Job Description
PURPOSE
The CMC Operations Manager will drive the CMC program in development and scale up, including tech transfer, material management, planning, timeline, and budgets. Curevo is an innovative biotech looking for a CMC manager with robust experience in CMC process development and cGMP manufacturing knowledge. This individual will be expected to collaborate with Regulatory, Clinical Operations and Program Management departments across Curevo to ensure operational activities are in line with business strategy. Their focus will be on bringing in the right culture to their team and they will want to move FAST. The CMC Operations Manager plays a critical role in developing the CMC Operations Infrastructure, and managing relationships with external CMOs. They may also contribute to the process of New Drug submissions to the IND and in creating policies and procedures to ensure compliance with US Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs): (21 CFR Parts 210, 211).
ESSENTIAL RESPONSIBILITIES & DUTIES
• Experience with development and writing of CMC-related documents
• Strong understanding of regulatory guidance as it applies to CMC submissions (e.g., NDAs, MAAs, INDs, IMPDs)
• Interpret and analyze quality data related to product characterization, manufacturing process, product and process control, and stability
• Experience in tech transfer to CDMO, scale up and gap analysis
• Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines
• Lead projects independently with minimal oversight
• Interpret and analyze applicable tables, listings, and figures
• Act as a liaison between the Company, partners, consultants, and vendors
• Develop and actively manage project plans, schedule and budget to meet deliverables
• Establish project goals within broad outlines provided by top management
• Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
• Organizational expert within the CMC subject area
• Excellent written/oral communication and strong time and project management skills
• Ability to attend regular team meetings
REQUIREMENTS
• BS + in biology or chemistry, or related field, with industry experience within regulatory affairs, laboratory sciences, quality assurance/control
• Knowledge of GMP, ICH guidelines, and applicable regulatory requirements
• 3+ years of pharmaceutical CMC experience
PHYSICAL DEMANDS
Performing the responsibilities of the job requires regular use of hands to finger, handle, or feel objects, tools, or controls, and to reach with hands and arms. Frequently required to stand, walk, climb, or balance; and to stoop, kneel or crouch. May be required to walk and stand for entire work shifts. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Physically able to use and operate equipment used in clinical research and trials. Ability to lift, tug, and pull up to 50 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.
ADDITIONAL INFORMATION
· We regret that Curevo Vaccine does not provide Visa Sponsorship.
· Resumes will be reviewed in mid-February 2021 and candidates contacted in February and March for a hire that is expected to be completed in the 1st quarter of 2021.
· As part of our standard hiring process for new employees, employment with Curevo Vaccine requires pre-employment references, background checks and drug testing.
APPLICATION INSTRUCTIONS
Please submit a resume and cover letter to jobs@curevovaccine.com with the position title in the subject title. Alternatively, you may attach a combined PDF of your documents in the fill-in space at the bottom of our website jobs page.
ABOUT CUREVO VACCINE
Curevo Vaccine was founded in 2018 to develop innovative vaccines in partnership with GC Pharma and Mogam Institute for Biomedical Research. The goal of Curevo Vaccines is to support GC Pharma’s vaccine development activities, which are targeted at making and commercializing new-generation vaccines using a proprietary adjuvanted subunit vaccine technology. We are a clinical-stage biotechnology company located in Seattle, WA.
Curevo Vaccine is a proud Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
Company Description
Curevo Vaccine was founded in 2018 to develop innovative vaccines in partnership with GC Pharma and Mogam Institute for Biomedical Research. The goal of Curevo Vaccines is to support GC Pharma’s vaccine development activities, which are targeted at making and commercializing new-generation vaccines using a proprietary adjuvanted subunit vaccine technology. We are a clinical-stage biotechnology company located in Seattle, WA.