Site Name: USA - Pennsylvania - Upper Providence, UK - County Durham - Barnard Castle, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, USA - Massachusetts - Waltham
Posted Date: Oct 28 2024
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 Senior Manager, Sterile DP role in a rapidly growing, empowered, innovative and agile Strategic External Development organization developing transformative medicines within a vibrant GSK Hub could be an ideal opportunity to explore.
As a Senior Manager, Sterile DP, you will contribute to internal and external development of the company's specialty drug products and/or development of SED’s internal processes.
- Requires a flexible work schedule to accommodate program priorities and international activities.
- Travel (some international) will be required.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Provide leadership, working with internal and external partners, to ensure scientific excellence in biopharm/oligonucleotide preformulation and formulation study design (liquid and lyophilized products), data collection and interpretation, process development, and management within scope to prospectively agreed objectives, budget and timelines.
- Manage multiple drug product development and manufacturing efforts for sterile drug product programs within GSK’s development portfolio, including biologics, ADCs, and oligonucleotides.
- Build strong relationships with CMOs.
- Build strong internal and external relationships with key stakeholders (e.g., analytical, drug substance, internal manufacturing groups, project management, project coordinators) to help facilitate the delivery of DP objectives.
- Provide critical analysis of program challenges and opportunities and recommend mitigation plans where necessary.
- Support clinical supply manufacturing, batch record development, deviation management, change control implementation, CAPA ownership/ support and technical investigations as needed.
- Assist project management to proactively build detailed CMC timelines providing technical clarity, project risks, resourcing and decision points.
- Prepare and keep current written CMC development strategies in alignment with overall program objectives. Present results and progress of CMC programs to internal and external audiences as appropriate.
- Support knowledge management strategies and execution needed for regulatory filings and a commercially viable drug product.
Why you?
Basic Qualifications:
- BS or MS/PhD (preferred) in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, Materials Science or related scientific discipline required.
- Experience in the pharmaceutical industry in biologics sterile product development.
- 8+ years of experience with BS/MS degree or 5+ years of experience with PhD degree for Senior Manager level role.
- Experience in sterile drug products.
- Experience with sterile manufacturing process development and execution.
- Experience with liquid and lyophilized formulation, sterile manufacturing processes, drug delivery strategies of challenging compounds and/ or lyophilized products.
- Experience with vendor management.
Preferred Qualifications:
- Experience with formulation lyophilization and end to end manufacturing process development of ADCs and or oligonucleotides.
- CMO manufacturing experience is preferred.
- Experience with authorship and/or review of CMC sections of IND/BLA/MAA.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites.
- 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.
- Demonstrated capability to lead multiple external product development projects.
- Working knowledge of the interrelationships between formulation, process development and drug delivery and an understanding of how preclinical, clinical, and commercial drivers affect the CMC 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.
- Ability to partner within and/or across organizations to support drive toward cultural change.
- 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.
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