Senior CMC Technical Project Leader

Company Description

Axolabs specialises in a new class of drugs whose active ingredients are chemically derived from DNA or RNA. They are called oligonucleotide or nucleic acid therapeutics. We use our many years of expertise to help our clients make them a success. Some of these drugs have already been approved and are being used successfully against diseases that were previously untreatable in some cases. New drugs from this class are added every year.

We believe in Science for a Safer World and are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization. LGC Axolabs is located in Petaluma, US, Kulmbach and Berlin, Germany.

Job Description

As a Senior CMC Project Leader, you will have the opportunity to direct multiple interdisciplinary teams including Process/Analytical Development, Process Transfer, Manufacturing, MSAT and Quality Control. Acting as the single point of accountability for each assigned client drug development project, this highly technical individual contributor role that covers end-to-end technical drug substance project leadership from toxicology/pre-clinical to late stage clinical trials including IND/NDA technical filing support.

What you’ll do

• Direct and mentor the assigned interdisciplinary teams comprised of scientists from all key CMC disciplines, with responsibility for the development and execution of client drug development projects.
• Ensure agreed manufacturing deliverables are on-time, in-full (OTIF) and of high quality.
• Represents Axolabs in client facing meetings as a technical expert in nucleic acid drug development CMC activities
• Works with key stakeholders in commercial and project management to lead the operational planning for assigned projects.
• Provides a single point of accountability for all CMC aspects for the assigned client projects, interacting as necessary with stakeholders at all levels of management internally/externally within Axolabs.
• Acts as a subject matter expert in nucleic acid CMC disciplines for Axolabs at internal X-site technical and project review request meetings.
• Key technical representative for regulatory inspections and external conferences.
• Contributes to technical and OTIF efforts within Axolabs, Petaluma and across greater Axolabs organization (Berlin and Kulmbach) through cross-site technical meetings and “Lessons-Learned” activities.
• Drive and facilitate the planning of CMC activities and corresponding technology transfers from and to other Axolabs sites for drug substance.

Qualifications

• Ph.D. (or equivalent level of experience) in a relevant scientific chemistry or life sciences based discipline, together with 10+ years of experience in CMC projects, experience in Chemistry Manufacturing and Controls teams executing drug development..
• Strong understanding of nucleic acid drug development and training in supervisory skills
• Demonstrates diverse leadership experiences and broad capabilities including: the ability to influence and collaborate with key stakeholders, coach scientists, guide the work of other CMC colleagues to achieve positive outcomes and create business impact.
• Demonstrated effectiveness in leading matrix project teams through drug development milestones including toxicology, preclinical, ICH Stability, clinical and commercial supply API manufacturing.
• Proven ability to analyze and solve complex technical physico-chemical challenges and work with the process and analytical development teams to develop options to support scale up for GMP API manufacturing even in time sensitive situations.
• Shows high level of scientific judgement and business acumen to analyze risk and lead teams through knowledge gained in process development and scale down modelling through complex process scale up.
• Heightened awareness of personal technical expertise limits and a willingness to proactively consult internal / external stakeholders to ensure quality decisions.
• Technical abilities should include a sound knowledge of the nucleic acid synthesis, cleavage and deprotection (C&D), purification and lyophilization process; with an advanced technical knowledge of analytical characterization techniques
• Detailed knowledge of GMP and relevant regulatory guidelines and requirements.

Additional Information

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid shor