job requires the ability to use hands and fingers to handle or feel and manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and 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. Vision abilities required by this job include close vision. May occasionally have to lift, tug, and pull up to 25 lbs.

WORK ENVIRONMENT

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

This job will on occasion operate within a laboratory or industrial manufacturing setting. This setting will require training and correct use of personal protective equipment (PPE) commensurate with the identified risk of exposure presented. Typically, this entails safety glasses, protective shoes, and disposable gloves.

Curevo offers its employees a generous range of compensation and benefits.

The salary range for this position is $100,000 to $125,000 annually. An employee’s pay within this salary range may vary based on numerous factors, including an applicant’s qualifications and experience.

The position is also eligible for a discretionary bonus. We offer a comprehensive employee benefits program, including medical, dental, and vision insurance, a flexible spending account, a health savings account, company-provided life and AD&D insurance, long-term disability insurance, a 401(k) Plan (eligible on day 1) with company match, and cell phone reimbursement. Additionally, we have a flexible vacation plan, and we offer paid sick leave, earning 1 hour of sick time for 30 hours worked, plus 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 based on 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.