DescriptionCMC MANAGER , ADJUVANT
PURPOSE
The CMC Manager is responsible for managing CMC activities, ensuring compliance with regulatory standards , and aligning with project goals. This role involves managing an adjuvant drug product from late-phase development through cGMP production and BLA-enabling studies, while maintaining adherence to regulatory guidelines. The Manager is expected to coordinate timelines, budgets, resources, and multi-functional teams to achieve project goals.
KEY ROLES AND RESPONSIBILITIES
- Manage an adjuvant drug product in late-phase development.
- Provide specialized knowledge in certain areas of expertise, such as emulsification or fill/finish.
- Maintain adherence to regulatory guidelines and standards for all CMC processes.
- Review and approval of CMC documents, such as protocols, reports, batch records, etc.
- Author internal documentation, such as process documentation, SOP's, and supporting quality events.
- Support regulatory documentation drafting as needed.
- Manage internal CMC data sets.
- Analyze process data and trends using scientific and engineering principles. Coordinate timelines, budgets, resources, and multi-functional teams to achieve project goals.
- Collaborate with cross-functional teams to resolve CMC-related technical challenges.
- Mentor and develop junior CMC staff.
- Support other CMC activities as needed.
REQUIRED QUALIFICATIONS
- BA/BS degree in science, engineering, or related field.
- 4+ years of work experience in CMC or related field.
PREFERRED QUALIFICATIONS
- MS degree in science , engineering, or related field.
- Prior experience developing, scaling, or manufacturing complex drug product systems, such as oil-in-water emulsions/ nano emulsions , and/or related lipid-based delivery systems, such as LNPs/liposomes.
- Prior experience supporting sterile drug product fill/finish, including aseptic processing, visual inspection, and primary packaging.
- Prior experience with process validation and technology transfers.
KNOWLEDGE, SKILLS, AND ABILITIES
- Strong understanding of CMC processes and regulatory requirements.
- Experience in pharmaceutical development and manufacturing.
- Knowledge of US, EU regulations and guidelines, and application of GMPs.
- Strong organizational and project management skills.
- Strong technical skills, including statistical analysis, to overcome technical challenges.
- Excellent communication and collaboration skills.
- Ability to manage multiple tasks and projects simultaneously.
PHYSICAL DEMANDS
Performing the responsibilities of the job requires the ability to use hands and fingers to handle or feel and to manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop , kneel, crouch, or crawl. Ability to read and type while sitting in front of a computer 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 , including computers, phones, photocopiers, filing cabinets, and fax machines.
Curevo offers its employees a generous range of compensation and benefits.
The salary range for this position is $ 145,000 - $155,000 annually. The salary range may vary based on Curevo's compensation practices and an applicant's qualifications and experience.
Employees have the opportunity to earn an Annual Discretionary Bonus, as well as being eligible to participate in Curevo's 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, and earn 1 hour of sick time for every 30 hours worked, plus 10 paid holidays per year.
At Curevo, we believe the highest-performing teams include people from diverse backgrounds and experiences who respectfully challenge one another and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.
