Skip to main content

Search jobs

Search jobs

애브비 정보

애브비의 사명은 현재의 심각한 건강 문제를 해결하고 미래의 의학적 과제를 해결하는 혁신적인 의약품을 발굴하여 세상에 내놓는 것입니다. 당사는 Allergan Aesthetics 포트폴리오 전반에 걸친 제품 및 서비스 외에도 면역학, 종양학, 신경과학, 안과, 바이러스학, 여성 건강 및 위장병학 등 여러 주요 치료 분야에 걸쳐 사람들의 삶에 커다란 영향을 미치기 위해 노력하고 있습니다. 애브비에 대한 더 자세한 정보는 www.abbvie.com을 확인해주십시오. @abbvie 를 Twitter, Facebook, Instagram, YouTube, LinkedIn에서 팔로우하십시오.

Director, Analytical R&D - New Chemical Entities

워키건, 일리노이 주 공고 ID 2006427 분류 Research and Development 분야 AbbVie

AbbVie Analytical Research &Development (Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.  Our scope includes AbbVie's diverse pipeline of innovative small molecule and therapeutic biologic medicines and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch.  We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines.  Careers in AbbVie Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.  We are looking for diverse candidates with strong scientific and leadership experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.

Position Description
For the Analytical Director position, we are seeking a highly motivated, experienced analytical scientist and leader to lead a diverse team of Ph.D., M.S. and B.S. analytical scientists supporting the development of New Chemical Entities (NCEs) drug substance and drug product from early development through commercialization.  The candidate should have extensive expertise in the development of robust, fit-for-purpose analytical control strategies, analytical method development, validation and transfer, and analytical understanding for drug substance and drug product process development, scale up and technology transfer.  He/she will lead a team that includes analytical project leads who represent global Analytical R&D on cross-functional Chemistry Manufacturing & Control (CMC) teams and are responsible for all analytical program decisions and deliverables to support program advancement through clinical development to commercial launch.  The candidate should have experience with submission and approval of Clinical Trial Applications (INDs, IMPDs, etc.) and Marketing Applications (NDAs, MAAs, etc.) for NCEs.  He/she must be able to mentor and develop scientists across a range of different experience levels and must foster productive collaborations within the global Analytical R&D organization and with R&D cross-functional partners and across functions such as Operations and Science & Technology (S&T). 

Responsibilities

  • Lead a team of analytical team leaders and scientists working with cross functional R&D partners to develop NCE pharmaceutical candidates (RSM to API to DP) from early development through NDA approval and launch.
  • Mentor analytical leads and scientists on the development of phase-appropriate analytical strategies such as impurity control, product specifications, stability and comparability for process and formulation changes involving Drug Substance and Drug Product. 
  • Collaborate across Analytical R&D and partner functions to define analytical and CMC strategies that improve the efficiency and effectiveness of the Analytical R&D organization and help position Analytical R&D as an industry leader relative to peer companies in terms of our science and product development capabilities.
  • Form strong alliances with partner functions such as Science & Technology (S&T) and QC Operations to ensure robust and effective analytical method transfers and control strategy implementation.  
  • Review and edit key regulatory documents, technical reports and analytical method packages to drive high quality regulatory submissions and source reports and ensure fit-for-purpose knowledge management. 
  • Encourage ideas and drive for continuous improvement and champion initiatives within the Analytical R&D organization and across R&D partner functions.
  • Understand and comply with AbbVie safety, quality and regulatory policies and government regulations. 
     

 


Qualifications

  • Bachelors, Masters, or PhD in Analytical Chemistry with a minimum of 18+ (B.S.), 16+ (M.S.), or 10+ (Ph.D.) years of related industry experience (advanced degree in Analytical Chemistry preferred)
  • Strong technical background in analytical chemistry is required; including direct experience with analytical technologies used routinely in the pharmaceutical industry (UPLC/HPLC, GC, IC, ICP, UV-Vis, Karl Fischer, Mass Spectrometry, NMR, X-ray diffraction, and others)
  • Experience must include leadership of analytical development programs for NCE pharmaceutical candidates across the early- and late-stages of clinical development and participation on cross-functional CMC development teams 
  • Demonstrated leadership of technical teams and effective cross-functional communication
  • Demonstrated capability to solve critical scientific and business problems
  • Demonstrated ability to implement and to grow the capabilities of an analytical organization and develop scientists into future leaders
  • Extensive experience in drug substance and drug product process development, scale-up from pilot plants to commercial facilities and analytical method transfers from R&D to commercial QC testing laboratories
  • Understanding of cGMP, cGLP and regulatory requirements for clinical development and marketing authorizations in the U.S. and OUS 
Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

최신 채용 공고

가입하여 채용 알림 받기

인재 네트워크에 가임하여 AbbVie 소식과 채용 알림을 받아보십시오.

관심 분야카테고리와 지역 옵션을 선택하십시오. “추가”를 클릭하여 채용 알림을 생성하십시오.

  • Research and Development, 워키건, 일리노이 주, 미국제거

개인정보 수집, 이용 및 정보주체의 권리에 관한 내용을 알아보시려면 당사 이용약관, 쿠키 정책, 개인정보정책을 확인하십시오. 해당 정보를 제출하면 해당 문서를 읽었으며 애브비로부터 SMS 및 이메일 채용 알림을 받는 데 동의한 것으로 간주됩니다.

최근 살펴본 채용 공고

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Click here to find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application