Drug Product Development Director

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Jan 12 2023

Job Purpose:

• Ensures the successful development of primarily sterile drug products, and if required, non-sterile drug products, typically from Candidate Selection through to commercialization and Life Cycle, by utilizing sound judgement, knowledge and expertise, to devise and implement appropriate drug product development strategies in alignment with project plans.
• Ensures the development of patient centric, robust, reliable and high-quality drug products and the associated manufacturing processes.
• Instigates, leads or contributes to Drug Product Development strategies
• Contributes to establishment of discipline excellence in Drug Product Development for large and small molecules sterile portfolio and capability investment strategy.

Key Responsibilities:

• Serve as an active and influential member of matrix teams, such as the MPD team or other CMC related teams.
• May serve as a Drug Product Workstream Lead and/or manage DPWS leaders in their team.
• Manage the project specific interfaces both within and outside of MDS to ensure the successful progression of project plans effectively.
• Create sterile drug product development platforms aligned with GSC, where appropriate.
• Partner with GSC and other MST groups for effective integration of manufacturing activities.
• Coordinate and/or manage project specific external collaborations.
• Ensure successful transfer of the drug product formulation and manufacturing processes to the commercial site of manufacture.
• Meet with regulators as required and prepare and/or review regulatory documents to allow the progression of drug products into the clinic and onto global markets.
• Participate in the resolution of any technical issues during the clinical phase or post commercialization stage of development, with the goal of maintaining continuity of supply to patients.
• Maintain own knowledge of GMP requirements, SOPs and policies.
• Ensure appropriate application of key guidance, procedures and policies (e.g. GMP, ICH Q8, Q9, & Q10 and SOPs)
• Ensure appropriate Quality Standards are applied by:

• Ensuring that the required initial and continuing training and development plans of his/her team personnel is carried out and adapted according to need
• Checking and maintenance of areas used by his/her team, participation in regular audit and maintenance of relevant premises, equipment and processes
• Approval of Master Batch Records, sampling instructions and other Quality Control procedures as required
• Review and input into appropriate product specifications
• Review and approval of Development History Reports

• Keeps abreast of the latest scientific papers in the area of Sterile drug product development and Regulation and applies this to projects.

Communication

• Ensures timely & reliable recording of laboratory data in Labware and other suitable systems in accordance with company policy and legal requirements
• Prepares detailed oral or written reports of results in the context of strategic fit, feasibility and rationale for project
• Independently prepares and communicates recommendations for next steps to project members
• Independently authors scientific papers and internal reports
• Independently writes and edits sections for patents or regulatory submissions
• Presents effectively to internal GSK forums and external meetings
• Demonstrates networking skills through interactions across departments
• Responsible for sharing relevant scientific information from internal and external meetings to appropriate colleagues
• Responsible for sharing relevant scientific information from internal and external meetings to appropriate colleagues
• Some networking with external key opinion leaders and experts in specific therapeutic areas or scientific disciplines
• Ensures that timely reviews are scheduled of projects in conjunction with the established GSK governance process including Technical Reviews

Safety

• Ensures an effective safety culture and program is supported, including regular audits.
• Ensures any laboratories are maintained in an acceptable manner as required for safety and good laboratory practices
• Ensures that required safety training is attended and safety records maintained.
• Ensures teams complete risk assessments and exposure monitoring exercises on their compounds as appropriate.

Specific Activities

• Create an environment that stimulates, develops and promotes the scientific and career development of others
• Coach and mentor staff to help them achieve their full potential
• Manage performance of direct reports, develop their performance plans, conduct formal performance appraisals and make recommendations, when appropriate, for advancement
• Contribute to the overall operation of the department, including resource & capability planning and budget management
• Contribute, as requested, to the overall operation of DPD and MDS via participation on related strategic initiatives

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Honors degree or equivalent in an appropriate scientific discipline
• Demonstrated capability and proven track record in science and technology driven sterile dosage form design and development
• Proven ability to understand and influence both analytical and formulation aspects of product development
• Experience in the design and implementation of product development plans
• Excellent understanding of the product development process, from pre-formulation through to commercialization and post launch process improvements
• Thorough knowledge of regulatory requirements
• Broad knowledge of all preclinical disciplines
• Knowledge of manufacturing and technology transfer processes
• Has thorough working knowledge of Quality by Design with an ability to implement appropriate strategies for projects
• Demonstrated leadership skills and ability to manage a team
• Demonstrated team working skills
• Strong written and verbal communication skills
• Demonstrated ability to work with people across GSK network, influence matrix teams and colleagues in other divisions and communicate with leadership and Governance Groups
• In depth knowledge of GMP requirements, SOPs and policies relevant to product development

Preferred Qualifications:

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

• Sought out as an expert and resource in his/her scientific field
• Demonstrated ability to influence projects outside of own team and is recognized by his/her internal peers outside of immediate work group as an expert in a specific scientific or technical area
• Has knowledge of related scientific disciplines as they apply to drug discovery/development and has general understanding of key scientific areas impacting projects
• Demonstrates a detailed fundamental knowledge of the literature in own specialty area or scientific discipline
• Demonstrated proficiency in prioritizing and coordinating several areas of work
• Has track record of moving project/function forward successfully
• If applicable, effectively coordinates external collaborations
• Supervise, in an effective manner, scientists performing formulation and process development activities.

*LI-GSK

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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