Associate Director Sterile Product Development

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jan 30 2023 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/Associate Director, Sterile DP 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. Requires a flexible work schedule to accommodate program priorities and international activities. Travel (some international) will be required. As a Senior Manager/Associate Director, 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. 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 preformulation and formulation study design and/or oligonucleotide formulation study design, data collection and interpretation, 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. Build strong relationships with C(D)MOs 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. Facilitate a highly cross-functional internal and external CMC team environment through engaged leadership, collaborative interactions and a data driven, quality focused mentality. Provide critical analysis of program challenges and opportunities and recommend mitigation plans where necessary. Guide developmental activities through interactions with multidisciplinary teams and SME’s. Support clinical supply manufacturing, change control implementation 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. Provide subject matter expert scientific review of CMC sections of regulatory documents. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS (minimum), MS/PhD (preferred) in Pharmaceutical Sciences, Chemistry, Biochemistry, Chem. Engineering, or related scientific discipline required. Minimum pharmaceutical industry experience 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 10+ years of experience with BS/MS degree or 8+ years of experience with PhD degree for Associate Director role Experience with vendor management. Experience, demonstrated knowledge, and a successful track record in formulation development of biopharm sterile drug products. 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 is required. Experience with formulation, drug delivery strategies of challenging compounds and/ or lyophilized products is highly preferred. Experience leading multiple external product development projects is preferred. Experience with IND/BLA/MAA writing and/or review is highly preferred. Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong technical/analytical skills to identify and solve problems are required. 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 is highly preferred. CMO manufacturing experience 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) is highly preferred. Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites are required. 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. 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.
LI-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 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.