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Senior Manager, CMC Project Management and Operations

Janux Therapeutics

Janux Therapeutics

Administration, Operations
San Diego, CA, USA
Posted on Thursday, June 13, 2024

Janux is seeking a Senior Manager, CMC Project Management and Operations to join its growing CMC team. As Janux grows to where it is today with multiple active Clinical programs advancing into later stage, multiple Development programs advancing toward the Clinic and several Research programs moving into Development, this role will have a high level of complexity requiring wide technical and scientific expertise, involving all phases of CMC activities. The incumbent will be expected to provide operational and project management support for cross-functional teams and internal and external stakeholders. As such, a successful candidate will possess experience and technical knowledge of CMC development, CMC Regulatory Affairs, Quality Assurance and Control, cGMP and GLP requirements.

This is an ideal position for individuals seeking a fast-paced, growing environment offering a culture of integrity, commitment, collaboration and urgency.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

  • Propose and maintain CMC project strategies, integrating activities, internal/external prerequisites and deliverables, and crucial interdependencies to achieve concrete outcomes aligned with program and corporate objectives.
  • Engage and liaise with contract manufacturing and/or analytical laboratory organizations, monitor project deliverables and ensure development and GMP manufacturing activities are progressing as planned, for supporting preclinical and clinical development.
  • Collaborate with CMC members through internal team meetings, 1 on 1’s, emails and SharePoint tools to ensure prompt, efficient, and effective communications, with high level of organization to ensure advancement on team tasks and project objectives.
  • Work closely with cross-functional Program Management teams to ensure the integration of CMC activities into corporate program and portfolio objectives.
  • Support development and implementation of project management systems and best practices to ensure consistency and operational effectiveness within and across functions such as Clinical Operations and Development, Regulatory Affairs and Quality Assurance, Therapeutic Discovery, among others.
  • Uphold, organize and guarantee the accessibility of CMC documentation required for regulatory submissions or interactions with US and ex-US health authorities.
  • Provide necessary support to the Clinical Operations and Supply Chain teams to guarantee uninterrupted availability of materials for the successful advancement of ongoing clinical trials.
  • Maintain financial accountability for assigned projects ensuring budgets are established, followed, and change controls managed appropriately. Communicate project status to stakeholders and key project participants.
  • Recognize, categorize, prioritize, and convey risks that could impact successful project execution; formulate and oversee risk mitigation and contingency strategies.
  • Manage team meetings, including setting the agenda, devising action plans, and ensuring comprehensive follow-up.
  • Travel to sites as required.
  • Other duties as assigned.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

  • Minimum Bachelor’s Degree in Life Sciences. An advanced degree and PMP certification will be prioritized.
  • Minimum 10 years of industry experience, including 5+ years of proven experience in planning and project managing of the cross functional aspects of biopharmaceutical product development.
  • Candidates with 4+ years of direct experience working within a technical operations/CMC function will be given top priority.
  • Experience working across all phases of drug development is desired (e.g. pre-clinical to phase III/commercial).
  • Demonstrated knowledge of CMC development, CMC Regulatory Affairs, Quality Assurance and Control, cGMP and GLP requirements.
  • Experience participating in and spearheading cross-functional teams and meetings thereof.
  • Experience in liaising with internal operations groups, CDMO’s and other vendors.
  • Proficient in Excel, Word, PowerPoint, SharePoint, SmartSheets and Microsoft Project.
  • Ability to travel locally and internationally up to 20%.
  • Demonstrated ability to apply best practices of project management.
  • Ability to navigate a fast-paced environment with a high degree of ambiguity.
  • Strong attention to detail and the ability to prioritize and meet deadlines.
  • Excellent written, verbal communication and group presentation skills

Compensation:

In addition to a competitive base salary ranging from $155,000 to $170,000 we offer stock options, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity and work location.

Job Type: Full-time

Benefits:

  • 401K
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Supplemental disability insurance plans
  • Flexible schedule
  • Life insurance
  • Flexible vacation
  • Sick time
  • Incentive stock option plan

Schedule:

  • Monday to Friday

Work authorization:

  • United States (Required)

Additional Compensation:

  • Annual targeted bonus %

Work Location:

  • On site (San Diego, CA)

EQUAL OPPORTUNITY EMPLOYER:

Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies

The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.