Director, Cmc Project Development (Nce And/Or Nbe)

Leads global Product Presentation and Device Strategy Teams (PPDST) and Chemistry, Manufacturing and Controls (CMC) teams of functional representatives from various departments and divisions. Accountable for creating an integrated CMC development strategy in collaboration with line functions and the global Asset Strategy Team (AST) to enable pharmaceutical drug candidate/asset progression from GLP tox through clinical development and global launch. Serves as the spokesperson for all CMC functions and ensures alignment among AST and technical functions and stakeholders. Partners with Clinical, Regulatory, Operations, Quality, Preclinical Safety, and Commercial organizations. Apprises CMC and Stakeholder Management of strategies, risks and mitigation plans through regular communications throughout development and in support of global filings and approvals.

This position can be based at our headquarters in North Chicago, IL, or our Bay Area site in South San Francisco, CA. Applicants desiring fully remote work will not be considered.

In scope are NBE and NBE modalities. At the same time, candidates with an exceptional track record in one modality only, i.e. NCE or NBE, are strongly encouraged to apply.

Responsibilities:

• Represents all CMC areas on the AST serving as spokesperson for the PPDST and CMC project teams and ensures information flow across the AST and all line functions. Ensures high quality science, appropriate technology solutions and exceptional inclusive and collaborative team performance are leveraged to drive compliance with global regulatory and quality requirements.
• Leads the Product Presentation and Device Strategy Team (PPDST), a key deliverable team of the AST. Develops an integrated CMC strategy considering value drivers incl. patient convenience to deliver differentiated pharmaceutical product presentations.
• Critically evaluates and integrates drug substance, drug product, control strategy and device inputs to an overarching CMC strategy and plan that aligns with corporate business objectives. Decision-making will often require assessment and integration of drug-like properties, formulation science, engineering, analytical, and device technical information in conjunction with the overall program strategy, with full consideration of current regulatory and compliance requirements.
• Leads early-stage and late-stage projects in one or more modality areas (NBE, NCE, gene/cell therapy) using a matrixed team approach. Mentors junior colleagues. May have direct reports.
• Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities. Implements creative approaches to conserve resources, and achieves efficiency with respect to time, and budget.  Serves as a mentor for functional representatives, provides feedback and input to their functional managers and identify growth needs for team members.
• Reviews contracts with Third Party Manufacturers and consultants. Develops a budget in collaboration with AST, obtains resources from functional areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan to deliver high quality with respect to science, technology, compliance and cost effectiveness.
• Leads CMC development teams for assigned projects: develops meeting agendas, apprises risks and mitigation plans with CMC management, conduct periodic reviews, to ensure that phase transition criteria are met in the most effective and resource sparing manner. Drives accountability and urgency and overall team performance and output.
• Supports and implements corporate and divisional initiatives and strategies. Promotes scientific and entrepreneurial thinking, encourages creativity, and drives quality and results with respect to science, time, budget and resources.
• Ensures compliance with regulatory, health, safety and environmental requirements. Is always informed of trends and breakthrough developments in the global technical, regulatory and compliance arena and industry practices.
• Responsible for the Quality / Module 3 content of global filings and high-quality CMC dossiers, global approvals and commercialization of products. Key member of teams that participate in communication and meetings with global Health Authorities along the development continuum.

Qualifications

• Bachelor's Degree with at least 10 years of experience in a variety of CMC functions required; Master's Degree with at least 8 years of relevant CMC experience required; or PhD with at least 6 years of relevant CMC experience required to effectively manage global teams and all CMC activities with respect to science, technology, quality, regulatory/compliance requirements, budget, risk mitigation, and resources.
• Experience with both small-molecule/NCE and biologics/NBE therapeutics is a plus, however, candidates with an exceptional track record in only one modality are strongly encouraged to apply.
• Excellent communication, leadership and influencing skills, superior team building performance in a matrixed and inclusive environment.
• Must possess superior scientific writing skills and intrinsic sense of urgency and accountability.
• Must have appropriate working knowledge of regulatory requirements and familiarity with relevant research instrumentation and techniques. 
• Must have expert knowledge of pharmaceutical sciences and the drug development process through in-depth CMC interdisciplinary experience and expertise.
• Creative in implementing entrepreneurial thinking and devising smart business solutions.
• Ensures superior team performance through maintaining high level of morale and culture in AST, PPDST and CMC teams.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. 

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