Senior Manager, CMC Operations

Description

SENIOR MANAGER , CMC Operations

Classification: E xempt
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. The CMC Operations Manager will also contribute to regulatory filings and the creation of policies and procedures to ensure compliance with the 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 the 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, and cGMP manufacturing.
• Provide technical guidance and keep projects on time and compliant 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 internal Curevo processes and policies and 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 communicating commitments to team members.
• Actively participate as a member of Curevo, supporting product and new business development.
• Participate in US and International 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.

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 the FDA and other regulatory agencies.

KNOWLEDGE, SKILLS, AND ABILITIES

• Willing to perform a wide range of duties in a smaller organization independently 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.

PHYSICAL DEMANDS

Performing the job's responsibilities 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 occasionally 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 $146,000 - $158,000 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 e mployee b enefits program , inclu ding medical, dental, and vision insurance , a f lexible s pending a ccount, a h ealth s avings a ccount, company - provided l ife and AD&D i nsurance , long-term disability i nsurance, a 401(k) Plan (eligible on day 1) with company match, and cell phone reimbursement. Additionally, we have a f lexible v acation p lan, 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 various 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.