Associate Director, Concept Development and Delivery

GSK; Collegeville (PA); Hybrid; USD 143,000 - 238,000; Full time

Job summary

GSK's Packaging, Device and Design Solutions team is seeking an Associate Director to integrate technical attributes, patient and user needs, and regulatory considerations for drug-device combination products. The role focuses on improving probability of technical success through design of molecules, formulations, packaging and devices.

You will join a dynamic team delivering an expanding portfolio across modalities.

Qualifications

• Bachelor's degree in a technical discipline is required.
• 8+ years design/development experience with medical devices or DDC.
• Experience with design controls and risk management.
• Experience with external technology partners and suppliers.

Responsibilities

• Lead activities to progress development programs for DDC products.
• Collaborate with Discovery, Clinical, Quality, Manufacturing and Regulatory teams.
• Identify risks and mitigation strategies using testing and modeling.
• Plan engineering studies, device characterization, verification and validation.
• Author and review key technical documents and regulatory submissions.
• Support tech transfer and manufacturing process development.
• Monitor industry trends and engage with external partners.

Skills

Design controls

Risk management

Design history file

Regulatory submission

Cross-functional collaboration

Supplier & partner management

Education

Bachelor's degree in engineering, materials science, pharmaceutics or related

Advanced degree (Master's or PhD) in engineering or related field

Job description

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D

Position Summary

GSK's Packaging, Device and Design Solutions team is charged with the delivery of robust, patient-centric devices and primary packaging solutions to enable the effective delivery of novel pharmaceuticals across all modalities and routes of administration. Our group is a multi-skilled team of Engineers and Scientists who work across all stages of the product and process development lifecycle, from the discovery interface through concept design and selection and, ultimately, the registrational submission and commercial supply.

We are looking for an enthusiastic Associate Director to integrate technical attributes, patient and user needs, business requirements, competitive landscape and technologies for drug-device combination (DDC) products. The candidate will support development efforts to improve probability of technical success of development programs through design of suitable molecules, formulations, packaging and devices for our increasingly complex DDC products. You will join a dynamic and growing team that are key to delivering an expanding portfolio.

Key Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Collaborate with internal teams within Discovery, Clinical, Commercial, Quality, Manufacturing Science and Technology, Regulatory and Drug Product Development to develop on-target patient-centric DDC products and ensure integrated product development.
• Systematically engage and influence early to understand the technical requirements and challenges, flesh out product concepts, get the designs right and proactively outline the investment requirements, tradeoffs, and risks for GSK portfolio.
• Identify technical risks, lead mitigation using testing and modelling to support device selection.
• Plan and execute engineering studies, device characterization, design verification and validation.
• Author and review key technical documentation and regulatory submission.
• Support industrialization and technology transfer of devices to manufacturing sites, including process development support, design for manufacturability and resolution of device-related challenges.
• Monitor industry trends, collaborate with academia, government organizations and professional consortiums associated with DDC products.

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in engineering, materials science, pharmaceutics or a related technical discipline.
• 8+ years of experience in design and/or development of medical devices or drug device combination products.
• Experience with design controls, risk management, design history file requirements.
• Experience working with suppliers, contract manufacturers or external technology partners.

Preferred Qualification

If you have the following characteristics, it would be a plus:

• Advanced degree (Master's or PhD) in engineering or a related field.
• Experience with parenteral delivery systems such as prefilled syringes, autoinjectors, on-body injectors and non-integral co-pack combination products.
• Experience across multiple modalities (large molecules/biologics, small molecules and vaccines) and their specific delivery challenges.
• Experience with relevant regulatory and quality frameworks for device and combination products with regulations and standards such as 21 CFR QSR, ISO 13485, ISO 14971 or equivalent.
• Experience with simulation, modeling and familiarity with statistical analysis for design evaluation.
• Experience supporting human factors engineering and usability testing.
• Ability to work in cross-functional, global teams and communicate complex technical topics clearly to non-experts and to management.
• Strong time management and organizational skills with ability to support multiple projects of varying complexity simultaneously.
• Ability to work in a complex matrix environment and to influence and lead others without hierarchical authority.
• Strong oral and technical writing skills with experience preparing protocols, reports and/or design documentation.

Work arrangement

This role is hybrid. You will be expected on-site part of the week and may travel occasionally to suppliers or other sites.

Skills

CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $142,725 to $237,875. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.