Manager, Sterile Product Development

Waltham, MA
February 22 2021
Other, Other
Organization Type
Job Type
Are you looking for an impactful role that leverages your pharmaceutical/pharmacy background, technical skills, organizational skills and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Manager, Sterile Drug 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 for you.

As a Manager, within a vibrant Sterile Drug Product Development team, you will contribute to internal and external development of the company's drug products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Build and maintain a base of clinical site inquiries, respond to clinical site inquiries. Identify continuous improvement opportunities in the design and execution of in-use/compatibility studies. Review pharmacy manuals and investigators' brochures.
  • Coordinate drug product development and manufacturing efforts for 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.
  • Communicate program updates, challenges and opportunities and recommend mitigation plans where necessary.
  • Support clinical supply manufacturing, product and sample shipping/coordination, change control implementation and technical investigations. Provide virtual and/or on-site support for process development/scale-up/transfer activities at internal and external sites.
  • Perform executed batch record review and/or data trending for clinical products as needed.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • BS in Pharmacy, Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required.
  • A degree in pharmacy or prior experience with managing clinical site inquiries, pharmacy manuals, investigator brochures required.
  • Minimum experience:
    • 5 - 8 years of experience with BS/MS/PharmD degree
    • 3 years of experience with PhD degree or multiple advanced degrees
  • Requires a flexible work schedule to accommodate program priorities and international activities as needed.
  • Travel (some international) will be required.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • MS/PharmD/PhD in Pharmacy, Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required.
  • Prior experience with vendor management preferred.
  • Strong organizational skills.
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites.
  • High initiative, strong drive and follow-through.
  • Basic knowledge of development, manufacture and commercialization of small molecule and/or biologic sterile drug products.
  • Basic 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.
  • Basic 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)
  • Technical/analytical skills to identify and solve problems.

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:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness


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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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