Process Development Manager

| Greater Boulder Area | Hybrid
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Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.

POSITION SUMMARY:

The Process Development Manager will work closely with Operations, Research and Development (R&D) and Quality Control/Assurance (QC/QA) teams to ensure compliance and efficient processing of ArcherDx’s products. They are responsible for all duties related to process development, including new process implementation, specification determination, process authoring, secondary supplier qualification, and new process training.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

  • Oversee or collaborate with team on technology operations, such as impact assessments and continuous improvement for change control
  • Manage the process development for commercial Operations processes in collaboration with Tech Transfer and IVD Assay Development team
  • Work independently to design and execute experiments related to development, optimization, scale-up, and characterization of all steps in an NGS assay
  • Manage the process development of commercial operations processes
  • Investigate and troubleshoot product testing and process abnormalities
  • Accurately document all necessary relevant information in a clear and concise manner per cGxP
  • Author, revise and review standard operating procedures, work instructions and travelers (batch records)
  • Collaborate with Project Management Office as needed to support process development for new processes
  • Point of contact cross functionally for progress and completion of projects
  • Lead in process improvements and cost effectiveness in manufacturing processes
  • Work closely with cross-functional teams, according to established product development timelines
  • Point of contact cross functionally for progress and completion of projects
  • Perform other duties as assigned by supervisor
  • Review, understanding, and compliance with ArcherDX HIPAA security policies and procedures.

EXPERIENCE:

  • Minimum of 5 years’ experience in laboratory testing 
  • 3+ years of experience in industry setting
  • Previous laboratory experience with statistical data analysis, Next Generation Sequencing, qPCR/PCR and general molecular biology techniques and equipment  
  • Knowledge of cGMP/CFR/FDA regulations
  • Previous demonstration of management/training skills
  • Strong leadership and communication skills

KEY ATTRIBUTES:

  • Drive and determination
  • Ability to work in a fast paced and dynamic environment
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
  • Strong communication and presentation skills
  • Self-starter
    • Driven to perform
    • Self-directed: needs little explicit direction
    • Able to organize, prioritize, and delegate tasks to efficiently move projects forward

EDUCATION:   

  • MS degree with 1-2 years of experience, or
  • BS degree with 3-5 years experience, in biology, molecular biology, biochemistry or a related field and/or equivalent combination of education and experience. 

 

In Colorado, our competitive compensation package includes a base salary starting from $106,000 per year.  In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.

Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:

  • Health, dental, vision, short- and long-term disability, and basic life insurance coverage
  • Paid time off, holiday pay, parental leave, and other health and wellness supports

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

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Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

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