Senior Director, Analytical Development

Job Description

Job Description

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform.

Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development.

We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma Your Body. Your Hope. Your Cure.

POSITION SUMMARY

The Umoja Biopharma Analytical Development Department is seeking a driven Senior Director to manage a team to support method development of release and characterization methods of Lentiviral Vector (LVV).

The ideal candidate is experienced with leading a diverse team with a broad range of analytical skills and technical expertise.

The successful candidate will work and lead effectively in a fast-paced, matrix organization of peers from other functional areas including Research, Quality, Process Development and others.

This role will also require strategic vision and deep understanding of cell and gene therapy guidance and interactions with regulatory agencies.

This position works closely with other functions in Analytical Development to deliver complete analytical packages for regulators across the globe.

This role is expected to be about 50% focused on people management, 30% on leading CMC teams and 20% on strategy.

This position plays a strategic and mentoring role in advancing Umoja's pipeline and Analytical Development capabilities.

CORE ACCOUNTABILITIES

Specific Responsibilities include :

• Responsible for establishing and on-time execution of the program-specific analytical CMC strategy in a matrix team which includes defining CQAs, assessing analytical risks and mitigating them, assessing comparability, defining the analytical control strategy, establishing, and maintaining FIH and Pivotal specifications, and defining the regulatory submission strategy.
• Responsible to identify, create and maintain effective partnerships with stakeholders from R&D, Analytical Development, Manufacturing Sciences and Technology, Supply Chain, Regulatory, Quality, Process Development, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success.
• Accountable to advance and implement analytical methods as part of process (in-process) and product (DS / DP) understanding to support Research, Process Development, MSAT and QC while striving to standardize ways of working.
• Accountable co-lead in efforts for analytical method and specification change control, as needed, throughout internally and outside testing labs.
• Serve as technical consultant on method development / qualification / validation & method transfer.
• Responsible to recruit, manage, and develop technical and managerial leadership skills to a highly technical, multi-disciplined analytical method development and characterization team of managers and individual contributors.
• Build and support a culture that encourages evaluation and development of innovative technologies to advance analytical method development and product CQAs.

REQUIREMENTS

The successful candidate will have :

PhD / MS / BS in Biology, Biochemistry, or related discipline with 10 / 12 / 15 years of relevant experience, respectively.

Equivalent combination of education and experience will be considered

• Strong leadership and team-building skills, with a history of effectively managing and developing high-performing teams.
• Expertise with managing an analytical team to deliver IND and amendments
• Served as the CMC lead for several programs with excellent communication skills up, down and across an enterprise.
• Excellent communication skills and interpersonal skills with the proven ability to build open and collaborative relationships and successfully work as a member of a multidisciplinary team

Preferred Qualifications :

• Successfully led regulatory filings and interactions with FDA
• Experience with viral vectors (e.g., AAV, LVV) and cell transduction
• Self-motivated and organized
• Ability to work in a fast-paced environment, meet deadlines, and prioritize work on multiple projects

Physical Requirements

• Ability to work onsite 5 days a week
• 100% compliance with personal protective equipment (PPE) requirements in laboratory environments, including gloves, protective clothing, and eye safety glasses.
• Perform physical tasks required for the role, including standing, walking, bending, kneeling, sitting, working your hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds.
• Project-oriented work in this role will require regular on-site presence to complete essential job-related functions.

Salary Range : $234,000 - $283,500

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral.

Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.