Director, External Capabilities, Analytical Capabilities and Operations (ACO)

Job Description Job Description: The selected candidate will work in the Pharmaceutical Analysis and Digital Technologies department within the Development Sciences and Clinical Supplies organization and lead a group of exceptionally talented scientists supporting externalized analytical deliverables for large molecule programs at various stages of development. The scope of the role will include realization of the Development Sciences and Clinical Supplies externalization strategy, driving a culture of scientific and operational excellence within our team and at our external partners, and developing talent to achieve exceptional results. The selected candidate will manage a team of ~10-12 scientists and manage a broad portfolio of Biologics, Antibody Drug Conjugate, and/or Vaccine programs. The leader will be expected to demonstrate subject matter expertise across large molecule analytical method development and qualification, proficiency in Quality Control and ability to manage relationships with strategic partners. The leader will work with internal stakeholders across Process, Quality Assurance, and Manufacturing to ensure an external network exists to supplement internal capacity and capability and drive transformation at external strategic partners by leveraging our company’s ways of working. The leader will be expected to work with direct reports and leverage their strengths to drive results while identifying opportunities to further develop each individual in alignment with their unique development plan. This role represents an excellent opportunity for a candidate seeking to lead a team of talented scientists, provide oversight of multiple programs, operate at the interface of clinical supply and commercialization, and broaden their experience in large molecule CMC development. Primary Responsibilities: Execution of DSCS’s externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals. Oversee analytical deliverables, inclusive of quality control, for all drug substance and drug product deliverables sited at external partners to ensure continuity of clinical supply (analytical method qualifications/transfers, and resolution of analytical issues under GMP regulations) Oversee external analytical capability build by working with internal SMEs to upskill strategic partners. Oversee transfer of methods to commercial QC laboratories in support of registrational targets. Ensure high-quality documentation from external partners consistent with a compliance mindset. Work with ACO leadership to optimize current operating model and shape the future direction of the team in order to bring promising pipeline candidates to patients. Education Minimum Requirements: A Ph.D. degree with a minimum of 8 years of experience OR a master’s degree with a minimum of 10 years of experience OR a bachelor’s degree with a minimum of 15 years of experience Preferred Experience & Skills: Outstanding communication, critical thinking, and negotiation skills. Project management experience including resource management, budget forecasting, and risk assessment/mitigation planning. Comfort with working in a fast-paced and dynamic environment. Strong knowledge of Biologics CMC landscape including knowledge of GMP and relevant HA guidelines. Experience with a wide variety of analytical methods, including microbiological, device, potency assay, biochemical and/or biophysical characterization. Experience working at the development/commercialization interface with a track record of moving pipeline assets to commercial products. Demonstrated track record of working across networks to deliver exceptional results. Demonstrated ability to critically review and interpret complex scientific and technical data to drive data-driven decision making Travel (Domestic and/or International) up to 10% of time #AR&D Required Skills: Adaptability, Analytical Chemistry, Analytical Method Development, Analytical Thinking, Biologics License Application (BLA), Chemistry, Chromatographic Techniques, Commercialization, Drug Development, Laboratory Research, People Leadership, People Management, Pipeline Development, Regulatory Compliance, Regulatory Submissions, Scientific Analysis, Scientific Research, Team Leadership Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The primary location for this posting is: USA - New Jersey - Rahway Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $173,200.00 - $272,600.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors includ