Associate Director Sterile Product Development

Are you looking for an impactful role that leverages your technical expertise and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Sr Manager Sterile Product Development role in a rapidly growing, empowered, innovative and agile Strategic External Development organization developing transformative medicines within a vibrant GSK Boston hub could be an ideal opportunity to explore.

As aAssociate DirectorSterile Product Development, you will contribute to internal and external development of the company's sterile drug products.

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

• Manage multiple drug product development and manufacturing efforts for sterile small molecule and/or biologics drug product programs within GSK's development portfolio.
• Build strong internal and external relationships with key stakeholders to help facilitate the delivery of DP objectives. Facilitate a highly cross-functional internal and external CMC team environment through engaged leadership, collaborative interactions and a data driven, quality focused mentality.
• Provide direction and oversight for process development/scale-up/transfer activities at internal and external sites.
• Provide leadership to ensure scientific excellence in study design, data collection and interpretation, and management within scope to prospectively agreed objectives, budget and timelines.
• Provide critical analysis of program challenges and opportunities and recommend mitigation plans where necessary.
• Support clinical supply manufacturing, change control implementation and technical investigations.
• Assist project management to proactively build detailed CMC timelines with clarity to assumptions, risks and decision points.
• Prepare and keep current written CMC development strategies in alignment with overall program objectives. Presents results and progress of CMC programs to internal and external audiences as appropriate.
• Develop and document the knowledge base needed for regulatory filings. Provide subject matter expert scientific review of CMC sections of regulatory documents.

Why you?

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

• Demonstrated knowledge, experience, and successful track record in development and commercialization of small molecule and/or biologic sterile drug products.
• Demonstrated capability to lead multiple internal and external product development projects.
• Experience with drug delivery strategies of challenging compounds is highly preferred.
• Experience with Quality by Design (QbD) and Design of Experiment (DoE) studies to assess robustness and optimization of attributes of drug product formulation and/or manufacturing process.
• Working knowledge of the interrelationships between formulation, process development and drug delivery and an understanding of how preclinical, clinical, and commercial drivers affect the development pathway of drug candidates from research through life cycle management.
• Working knowledge of FDA/ICH/EMA guidelines and cGMPs, phase appropriate development strategies across IND-NDA/BLA stages and global requirements for IND, NDA, and BLA submissions (or their regional equivalents)
• Strong technical/analytical skills to identify and solve problems.
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites.
• Strong organizational skills in order to maintain a high level of productivity, innovation, and setting priorities in order to complete assignments in a timely manner and within budget.
• Exhibits high initiative, strong drive and follow-through.

Job Requirements

• BS (minimum), MS/PhD (preferred) in, Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required.
• Minimum pharmaceutical industry experience in small molecule and/or biologics sterile product development
• 8-10 years of experience with BS/MS degree
• 5 years of experience with PhD degree
• Extensive experience with vendor management.
• Requires a flexible work schedule to accommodate program priorities and international activities as needed.
• Travel (some international) will be required.

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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