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Senior Manager / Associate Director, Analytical Development - Oligonucleotide

Waltham, Massachusetts; Collegeville, Pennsylvania
Closing date
May 20, 2022

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Click here to know more about GSK Biopharm. #GSKBiopharm_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 Senior Manager/ Associate Director, Analytical Development 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/ Associate Director, Analytical Development, you will contribute to internal and external development of the company's specialty drug products. We are seeking an experienced Senior manager/SME supporting development and registration of GSK's pipeline of preclinical and development-stage candidates. Develop analytical strategies for integrated early and late stage development activities in support of new product commercialization. Will be a part of a team for the generation of high-quality, on-time, and right-the-first-time data that comprise a critical component of regulatory submissions required to enable the clinical and/or commercial use of GSK products. The analytical data generated by these methods ultimately ensure the safe and effective use of our drug products in healthy volunteers and/or patients and ensure the continuity of supply of these drugs to patients. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Manage and oversee analytical activities performed at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards. Execute the strategies for product characterization with a focus on CQA assessment, and lead characterization activities at CROs/CDMOs. Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, NDA, BLA, etc.). Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards. Implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results. Partner with GMP/GDP Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: B.S. in chemistry, biology, biochemistry, or related technical discipline Minimum of 8 years of biopharmaceutical analytical experience with small molecule, oligonucleotide Experience with analytical method development, validation and transfer Experience in the biopharmaceutical industry with relevant experience in late stage product, CQA assessment Approximately 10-15% domestic and international travel is anticipated Preferred Qualifications: If you have the following characteristics, it would be a plus: Ph.D. or M.S. in chemistry, biology, biochemistry, or related technical discipline Strong understanding of product development disciplines and relationship of analytical testing to drug development Theoretical and hands-on knowledge and experience with characterization methodologies for drug substance and drug product Experience authoring regulatory files (IND, IMPD, BLA, MAA, etc.). Experience with antibody-drug conjugates (ADCs), bispecifics, mRNA, etc. Experience collaborating with third parties (CROs/CDMOs) Ability to work in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities; must be able to work well in “gray space” Why GSK? Uniting science, talent, and technology to get ahead of disease together At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK GSKBiopharm_Development 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.
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