Pharmacist - Drug product development at GSK in Collegeville, PA
Are you looking for an impactful role that leverages your 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 Technical Project Coordinator 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 Pharmacist - Drug Product Development within a vibrant Drug Product Development team, you will contribute to internal and external development of the company's drug products. Requires a flexible work schedule to accommodate program priorities and international activities as needed. Travel (some international) will be required. This role will provide YOU the opportunity to lead key activities to progress YOUR career. The responsibilities of the role include the following:
Schedule team meetings, manage project charter, agendas and minutes. 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 challenges and opportunities and recommend mitigation plans where necessary. Provide support for process development/scale-up/transfer activities at internal and external sites. Support clinical supply manufacturing, change control implementation and technical investigations. Support and track clinical site inquiries. Assist project management to proactively build detailed CMC timelines with clarity to assumptions, risks and decision points. Document CMC development strategies in alignment with overall program objectives. Present results and progress of CMC programs to internal and external audiences as appropriate. Any other admin duties required by the VP and the SEDLT Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required. 5
years of experience with BS/MS degree 3
years of experience with PhD degree or multiple advanced degrees Strong organizational skills. Experience working with development, manufacturing and commercialization of small molecule and/or biologic sterile drug products. Experience working with 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) Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
MS/PhD (preferred) in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required. Experience with vendor management 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. 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. Technical/analytical skills to identify and solve problems
Salary Range:
$150K -- $200K
Minimum Qualification
PharmacyEstimated Salary: $20 to $28 per hour based on qualifications.
Schedule team meetings, manage project charter, agendas and minutes. 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 challenges and opportunities and recommend mitigation plans where necessary. Provide support for process development/scale-up/transfer activities at internal and external sites. Support clinical supply manufacturing, change control implementation and technical investigations. Support and track clinical site inquiries. Assist project management to proactively build detailed CMC timelines with clarity to assumptions, risks and decision points. Document CMC development strategies in alignment with overall program objectives. Present results and progress of CMC programs to internal and external audiences as appropriate. Any other admin duties required by the VP and the SEDLT Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required. 5
years of experience with BS/MS degree 3
years of experience with PhD degree or multiple advanced degrees Strong organizational skills. Experience working with development, manufacturing and commercialization of small molecule and/or biologic sterile drug products. Experience working with 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) Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
MS/PhD (preferred) in Pharmaceutical Sciences, Chemistry, Engineering, Materials Science or related scientific discipline required. Experience with vendor management 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. 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. Technical/analytical skills to identify and solve problems
Salary Range:
$150K -- $200K
Minimum Qualification
PharmacyEstimated Salary: $20 to $28 per hour based on qualifications.
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