Director, Biologics CMC-Late Stage (Analytical/QC)
Posted on Nov 15, 2018 by Nektar Therapeutics
The Director, Biologics CMC-Late Stage (Analytical/QC), is responsible for building and leading the late-stage CMC development function within Nektar Pharmaceutical Development and Manufacturing organization with emphasis on Analytical Development, method validation and Quality Control testing. Responsible for the recombinant protein polymer conjugation process development and process characterization/validation activities leading up to BLA filing/registration and commercialization. Provides technical and managerial oversight to GMP manufacturing and QC testing at contract manufacturing organizations (CMO) in support of clinical and commercial supply and product registration activities. Responsible for IND/BLA document authoring, developing CMC related regulatory strategy, analytical methods and specification life cycle and participating/presenting at Regulatory agency meetings. Responsibilities
Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people. Directs execution of the project plan, working with and ensuring appropriate and effective input and assistance from, other functional areas. These may include groups such as, Program Management, Regulatory Affairs, Manufacturing, Quality, Life Sciences, Pharmaceutical Development and Clinical Operations. Develops long range resource budgets based on project/program plans. Has direct discretionary responsibility for completion of all issues associated with a particular project or program. Identifies and drives continuous improvement projects. Uses innovation to continuously improve the effectiveness and efficiency of the process. Has regular interaction with corporate partners and outside vendors and/or contract manufacturers. Ensures training for all staff is within compliance standards. Builds, develops, and mentors high performance work teams. Directs necessary activities to ensure project/program deliverables are on time. Anticipates cross-program issues, takes necessary steps to prevent problems and recommends solutions when problems occur. . Facilitates technology transfer between organizations and sites to meet required project goals. Directs and develops team(s) responsible for analytical methods development following cGMPs or applicable Quality compliance for pharmaceutical products and/or bulk pharmaceutical raw materials/intermediates. Provides technical guidance, leadership and decision-making as appropriate. Provides regular performance feedback, development and coaching to direct reports.Requirements
An Ph.D. or advanced degree is highly desired. A minimum of a Bachelors degree in a scientific or engineering discipline is required. Equivalent experience may be accepted. A minimum of 13 years experience in the pharmaceutical or other technology based product research, development or manufacturing industry is required (in a process/product development FDA regulated environment.) A minimum of 10 years previous management experience with senior scientific or technical staff is required. Must have extensive hands-on experience in protein characterization, methods development/validation and technology transfer to GMP manufacturing/QC testing . BLA writing and product launch experience desirable. Must have a proven track record of managing and advancing both groups and projects in a technology based industry. Strong verbal and written communication skills are required. Project management skills are required. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations. Must have a demonstrated ability to work with senior management. A proven ability to develop and manage to a budget is a must. Must be goal-oriented, quality-conscientious, and customer-focused. Good laboratory compliance and safety practices are a must. Demonstrated ability to develop successful relationships with and influence customers, both internal and external. Understands how to set expectations and negotiate proper milestones to track progress. Must have strong negotiating and influencing skills. A strong track record of leading multidisciplinary project/program teams through successful milestones is required. Must demonstrate collaborative behavior by soliciting opinions, but is also willing to make key decisions and is effective in getting the team behind the decisions. Experience in both small and large companies would be advantageous.We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.