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!SUMMARY
Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to lead 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 and demonstrated leadership in developing cell-based potency assays as well as binding/immunoassays. Responsibilities include a primary role in defining, developing and optimizing new potency assays, and then guiding method transfers, qualifications and validations and ultimately serving in a Subject Matter Expert role. Key to the position is a thorough understanding of the regulatory and industry standards that are required for potency methods that will ultimately contribute to our registration packages.ESSENTIAL FUNCTIONS
REQUIRED EDUCATION, EXPERIENCE and SKILLS
- Lead the Potency Assay team with responsibility for potency methods for all development programs (from early to late phase clinical development)
- Provide scientific leadership of junior staff in the Potency Assay group
- Independently develop strategy for potency assays including justification for design of assay and link to mechanism of action (MOA)
- Develop, optimize and qualify potency methods (including cell-based bioassay and ligand binding potency assays) that are intended for lot release, stability-testing, product characterization, reference standard qualification and comparability evaluation
- Author and review SOPs, development reports, and technical reports
- In partnership with QC, serve as the Subject Matter Expert (SME) in the transfer of analytical methods from Lundbeck to GMP contract labs/contract manufacturing organizations (CMOs)
- Collaborate with QC to ensure successful 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)
- Oversee routine analytical testing and coordinate study support across Quality Control (QC) and Process Development (PD) groups
- Oversee routine maintenance of laboratory equipment and the critical reagent program for potency methods
- Develop and maintain processes for tracking assay performance
- Identify and implement new technologies and innovative approaches to measure the potency of our pipeline
- Represent the Potency Assay function on cross-functional project teams
- Assist in the preparation of CMC regulatory submissions including authoring and/or review
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Accredited Ph.D. or M.S. with 8+ years of relevant experience (for Ph. D) or 12+ years relevant experience (for M.S) in biologics
- Strong technical skills including demonstrated experience in leading the development and optimization of potency assays (including cell-based bioassays) with solid understanding of requirements for transfer and validation of the method for use by QC
- In depth knowledge of cGMP regulations, compendial requirements and regulatory requirements for potency assays
- Ability to translate the mechanism of action into a cell-based assay
- Demonstrated ability to effectively and independently manage laboratory work and data, including proficiency in data and statistical analyses
- Experience with current statistical approaches to evaluating potency data e.g. parallel line analysis, determination of relative potency, USP chapters on Bioassay
- Highly competent in common software and data analysis packages
- 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
- Ph.D in cell biology, molecular biology, biochemistry or related field
- Experience managing and developing a team
- Experience in supporting regulatory submissions including authoring/review and responding to regulatory questions
- Willingness/Ability to travel up to 10% domestically and/or internationally.
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.
Please apply to Req ID 2394 via this link
Lundbeck Seattle BioPharmaceuticals is an Equal Opportunity Employer
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