Senior Principal Scientist – Device Technical and Engineering Lead (Senior Director Equivalent)

Job Description

Sr. Principal Scientist Device Technical and Engineering Lead (Sr. Director Equivalent)

Our companys Device Product & Process Development (DPPD) Team designs develops and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our companys pipeline of combination products across a variety of therapy areas and routes of administration including inhalation implantation and injection.

Job description:

This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes. This position interacts extensively with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch. Additionally the position will ensure products and processes are developed in accordance with applicable regulatory quality company and customer requirements.

This position will lead cross-functional development teams within and external to Device Development & Technology. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development qualification and validation; and design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.

Principal Responsibilities:

• Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from concept generation/selection development verification and validation to launch readiness:

• Lead the cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical regulatory formulation commercial and other key our company functions.

• Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.

• Represent Device Development and the project-specific Device Working Groups on cross-functional teams including the Development and Commercialization Team (DCT). Additionally maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT).

• Serve as key point-of-contact with potential external device designers developers and suppliers for selected device technology platforms.

• Oversee and serve as a technical integrator of all device development activities including engineering design engineering analysis and testing medical device design controls risk management test method/fixture development design verification and validation injection molding automated assembly and human factors analysis.

• Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges device development strategy timelines milestones and risks within our Company and with external suppliers

• Author and review relevant portions of the regulatory submissions (INDs IMPDs NDAs BLAs etc.) for combination product programs under your leadership.

• Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.

• Lead/support the development implementation and continuous improvement of Device Development and Device Project Leader processes procedures and tools.

• Maintain a high level of engagement in the program-specific design controls process and design history file development.

• Stay current with new device technologies relevant worldwide regulations standards and effectively share this knowledge with others.

• Enhance our Companys professional image and competitive advantage through publications presentations patents and professional activities.

Qualifications:

• B.A./B.S in Mechanical Engineering Biomedical Engineering Industrial and System Engineering or other types of engineering plus a minimum of 15 years of combined experience in medical device and combination product development. Advanced degree is preferred.

• 5 years of leadership experience with deep working knowledge of device biologic/drug product and process development including regulatory submission and approval processes. Including development drug-device combination product or a medical device component of a combination product.

• 5 years of leadership experience of managing complex device or combination product development programs and leading cross-disciplinary project teams.

• Experience in development and commercialization of inhalation devices and/or autoinjectors is strongly preferred.

• Has broad knowledge of medical device development design controls and risk management alongside deep knowledge in device design requirement management design verification automation/process development design validation and control strategy.

• Knowledge of U.S. and global medical device and healthcare regulations including FDA combination products cGMP Quality System Regulation FDA Human Factors guidance ISO and 11040 EN 62366 Council Directive 93/42/EEC etc.

• Proven track record of applying analytical skills in product design development and validation

• Self-motivated with ability to work independently

• Proven ability to lead team members of diverse skill sets and backgrounds

• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership

• Excellent communication presentation negotiation project management and organizational skills

• Experience with leading complex development projects at an enterprise level

• Willing to travel

• Able to multi-task continuously

Required Skills:

Preferred Skills:

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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 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 salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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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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