Associate Director, Device & Combination Product Method Development & Testing

Job Description

The Associate Director of Method Development & Testing is responsible for leading a Center of Excellence (CoE) focused on developing and validating platform and innovative device/CP functional test methods with high technical rigor to support development, IND-enabling stability, commercial stability, and Design Verification. This role involves leading the method tech transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies. Additionally, the Associate Director leads, manages, and develops a team responsible for providing routine functional testing support for Device Characterization (DC) and Design Verification (DV) deliverables across development to commercialization.

Responsibilities:

• Lead a Center of Excellence (CoE) focused on developing and validating platform and innovative device/CP functional test methods with high technical rigor to support development, IND-enabling stability, commercial stability (PSS), and Design Verification (DV).

• Lead method tech transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies.

• Lead, manage, and develop a team responsible for providing routine functional testing support for Device Characterization (DC) and Design Verification (DV) deliverables across development to commercialization.

• Collaborate with Analytical Research & Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory, and Quality Control (QC) facilities to ensure that functional testing methods meet regulatory requirements, industry standards, and internal Quality Management System (QMS) compliance.

• Talent retention, training/upskilling, and recruiting of top talent as needed to deliver on pipeline and innovation projects.

• Ensure training, safety, and compliance requirements are met and roles and responsibilities are clearly understood and followed.

• aEmployee development and growth opportunities.

Qualifications:

• Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. Advanced degree (PhD) preferred.

• 8+ years of experience in method development, validation, and testing within the pharmaceutical, medical device, or combination product (preferred) industry.

• Demonstrated leadership experience in leading and managing teams, preferably in a regulated industry.

• Extensive knowledge of method development, validation, and transfer, with an understanding of regulatory requirements and industry best practices.

• Experience in collaborating with cross-functional teams including AR&D, DCRM, Quality, Regulatory, and QC facilities.

• Strong project management skills and the ability to prioritize and effectively manage a multitude of projects simultaneously.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.

NOTICE FOR INTERNAL APPLICANTS

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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

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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.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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