Senior Potency Development Associate

Company: IowaLifeScience
Location: Bothell
Posted on: November 22, 2021

Job Description:

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Late-Stage Development and Production groups. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease! POSITION SUMMARY Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to join the Potency Assay group supporting the development of novel therapeutic antibody programs with a focus on methods to determine the potency of drug product for early through late stage clinical development programs. The successful candidate must have a strong background in performing cell-based potency assays as well as binding/immunoassays. Responsibilities include a primary role in performing potency assays to support process development, plus supporting the develop and optimization of potency assays. Responsibilities will also include supporting QC with method transfer and validation at external testing labs. ESSENTIAL FUNCTIONS

• Perform routine potency testing including samples from process development, formulation development, development stability studies, product characterization, comparability evaluations and reference standard qualification.
• Interact with multiple internal teams to coordinate testing including Analytical Development, Downstream Process Development, Quality Control and Formulations/Drug Product; provide excellent customer service with a focus on data quality and consistent turn-around times.
• Support the development, optimization and qualification of potency methods (including cell-based bioassay and ligand binding potency assays).
• Author SOPs, development reports, and technical reports.
• Support QC in the transfer of analytical methods from Lundbeck to GMP contract labs/contract manufacturing organizations (CMOs).
• Collaborate with QC to support method validation at contract labs/CMOs; support investigations and lead troubleshooting efforts as required.
• Prepare and qualify cell banks required for cell-based bioassays; partner with QC to establish and qualify GMP analytical cell banks at contract labs (suitable for use in GMP testing).
• Perform routine maintenance of laboratory equipment and the critical reagent program for potency methods.
• Support implementation of new technologies and innovative approaches to measure the potency of our pipeline molecules
• Represent the Potency Assay function on cross-functional project teams REQUIRED EDUCATION, EXPERIENCE and SKILLS
  • Accredited Master's degree with 3 years of relevant experience OR Bachelor's degree and 5 years of relevant experience.
  • Demonstrated experience with hands-on performance of potency assays (including cell-based bioassays) for biologics.
  • Experience with current statistical approaches to evaluating potency data e.g. parallel line analysis, determination of relative potency, USP chapters on Bioassay.
  • Competent in common software and data analysis packages.
  • Strong documentation and technical writing skills; experience with writing SOPs and technical reports.
  • Working knowledge of cGMP regulations, compendial requirements and regulatory requirements for potency assays.
  • Excellent communication (written and verbal), technical and organizational skills.
  • Critical thinking, troubleshooting and attention to detail.
  • Strong interpersonal skills and the ability to work in a multi-disciplinary team environment.
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
    • Accredited B.S. or M.S in cell biology, molecular biology, biochemistry or related field.
    • Experience with method development and optimization is a plus.
    • Understanding of requirements for transfer and validation of the method for use by QC is also preferred. TRAVEL:
      • Willingness/Ability to travel up to 10% domestically and/or internationally. Why Lundbeck Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify. APPLY: Please apply to Req ID 2395 via this link Lundbeck Seattle BioPharmaceuticals is an Equal Opportunity Employer

Keywords: IowaLifeScience, Seattle , Senior Potency Development Associate, Other , Bothell, Washington