Development Associate I, Analytical Sciences

Alexion Pharmaceuticals, Inc. New Haven , CT 06501

Posted 2 months ago

Position Summary

The Development Associate I is responsible for performing assigned experimental tasks to support the development and optimization of manufacturing processes or analytical/characterization methods as well as GMP stability and release testing for Alexion's bio-therapeutic candidates. The Development Associate I will work in collaboration with other members of the Global Product Development team and across other functional areas throughout Alexion.

Principal Responsibilities

  • Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records.

  • Perform testing in the following areas: Plate based assays, U/HPLC applications (SEC-HPLC, peptide mapping, Pro A HPLC, Ion Exchange Chromatography, etc), spectrophotometric applications, and capillary/gel electrophoresis (IEF/iCE and SDS-PAGE/CE-SDS) with staining and densitometry for in-process, drug substance and drug product release and stability samples.

  • Aid in experimental studies, developing, optimizing, qualifying or supporting manufacturing processes or analytical/characterization methods for biotherapeutic candidates

  • Draft PRCs/SOPs, qualification and validation protocols and reports, and technical reports as assigned.

  • Compile data and information related to assay and instrument performance.

  • Recognize aberrant test and sample conditions and report to them to the area supervisor / manager.

  • Order, stock, and receive, label, log, and inventory laboratory supplies. Ensure proper incoming sample receipt and inventory as assigned.

  • Provide laboratory support services, clean/maintain equipment and prepare reagents/solutions.

  • Ensure training is current for all job functions performed. Attend all required company training.

  • Provide timely and legible laboratory notebook data or documentation.

  • Perform other related duties as assigned

Qualifications

  • A successful candidate will typically have 6+ months of experience working in a relevant laboratory setting

  • Knowledge of GMPs and their application in the environment is preferred.

  • Follow written procedures when conducting experiments and applying methods

  • Document procedures and data in peer-reviewed laboratory notebooks

  • Order, stock and maintain inventory of laboratory supplies

  • Participate in general laboratory operations including equipment maintenance and organization

  • Interact with Technical Operations groups, Research and external vendors

  • Able to organize his/her own work on a routine basis with supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.

  • The ability to communicate verbally and in a written format is required.

  • Proficiency with various MS Office programs, including Word, Excel, Outlook, and PowerPoint

Education

  • A successful candidate will typically hold a BS degree in Biochemistry, Chemistry, Chemical Engineering or related discipline from an accredited university.
  • LI-DD1

New Haven, CT, United States

Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.

Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Analytical Sciences

Alexion Pharmaceuticals, Inc.

Posted 2 months ago

VIEW JOBS 11/20/2018 12:00:00 AM 2019-02-18T00:00 Position Summary This position is the analytical lead for small molecule program at Alexion. The incumbent will oversee the analytical method development, validation, and transfer conducted by CROs for current and future small molecule clinical programs. In addition, the incumbent will oversee the analytical testing by CMOs and CROs for small molecule candidates and raw materials; assess assay performance and stability trending; oversee impurity characterization and control strategy setting; evaluate degradation pathways for the candidates; oversee reference standards qualification and management for small molecule candidates; be responsible for shelf life and specification determination for the candidates; and author/review CMC sections for IND and NDA filings. In conducting the responsibility of this position, the incumbent will work closely with Analytical Technical Service group in ensuring the successful validation and transfer of analytical methods to global testing network. This incumbent will represent Analytical Sciences in cross-functional project teams with senior members of process development, technical services, quality control, quality assurance, etc. Principal Responsibilities * Oversee analytical method development, phase appropriate validation, and transfer conducted by CROs for current and future small molecule programs * Oversee analytical life cycle management and post marketing commitment efforts for future small molecule commercial products * Oversee API, DP, and raw material impurity characterization and control strategy setting * Oversee analytical testing by CMOs and CROs for small molecule candidates and raw materials; assess assay performance and stability trending * Oversee reference standards qualification and management * Lead the spec and shelf life setting for small molecule candidates * Evaluate and establish degradation pathway and control strategy for small molecule candidates * Provide technical content for regulatory submissions with respect to analytical methods * Address comments from regulatory agencies regarding analytical test methods * Provide subject matter expertise for regulatory interactions including inspections and audits. * Provide technical expertise for problem solving to support clinical and commercial manufacturing * 20% domestic and international travel to CRO/CMO is required Qualifications * At least 8 years of small molecule analytical method development experience in pharmaceutical company * At least 5 years' team managing/mentoring experience * Strong knowledge of current regulatory guidelines and cGMP requirements * Strong experience in preparing regulatory submissions and responding to regulatory inquiries * Previous experience leading CMO/CRO testing a strong plus Education * Ph.D. in analytical chemistry or organic chemistry with 10+ years' experience in pharmaceutical industry * LI-DD1 New Haven, CT, United States Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com. As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. Alexion Pharmaceuticals, Inc. New Haven CT

Development Associate I, Analytical Sciences

Alexion Pharmaceuticals, Inc.