Director, Analytical External Capabilities, Validation & Compliance (ECVC)

Job Description

Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance (ECVC).

The selected candidate will work in the Analytical Research & Development (AR&D) department within the Development Sciences and Clinical Supplies (DSCS) organization and lead a group of exceptionally talented scientists supporting externalized analytical deliverables for Biologic programs at various stages of development. The scope of the role will include realization of the AR&D 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 ~15 scientists and manage a broad portfolio of Biologics and Antibody Drug Conjugate (ADC) programs. The leader will be expected to demonstrate subject matter expertise across Biologics analytical method development and work with internal stakeholders to ensure a diverse external network exists to compliment internal capacity and capability. The candidate will also partner with Bioprocess, Quality, and interdivisional stakeholders to grow our relationships with selected vendors by leveraging our company’s ways of working and transform them into strategic partners. 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 leader seeking to lead a team of talented scientists, provide oversight to multiple programs, operate at the interface of clinical supply and commercialization, and broaden their experience in Biologics development.

Primary Responsibilities:

• Execution of AR&D’s externalization strategy and optimization of the operating model to deliver results aligned with enterprise goals.

• Oversee analytical development for all API and drug product deliverables sited at selected external partners including analytical method qualifications/transfers, technical oversight, and resolution of analytical issues.

• Oversee analytical capability build at selected external partners by identifying focus areas that support our company's current and future pipeline and working closely with internal SMEs to upskill external partners.

• Partner with internal AR&D stakeholders to ensure external capabilities and capacity are available to assure continuity of clinical supply and support registration targets.

• Ensure high quality documentation from external partners consistent with a compliance mindset.

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 leadership 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 biochemical and/or biophysical characterization.

• Demonstrated track record of working across networks to deliver exceptional results aligned with program timelines.

• Travel (Domestic and/or International) up to 20% of time.

#AR&D

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In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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